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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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M W Laboratories Inc 12/9/09

   

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  60 8th Street, N.E.
Atianta, Georgia 30309

December 9, 2009

 

VIA FEDERAL EXPRESS

 

WARNING LETTER
(10-ATL-06)

Michael A. Warshaw, CEO
M W Laboratories Inc.
2734 Ogeechee Road
Savannah, Georgia 31405

Dear Mr. Warshaw:

On December 9 through December 11, 2008, the Food and Drug Administration (FDA) conducted an inspection of your drug and cosmetic manufacturing facility located at 2734 Ogeechee Road, Savannah, Georgia 31405 and determined that your firm is a manufacturer of Over-The-Counter (OTC) drug products. The inspection documented numerous deviations (included on the Inspectional Observations (FORM FDA 483) issued to you at the close of the inspection) from the Federal Food, Drug, and Cosmetic Act ("the Act") in the manufacturing of the following OTC drug products:

Inflammation Rx Acne Care Lotion (also known as Acne Lotion)
Inflammation Rx Acne Cleanser
Inflammation Rx Deep Pain Care Cold
Inflammation Rx Deep Pain Care Hot
Inflammation Rx DTC Deep Tissue Care
Inflammation Rx Post Op Lotion
Inflammation Rx Protection Lotion
Inflammation Rx Scratch Stopper
Ocean Cosmeceuticals J Hansyd Acne Care Serum
Ocean Cosmeceuticals J Hansyd Acne Care Lotion
Ocean Cosmeceuticals J Hansyd Hand and Nail

We have determined that these eleven products are unapproved new drugs in violation of sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], and they are misbranded under sections 502(c), (e), and (o) [21 U.S.C §§ 352(c), (e),and (o)]. Certain of these products are also misbranded under section 502(f)(1) and (f)(2) [21 U.S.C. §§ 352(f)(1) and (f)(2)]. The Inflammation Rx products are further misbranded under section 503(b)(4)(B) of the Act [21 U.S.C. § 353(b)(4)(B)].

Based on the labeling collected during the inspection of your facility, and the labeling on your website, the following products manufactured by your firm are drugs within the meaning of Section 201(g) of the Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man:

Inflammation Rx Acne Care Lotion (also known as Acne Lotion)
Inflammation Rx Acne Cleanser
Inflammation Rx Deep Pain Care Cold
Inflammation Rx Deep Pain Care Hot
Inflammation Rx DTC Deep Tissue Care
Inflammation Rx Post Op Lotion
Inflammation Rx Protection Lotion
Inflammation Rx Scratch Stopper
Ocean Cosmeceuticals J Hansyd Acne Care Serum
Ocean Cosmeceuticals J Hansyd Acne Care Lotion
Ocean Cosmeceuticals J Hansyd Hand and Nail

Your products are also new drugs, as defined by Section 201(P) of the Act [21 U.S.C. § 321(P)]. Under Sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], new drugs may not be introduced or delivered for introduction into interstate commerce unless FDA-approved applications are in effect for them. None of your products are approved by FDA.

As described in detail below, some of your products are subject to - but fail to comply with - final monographs established under the OTC Drug Review. Other products that you market are not eligible for inclusion in the OTC Drug Review because, we are not aware of any evidence that these products as formulated and labeled were marketed in the United States on or before the inception of the OTC Drug Review.

Further, your products that are subject to final monographs are misbranded under sections 502(t)(1) and (f)(2) of the Act [21 U.S.C. §§ 352(f)(1) and (t)(2)] because they do not bear the indications, directions, and warnings required by these final monographs.

Your products are also misbranded under Section 502(o) of the Act [21 U.S.C. § 352(o)] because they are not listed as required by Section 510(j) of the Act [21 U.S.C. § 360(j)]. Your facility is not exempted from drug listing requirements under 21 C.F.R. § 207.10 and Section 510(g) of the Act [21 U.S.C. § 360(g)] because it is engaged in the manufacture and distribution of drugs.

In addition, the labels for your products fail to comply with the regulations under 21 CFR § 201.66 covering the format and content of OTC drug labeling. These regulations establish the criteria for ensuring OTC drug labeling information is conspicuous at the time of purchase and use. See http://www.fda.gov/cder/Offices/OTC/DrugFactsFinalRule.pdf. The failure to comply with these regulations causes your OTC drug products to be misbranded under Section 502(c) of the Act [21 U.S.C. § 352(c)].
Additionally, your products are misbranded under section 502(e)(1)(A)(ii) of the Act [21 U.S.C.
§352(e)(1)(A)(ii)] because their labels fail to distinguish active ingredients from inactive ingredients. Moreover, the Inflammation Rx products are misbranded because their labeling includes the prescription drug symbol "Rx" even though they are marketed as OTC drug products. Therefore, they are misbranded within the meaning of section 503(b)(4)(B) of the Act [21 U.S.C. § 353(b)(4)(B)].

Below is an analysis of the regulatory status of each of your OTC drug products listed above, which includes excerpts of the violative labeling and the specific new drug and misbranding charges. Note that this is not an all inclusive description of all violative labeling for your OTC drug products.

Analysis of Each Product's Regulatory Status

Inflammation Rx Acne Care Lotion (also known as Acne Lotion)

Based on its labeling, including your online brochure, Acne Care Lotion or Acne Lotion is a topical product used to treat and prevent acne, including healing sores, regulating sebaceous output and reducing bacterial reduction related to acne, and it is subject to the 0TC Final Monograph for Acne Products. As described in more detail below, your labeling of Acne Lotion is inconsistent with this 0TC final monograph and violates the labeling and other requirements under the Federal Food, Drug, and Cosmetic Act.

The labeling for Acne Lotion does not list the product's active ingredient(s). However, the labeling lists "Ingredients" and they are as follows:

"Water, Helianthus Annuus (Sunflower) Seed Oil. Prunus Anneniaca (Apricot) Kernel Oil, Niacinamide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Glycine Soja (Soybean) Oil (and)Calendula Officinalis Flower Extract (and) Tocopherol, Arctium Majus Root Extract, Triticum Vulgare (Wheat) Genn Extract, Algae Extract, Camellia Sinensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract, Sorbitol and Yeast Extract, Glycereth-7 Trimethyl Ether, Squalane, Salix Nigra (Willow) Bark Extract, Saccharomyces Lysate Extract, Saccharomyces/Copper Ferment (and) Saccharomyces/Manganese Fennent (and) Saccharomyces/Zinc Fennent, Thymus Vulgaris (Thyme) FlowerlLeaf Extract, Sodium Hyaluronate (and) Hydrolyzed Glycosaminoglycans, Arnica Montana Flower Extract, Daucus Carota Sativa (Carrot) Seed Oil, Ascorbyl Palmitate, Yeast Extract, Centipeda Cunninghamii Extract, Wasabia Japonica Root Extract, Alteromonas Fennent Extract, Yeast Extract (B Vitamin Complex), Ceramide 1,3,6 II, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, Cinnamomum Camphora (Camphor) Bark Oil, Usnea Barbata (Lichen) Extract, Panthenol, Bisabolol, Astaxanthin, Serenoa Senulata Fruit Extract, Cinnamomum Zeylanicum Bark Oil, Retinyl Palmitate, Rosmarinus Officinalis (Rosemary) Leaf Oil, Tocopherol, Aminomethyl Propanol, Acrylates/ClO-30 Alkyl Acrylate Crosspolymer,Polyglyceryl-3 Diisostearate, Leuconostoc/Radish Root Fennent Filtrate, Phenoxyethanol (and) Iodopropynyl Butylcarbamate."

The product name and other labeling for Acne Lotion represent the product as useful in treating and preventing acne. For instance, your online brochure (www.mwlabs.com/Bookl/viewbook.html) includes the following statements about Acne Lotion and its uses:

"This lotion offers a powerful combination of antioxidants, anti-inflammatory and healing agents that help reduce the stress and inflammation of the skin." "It accelerates healing of sores and open lesions, promotes normal skin function and regulates sebaceous output." " ... reduces bacterial infestation."

Based on the labeling described above, Acne Lotion is a "drug" as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because it is intended to treat disease and to affect the structure or any function of the body of man. However, Acne Lotion is not formulated and labeled in conformance with the OTC Final Monograph on Topical Acne Drug Products (21 CFR Part 333, Subpart D). Therefore, Acne Lotion is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)] and may not be legally marketed in the United States without an approved application under section 505(a) of the Act [21 U.S.C. § 355(a)]. The marketing of this product without an FDA-approved application violates sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. Your product does not have an approved application.

In evaluating the regulatory status of this product, we considered that the labeling does not differentiate between the active and inactive ingredients. Therefore, it is our position that the components listed above as "Ingredients" for Acne Lotion are all active ingredients. Under 21 C.F.R. § 201.66(b)(2) any component in a drug that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans, would be considered an active ingredient.

Furthermore, this product is misbranded under sections 502(f)(1) and (f)(2) of the Act [21 U.S.C §§ 352(f)(1) and (f)(2)] because it does not bear the indications, directions, and warnings required by the final monograph. See 21 C.F.R. § 333.350. 

Acne Lotion is further misbranded under section 502(c) of the Act [21 U.S.C. § 352(c)] because the product does not bear labeling in accordance with 21 C.F.R. § 201.66. For instance, your product's labeling lacks a "Drug Facts" panel. Moreover, Acne Lotion is misbranded under section 502(e)(1)(A)(ii) of the Act [21 U.S.C. § 352(e)(1)(A)(ii)] because it fails to distinguish between its active and inactive ingredients.

The labeling of Acne Lotion includes the prescription drug symbol "Rx" even though the product is marketed as an OTC drug product. Therefore, Acne Lotion is misbranded within the meaning of section 503(b)(4)(B) of the Act [21 U.S.C. § 353(b)(4)(B)].

In addition to the above violations, Acne Lotion is misbranded under section 502(o) of the Act [21 U.S.C. § 352(o)] because it is not included in a list required by section 510(j) of the Act [21 U.S.C. § 360(j)]. You must file with the Secretary a list of all drugs which are being manufactured for commercial distribution.

Inflammation Rx Acne Cleanser (Acne Cleanser)

Based on its labeling, including your online brochure, Acne Cleanser is a topical product used for treating and preventing acne, and, therefore, is subject to the OTC Final Monograph for Acne Products. As described in more detail below, your promotion of Acne Cleanser is inconsistent with this OTC final monograph and violates the labeling and other requirements under the Act.

The labeling for Acne Cleanser does not list the product's active ingredient(s). However, the labeling lists "Ingredients" and they are as follows:

"Water, Algae Extract, Sodium Lauroyl Sarcosinate, Glycerin, Xanthan Gum, Sucrose Cocoate, Lactic Acid, Salix Alba (Willow) Bark Extract, LactobacilluslWasabia Japonica (Wasabi) Root Ferment Extract, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Oil, Leuconostoc/Radish Root Ferment Filtrate, Phenoxyethanol (and) Iodopropynyl Butylcarbamate."

The product name and other labeling for Acne Cleanser describe the product's use to treat and prevent acne. The product's use is described in the product name itself "Inflammation Rx Acne Cleanser" and other labeling. For example, your online brochure (www.mwlabs.com/Book1/view book.html) includes the following statement about Acne Cleanser and its uses:

"It also helps to reduce the potential for clogged skin pores and prevents future acne outbreaks."

Based on the labeling described above, Acne Cleanser is a "drug" as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because it is intended to prevent and treat disease and to affect the structure or function of the body of man. The acne claims noted above subject Acne Cleanser to the requirements of the final monograph for OTC Final Monograph on Topical Acne Drug Products (21 C.F.R. § Part 333, Subpart D). Acne Cleanser is neither formulated nor labeled in conformance with this final monograph. Therefore, Acne Cleanser is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. As noted above, the marketing of this product without an FDA-approved application violates sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. You do not have an approved application for this product.

In evaluating the regulatory status of this product, we considered that the labeling does not differentiate between the active and inactive ingredients. Therefore, it is our position that the components listed above as "Ingredients" for Acne Cleanser are all active ingredients. Under 21 C.F.R. § 201.66(b)(2) any component in a drug that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans, would be considered an active ingredient.

Furthermore, this product is misbranded under sections 502(f)(1) and (f)(2) of the Act [21 U.S.C. §§ 352(f)(1) and (f)(2)] because it does not bear the indications, directions, and warnings required by the final monograph. See 21 C.F.R. § 333.350.

Acne Cleanser is further misbranded under section 502(c) of the Act [21 U.S.C. § 352(c)] because the product does not bear labeling in accordance with 21 C.F.R. § 201.66. For instance, your product's labeling lacks a "Drug Facts" panel. Additionally, Acne Cleanser is misbranded under section 502(e)(1)(A)(ii) of the Act [21 U.S.C. § 352(e)(1)(A)(ii)] because it fails to distinguish between its active and inactive ingredients.

The labeling of Acne Cleanser includes the prescription drug symbol "Rx" even though this product is marketed as an OTC drug product. Therefore, Acne Cleanser is also misbranded within the meaning of section 503(b)(4)(B) of the Act [21 U.S.C. § 353(b)(4)(B)].

In addition to the above violations, Acne Cleanser is misbranded under section 502(o) of the Act [21 U.S.C. § 352(o)] because it is not included in a list required by section 510(j)) of the Act [21 U.S.C. § 360(j)]. You must file with the Secretary a list of all drugs which are being manufactured for commercial distribution.

Inflammation Rx Deep Pain Care Cold (Deep Pain Care Cold)

Based on its labeling, including the online brochure, Deep Pain Care Cold is a topical product used to reduce inflammation associated with arthritis and muscular discomfort. As described in more detail below, Deep Pain Care Cold does not conform to the Tentative Final Monograph (TFM) for OTC External Analgesics; it is not eligible for the OTC Drug Review; and it violates various provisions of the Act.

The labeling for Deep Pain Care Cold does not list the product's active ingredient(s). However, the labeling lists "Ingredients" and they are as follows:

"Water, Dimethyl Sulfone, Eucalyptus Globulus Leaf Oil, Glycerin, Zingiber Officinale (Ginger) Root Extract, Cinnamomum Camphora (Camphor) Bark Oil, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer (and) Isohexadecane (and) Polysorbate 80, Arctium Majus Root (Burdock) Extract, Uncaria Tomentosa Extract, Menthol, Glycine Soja (Soybean) Oil (and) Calendula Officinalis Flower Extract (and) Tocopherol, Menthyl PCA, Pepper Nigrum (Black Pepper) Seed Oil, Glycine Soja (Soybean) Oil (and) Arnica Montana Flower Extract (and) Tocopherol, D-Ribose, Artemisia Absinthium (Wormwood) Oil, Centipeda Cunninghamii Extract, Xanthan Gum, Leuconosto/Radish Root Ferment Filtrate, Phenoxyethanol (and) Iodopropynyl Butylcarbamate."

The product name and other labeling for Deep Pain Care Cold describe the product's use as an external analgesic. The product's use is described in the product name itself "Inflammation Rx Deep Pain Care Cold" and the following statements on its label:

"REVOLUTIONARY RELIEF FOR INFLAMMATION"
" ... a light and fast acting pain relieving lotion that offers quick relief..."

In addition, your online brochure (www.mwlabs.com/Book1/view book.html) includes the following statement about Deep Pain Care Cold and its uses:

"A specially formulated lotion designed to help reduce inflammation and pain associated with arthritic pain and muscular discomfort."

Based on the labeling described above, Deep Pain Care Cold is a "drug" as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because it is intended to affect the structure or function of the body of man. However, we are not aware of sufficient evidence that shows Deep Pain Care Cold is generally recognized as safe and effective for its labeled uses. Nor are we aware of any evidence that a product so formulated and labeled was marketed in the United States on or before the inception of the OTC Drug Review; therefore, Deep Pain Care Cold does not qualify for evaluation under the ongoing OTC Drug Review.1 For these reasons, Deep Pain Care Cold is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321 (p)] and may not be legally marketed in the United States without an approved application under section 505(a) of the Act [21 U.S.C. § 355(a)]. Your product does not have an approved application.

In evaluating the regulatory status of this product, we considered that the labeling does not differentiate between the active and inactive ingredients. Therefore, it is our position that the components listed above as "Ingredients" for Deep Pain Care Cold are all active ingredients. Under 21 C.F.R. § 201.66(b)(2) any component in a drug that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans, would be considered an active ingredient.

Furthermore, Deep Pain Care Cold is misbranded under section 502(c) of the Act [21 U.S.C. § 352(c)] because it does not bear labeling in accordance with 21 C.F.R. § 201.66. For example, your product's labeling lacks a "Drug Facts" panel. Additionally, Deep Pain Care Cold is misbranded under section 502(e)(1)(A)(ii) of the Act [21 U.S.C. § 352(e)(1)(A)(ii)] because it fails to distinguish between its active and inactive ingredients.

The labeling of Deep Pain Care Cold includes the prescription drug symbol "Rx" even though this product is marketed as an OTC drug product. Therefore, Deep Pain Care Cold is misbranded within the meaning of section 503(b)(4)(B) of the Act [21 U.S.C. § 353(b)(4)(B).

In addition to the above violations, Deep Pain Care Cold is misbranded under section 502(o) of the Act [21 U.S.C. § 352(o)] because it is not included in a list required by section 510(j) of the Act [21 U.S.C. § 360(j)). You must file with the Secretary a list of all drugs which are being manufactured for commercial distribution.

Inflammation Rx Deep Pain Care Hot (Deep Pain Care Hot)

Based on its labeling, including the online brochure, Deep Pain Care Hot is a topical product used to reduce inflammation associated with arthritis and muscular discomfort. As described in more detail below, Deep Pain Care Hot does not conform to the TFM for OTC External Analgesics; it is not eligible for the OTC Drug Review; and it violates various provisions of the Act.

The labeling for Deep Pain Care Hot does not list the product's active ingredient(s). However, the labeling lists "Ingredients" and they are as follows:

"Water, Methyl Sulfonyl Methane (MSM), Arctium Majus Root (Burdock) Extract, Zingiber Officinate (Ginger) Root Extract, Piper Nigrum (Pepper) Seed Extract, Capsicum Annuum Extract, Artemisia Absinthium (Wormwood Oil), Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Eucalyptus Globulus Leaf Oil, Glycerin, Niacinamide, Menthol, Cinnamomum Camphora (Campohor) Bark Oil, Xanthan Gum, Eugenol, Glucosamine Sulfate, Sodium Polyacryloyldimethyl Taurate, Hydrogenated Polydecene, Trideceth-10, Phenoxyethanol, Iodobutylcarbamate."

The product name "Inflammation Rx Deep Pain Care Hot" and its labeling describe the product's use as an external analgesic. For example, the following statements appear on the label:

"REVOLUTIONARY RELIEF FOR INFLAMMATION"
"Helps reduce inflammation and pain associated arthritis and muscular discomfort"
"A warming effect to joints and tissues is evident upon application."

The online brochure (wwW.mwlabs.com/Book1/view book.html) includes the following statement about Deep Pain Care Hot and its uses:

"A specially formulated lotion designed to help reduce inflammation and pain associated with arthritic pain and muscular discomfort."

Based on the labeling described above, Deep Pain Care Hot is a "drug" as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because it is intended to affect the structure or function of the body of man. However, we are not aware of sufficient evidence that shows Deep Pain Care Hot is generally recognized as safe and effective for its labeled uses. Nor are we aware of any evidence that a product so formulated and labeled was marketed in the United States on or before the inception of the OTC Drug Review; therefore, Deep Pain Care Hot does not qualify for evaluation under the ongoing OTC Drug Review. For these reasons, Deep Pain Care Hot is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321 (p)] and may not be legally marketed in the United States without an approved application under section 505(a) of the Act [21 U.S.C. § 355(a)]. Your product does not have an approved application.

In evaluating the regulatory status of this product, we considered that the labeling does not differentiate between the active and inactive ingredients. Therefore, it is our position that the components listed above as "Ingredients" for Deep Pain Care Hot are all active ingredients. Under 21 C.F.R. § 201.66(b)(2) any component in a drug that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans, would be considered an active ingredient.

Furthermore, Deep Pain Care Hot is also misbranded under section 502(c) of the Act [21 U.S.C. § 352(c)] because the product does not bear labeling in accordance with 21 C.F.R. § 201.66. For instance, your product's labeling lacks a "Drug Facts" panel. Additionally, Deep Pain Care Hot is misbranded under section 502(e)(1)(A)(ii) of the Act [21 U.S.C. § 352(e)(1)(A)(ii)] because it fails to distinguish between its active and inactive ingredients.

The labeling of Deep Pain Care Hot includes the prescription drug symbol "Rx" even though this product is marketed as an OTC drug product. Therefore, Deep Pain Care Hot is misbranded within the meaning of section 503(b)(4)(B) of the Act [21 U.S.C. § 353(b)(4)(B)].

In addition to the above violations, Deep Pain Care Hot is misbranded under section 502(o) of the Act [21 U.S.C. § 352(o)] because it is not included in a list required by section 510(j) of the Act [21 U.S.C. § 360(j)]. You must file with the Secretary a list of all drugs which are being manufactured for commercial distribution.

Inflammation Rx DTC Deep Tissue Care (DTC Deep Tissue Care)

Based on its labeling, including the online brochure, DTC Deep Tissue Care is a topical product used to reduce inflammation of the skin, prevent bruising, and minimize scarring. As described in more detail below, DTC Deep Tissue Care does not conform to the TFM for OTC External Analgesics or to any other rulemaking under FDA's OTC Drug Review; it is not eligible for the OTC Drug Review; and it violates various provisions of the Act.

The labeling for DTC Deep Tissue Care does not list the product's active ingredient(s).However, the labeling lists "Ingredients" and they are as follows:

"Water, Helianthus Annuus (Sunflower) Seed Oil, Glycine Soja (Soybean) Oil (and) Calendula Officinalis Flower Extract (and) Tocopherol, Zingiber Officinale (Ginger) Root Extract, Glycine Soja (Soybean) Oil (and) Arnica Montana Flower Extract (and) Tocopherol, Arctium Majus Root (Burdock) Extract, Niacinamide, Camellia Sinensis Leaf Extract, Ruscus Aculeatus Root Extract (Butchersbroom), Algae Extract, Centipeda Cunninghamii Extract, Panthenol, Prunus Anneniaca (Apricot) Kernel Oil, Saccharomyces Lysate Extract, Saccharomyces/Copper Ferment (and) SaccharomyceslManganese Ferment (and) Saccharomyces/Zinc Ferment, Saccharomyces/Calcium Ferment, Saccharomyces/Selenium Ferment, Glycerin, Tochpherol, Lecithin (and) Escin, Uncaria Tomentosa Extract, Sodium Hyaluronate, Ascorbyl Palmitate, Honey, Eugenol, AcrylatesNinyl Isodecanoate Crosspolymer, Polyglyceryl-3 Diisostearate, Glycereth-7 Trimethyl Ether, Aminomethyl Propanol, Xanthan Gum, Leuconostoc/Radish Root Ferment Filtrate, Phenoxyethanol (and) Iodopropynyl Butylcarbamate."

The product name "Inflammation Rx DTC Deep Tissue Care" and its labeling describes the product's use as an external analgesic. For example, the following statements appear on its label:

"a powerful combination of antioxidants and anti-inflammatories that help reduce stress and inflammation of the skin."

Your online brochure (www.mwlabs.com/Book1/view book.html) includes the following statements about DTC Deep Tissue Care and its uses:

"A uniquely formulated lotion that helps to reduce inflammation as well as minimize and potentially prevent bruising."

"Can be used in conjunction with Post-Op to minimize scarring."

Based on the labeling described above, DTC Deep Tissue Care is a "drug" as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because it is intended to affect the structure or function of the body of man. However, we are not aware of sufficient evidence that shows DTC Deep Tissue Care is generally recognized as safe and effective for its labeled uses. Nor are we aware of any evidence that a product so formulated and labeled was marketed in the United States on or before the inception of the OTC Drug Review; therefore, DTC Deep Tissue Care does not qualify for evaluation under that review. For these reasons, DTC Deep Tissue Care is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)] and may not be legally marketed in the United States without an approved application under section 505(a) of the Act [21 U.S.C. § 355(a)]. Your product does not have an approved application.

In evaluating the regulatory status of this product, we considered that the labeling does not differentiate between the active and inactive ingredients. Therefore, it is our position that the components listed above as "Ingredients" for Deep Tissue Care are all active ingredients. Under 21 C.F.R. § 201.66(b)(2) any component in a drug that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans, would be considered an active ingredient.

Furthermore, DTC Deep Tissue Care is misbranded under section 502(c) of the Act [21 U.S.C. § 352(c)] because the product does not bear labeling in accordance with 21 C.F.R. § 201.66. For instance, your product's labeling lacks a "Drug Facts" panel. Additionally, DTC Deep Tissue Care is misbranded under section 502(e)(1)(A)(ii) of the Act [21 U.S.C. § 352(e)(1)(A)(ii)] because it fails to distinguish between its active and inactive ingredients.

The labeling of DTC Deep Tissue Care includes the prescription drug symbol "Rx" even though this product is marketed as an OTC drug product. Therefore, DTC Deep Tissue Care is misbranded within the meaning of section 503(b)(4)(B) of the Act [21 U.S.C. § 353(b)(4)(B)].

In addition to the above violations, DTC Deep Tissue Care is misbranded under section 502(o) of the Act [21 U.S.C. § 352(o)] because it is not included in a list required by section 510(j) of the Act [21 U.S.C. § 360(j)]. You must file with the Secretary a list of all drugs which are being manufactured for commercial distribution.

Inflammation Rx Post Op Lotion (Post Op Lotion)

Based on its labeling and the online brochure, Post Op Lotion is used to reduce inflammation and scarring and accelerate the skin's healing process. As described in more detail below, Post Op Lotion does not conform to the TFM for OTC External Analgesics or to any other rulemaking under FDA's OTC Drug Review; it is not eligible for the OTC Drug Review; and it violates various provisions of the Federal Food, Drug, and Cosmetic Act.

The labeling for Post Op Lotion does not list the product's active ingredient(s). However, the labeling lists "Ingredients" and they are as follows:

"Water, Prunus Armeniaca (Apricot) Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil,Sorbitol and Yeast Extract, Niacinamide, Triticum Vulgare (Wheat) Germ Extract, Glycine Soja (Soybean) Oil (and) Calendula Officinalis Flower Extract (and) Tocopherol, Saccharomyces Lysate Extract, Arctium Majus Root Extract, Glycosaminoglycans, Glycine Soja (Soybean) Oil (and) Arnica Montana Flower Extract (and) Tocopherol, Saccharomyces/Copper Ferment (and) Saccharomyces/Manganese Ferment (and) Saccharomyces/Zinc Ferment, Alteromonas Ferment Extract, Zingiber Officinate (Ginger) Root Extract, Algae Extract, Ceramide 3 (and) Ceramide 6 (and) Ceramide I (and) Phytosphingosine, Cholesterol (and) Sodium Lauroyl Lactylate (and) Carbomer (and) Xanthan Gum, Camellia Sinensis Leaf Extract, Sodium Hyaluronate, Sqalane Oil, Ascorbyl Palmitate, Yeast Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Glycereth-7 Trimethyl Ether, Retinyl Palmitate, Water (and) Sodium Hyaluronate (and) Hydrolyzed Glycosaminoglycans, Ubiquinone (Q10), Bisabolol, Saccharomyces/Calcium Ferment, Saccharide Isomerate, Panthenol, Tocopherol, C 10-30 Cholesterol/Lanosterol Esters, Yeast Extract, Super Oxide Dismutase, Water (and) Alcohol (and) Magnesium Ascorbyl Phosphate (and) Lecithin (and) Xanthan Gum, Allantoin, Progesterone, Acrylates/CIO-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Polyglyceryl-3 Diisostearate, Phenyl Trimethicone, Phenoxyethanol (and) Iodopropynyl Butylcarbamate, Astaxanthin, Laveandula Angustifolia (Lavender) Oil, Geranium Maculatum Oil, Leuconostoc/Radish Root Ferment Filtrate,"

The product's name "Post-Op Lotion" and the claims and representations on its labeling describe the product's use as an OTC external analgesic and for other uses. For example, the following statements appear on its label:

"HELPS REDUCE INFLAMMATION AND SCARRING ACCELERATES SKIN'S HEALING PROCESSES"

Your online brochure (www.rnwlabs.com/Book1/view book.html) includes the following statements about Post Op Lotion and its uses:

"an incredible scar and keloid reducing formula"
"helps to reduce inflammation and scarring"
"accelerate the skin's healing processes"

Based on the labeling described above, Post Op Lotion is a "drug" as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because it is intended to affect the structure or function of the body of man. However, we are not aware of sufficient evidence that shows Post Op Lotion is generally recognized as safe and effective for its labeled uses. Nor are we aware of any evidence that a product so formulated and labeled was marketed in the United States on or before the inception of the OTC Drug Review; therefore, Post Op Lotion does not qualify for evaluation under the ongoing OTC Drug Review For these reasons, Post Op Lotion is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321 (p)] and may not be legally marketed in the United States without an approved application under section 505(a) of the Act [21 U.S.C. § 355(a)]. Your product does not have an approved application.

In evaluating the regulatory status of this product, we considered that the labeling does not differentiate between the active and inactive ingredients. Therefore, it is our position that the components listed above as "Ingredients" for Post Op Lotion are all active ingredients. Under 21 C.F.R. § 201.66(b)(2) any component in a drug that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans, would be considered an active ingredient.

Furthermore, Post Op Lotion is misbranded under section 502(c) of the Act [21 U.S.C. § 352(c)] because the product does not bear labeling in accordance with 21 C.F.R. § 201.66. For instance, your product lacks a "Drug Facts" panel. Additionally, Post Op Lotion is misbranded under section 502(e)(1)(A)(ii) of the Act [21 U.S.C. § 352(e)(1)(A)(ii)] because it fails to distinguish between its active and inactive ingredients.

The labeling of Post Op Lotion includes the prescription drug symbol "Rx" even though this product is marketed as an OTC drug product. Therefore, Post Op Lotion is misbranded within the meaning of section 503(b)(4)(B) of the Act [21 U.S.C. § 353(b)(4)(B)].

In addition to the above violations, Post Op Lotion is misbranded under section 502(o) of the Act [21 U.S.C. § 352(o)] because it is not included in a list required by section 510(j) of the Act [21 U.S.C. § 360(j)]. You must file with the Secretary a list of all drugs which are being manufactured for commercial distribution.

Inflammation Rx Protection Lotion (Protection Lotion)

Based on its labeling and the online brochure, Protection Lotion is used for treating inflamed skin, dermatitis, eczema, and radiation bums; reducing decubitus ulcers among the elderly; and preventing stretch marks; and it is subject to the OTC Final Monograph for Skin Protectant Drug Products. As described in more detail below, your promotion of Protection Lotion is inconsistent with the labeling requirements under this final monograph and violates various provisions of the Act.

The labeling for Protection Lotion does not list the product's active ingredient(s). However, the labeling lists "Ingredients" and they are as follows:

"Water, Helianthus Annuus (Sunflower) Seed Oil, Glycine Soja (Soybean) Oil (and) Calendula Officinalis Flower Extract (and) Tocopherol, Glycereth-7 Trimethyl Ether, Algae Extract, Water (and) Triticum Vulgare (Wheat) Germ Extract, Foeniculum Vulgare (Fennel Seed) Extract, Prunus Anneniaca (Apricot) Kernel Oil, Camellia Sinensis Leaf Extract, Yeast Extract, Bisabolol, Panthenol, Saccharide Isomerate, Saccharomyces/Copper Ferment (and) Saccharomyces/Manganese Ferment (and) Saccharomyces/Zinc Ferment, Saccharomyces/Calcium Ferment, Allantoin, Saccharomyces Lysate Extract, Sodium Hyaluronate, C10-30 Cholesterol/Lanosterol Esters, Ascorbyl Palmitate, Niacinamide, Ceramide 3 (and) Ceramide 6 (and) Ceramide 1 (and) Phytosphingosine (and) Cholesterol (and) Sodium Lauroyl Lactylate (and) Carbomer (and) Xanthan Gum, Tocopherol, Sorbitol (and) Yeast Extract, Squalane Oil, Honey, Xanthan Gum, Acrylates/CI0-30 Alkyl Acrylate Crosspolymer, Glycerin, Polyglyceryl-3 Diisostearate, Phenyl Trimethicone, Aminomethyl Propanol, Leuconostoc/Radish Root Ferment Filtrate, Phenoxyethanol (and) Iodopropynyl Butylcarbamate."

The product's uses are described in the online brochure (www.mwlabs.com/Book1/view book.html):

"Protection Lotion is a unique lotion formulated for inflamed skin conditions such as atopic dermatitis, radiation bums and stretch mark prevention."
"This lotion has demonstrated effectiveness for prevention and treatment of stretch marks and may reduce the risk of decubitus ulcers among the elderly."
"Eczema and contact dermatitis may also be controlled successfully ... "

Based on the labeling described above, Protection Lotion is a "drug" as defined by section 201(g)(1) of the Act [21 U.S.C. § 321 (g)(l)] because it is intended to treat disease and to affect the structure or function of the body of man. The eczema claims noted above subject Protection Lotion to the requirements of the OTC Final Monograph for Skin Protectant Drug Products (21 C.F.R. Part 347). Protection Lotion is neither formulated nor labeled in conformance with this final monograph. In addition, the labeled claims for decubitus ulcers, atopic dermatitis, radiation bums and stretch marks, noted above, are not covered by FDA's OTC Drug Review.

Therefore, Protection Lotion is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)] and may not be legally marketed in the United States without an approved application under section 505(a) of the Act [21 U.S.C. § 355(a)]. As noted above, the marketing of this product without an FDA-approved application violates sections 301(d) and 505(a) of the Act [21 U.S.C.§§ 331(d) and 355(a)]. Your product does not have an approved application.

In evaluating the regulatory status of this product, we considered that the labeling does not differentiate between the active and inactive ingredients. Therefore, it is our position that the components listed above as "Ingredients" for Protection Lotion are all active ingredients. Under 21 C.F.R. § 201.66(b)(2) any component in a drug that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans, would be considered an active ingredient.

Furthermore, this product is misbranded under sections 502(f)(1) and (f)(2) of the Act [21 U.S.C. §§ 352(f)(1) and (f)(2)] because it does not bear the indications, directions, and warnings required by the applicable final monograph. See 21 C.F.R. §§ 347.50 and/or 347.60.

Protection Lotion is further misbranded under section 502(c) of the Act [21 U.S.C. § 352(c)] because the product does not bear labeling in accordance with 21 C.F.R. § 201.66. For instance, your product's labeling lacks a "Drug Facts" panel. Additionally, Protection Lotion is misbranded under section 502(e)(1)(A)(ii) of the Act [21 U.S.C. § 352(e)(1)(A)(ii)] because it fails to distinguish between its active and inactive ingredients.

The labeling of Protection Lotion includes the prescription drug symbol "Rx" even though this product is marketed as an OTC drug product. Therefore, Protection Lotion is misbranded within the meaning of section 503(b)(4)(B) of the Act [21 U.S.C. § 353(b)(4)(B)].

In addition to the above violations, Protection Lotion is misbranded under section 502(o) of the Act [21 U.S.C. § 352(o)] because it was not included in a list required by section 510(j) of the Act [21 U.S.C. § 360(j)]. You must file with the Secretary a list of all drugs which are being
manufactured for commercial distribution.

Inflammation Rx Scratch Stopper

Based on its labeling, including the online brochure, Scratch Stopper (also known as Scratch Stopper Lotion) is a topical product used to reduce inflammation and irritation associated with minor skin irritation, insect bites and minor sunburn and is subject to the OTC Final Monograph for Skin Protectant Drug Products. As described in more detail below, the labeling of Scratch Stopper is inconsistent with this OTC final monograph and violates the labeling and other provisions of the Act.

The labeling for Scratch Stopper does not list the product's active ingredient(s). However, the labeling lists "Ingredients" and they are as follows:

"Water, Helianthus Annuus (Sunflower)Seed Oil, Prunus Armeniaca (Apricot) Kernel Oil, Arctium Majus Root Extract, Cucurbita Pepo (Pumpkin) Seed Extract, Glycine Soja (Soybean) Oil (and) Calendula Officinalis Flower Extract (and) Tocopherol, Algae Extract, Camellia Sinensis Leaf Extract, Petasites Japonicus (Butterbur) Root Extract, Sodium Hyaluronate, Alteromonas Ferment Extract, Bisabolol, Camphora (Camphor) Bark Oil, Menthol, Ceramide 3 (and) Ceramide 6 (and) Ceramide l(and) Phytosphingosine (and) Cholesterol (and) Sodium Lauroyl Lactylate (and) Carbomer (and) Xanthan Gum, Polyglyceryl-3 Diisostearate, Tocopherol, Eugenol, Acrylates/CIO-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Leuconostoc/Radish Root Ferment Filtrate, Phenoxyethanol (and) Iodopropynyl Butylcarbamate."

The product name and other statements and representations on the labeling for Scratch Stopper describe the product's use as a skin protectant. For example, the following statement appears in the online brochure (www.mwlabs.com/Book1/view book.html):

"formulated to help reduce the inflammation and irritation associated with minor skin rritations, insect bites and minor sunburn."

Based on the labeling described above, Scratch Stopper is a "drug" as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because it is intended to affect the structure or function of the body of man. The skin protectant claims that include the treatment of skin irritation from insect bites, subjects Scratch Stopper to the requirements of the final monograph for OTC Skin Protectant Drug Products (21 CFR Part 347). Scratch Stopper is neither formulated nor labeled in conformance with this final monograph. Therefore, Scratch Stopper is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. As noted above, the marketing of this product  without an FDA-approved application violates sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. Your product does not have an approved application.

In evaluating the regulatory status of this product, we considered that the labeling does not differentiate between the active and inactive ingredients. Therefore, it is our position that the components listed above as "Ingredients" for Scratch Stopper are all active ingredients. Under 21 C.F.R. § 201.66(b)(2) any component in a drug that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans, would be considered an active ingredient.

Furthermore, this product is misbranded under sections 502(f)(1) and (f)(2) of the Act [21 U.S.C.§§ 352(f)(1) and (f)(2)] because it does not bear the indications, directions, and warnings required by the applicable final monograph. See 21 C.F.R. §§ 347.50 and/or 347.60.
Scratch Stopper is further misbranded under section 502(c) of the Act [21 U.S.C. § 352(c)] because the product does not contain the required labeling information in an OTC Drug Facts Panel in accordance with 21 C.F.R. § 201.66. For instance, your product's labeling lacks a "Drug Facts" panel. Additionally, Scratch Stopper is misbranded under section 502(e)(1)(A)(ii) of the Act [21 U.S.C. § 352(e)(1)(A)(ii)] because it fails to distinguish between its active and inactive ingredients.

The labeling of Scratch Stopper includes the prescription drug symbol "Rx" even though this product is marketed as an OTC drug product. Therefore, Scratch Stopper is misbranded within the meaning of section 503(b)(4)(B) of the Act [21 U.S.C. § 353(b)(4)(B)].

In addition to the above violations, Scratch Stopper is misbranded under section 502(o) of the Act [21 U.S.C. § 352(o)] because it was not included in a list required by section 510(j) of the Act [21 U.S.C. § 360(j)], You must file with the Secretary a list of all drugs which are being manufactured for commercial distribution.

Ocean Cosmeceuticals J Hansyd Acne Care Lotion (Acne J Hansyd Acne Care Lotion)

Based on its labeling, Acne J Hansyd Acne Care Lotion is a topical product used for treating and preventing acne, reducing bacteria, accelerating healing and other purposes and is subject to the OTC Final Monograph for Acne Drug Products. As described in more detail below, your labeling of Acne Lotion is inconsistent with this OTC final monograph and violates the labeling and other requirements under the Act.

The labeling for Acne J Hansyd Acne Care Lotion does not list the product's active ingredient(s). However, the labeling lists "Ingredients" and they are as follows:

"Helianthus Annuus (Sunflower) Seed Oil, Prunus Anneniaca (Apricot) Kernel Oil, Niacinamide, Arctium Majus Root Extract (Burdock), Calendula Officinalis Flower, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thymus Vulgaris (Thyme) FlowerlLeafExtract, Sorbitol, Yeast Extract, Zingiber Officinale Extract, (Marine) Algae, Salix Nigra (Willow) Bark Extract, Saccharomyces/Copper Ferment (and) Saccharomyces/Manganese Ferment (and) Saccharomyces Zinc Ferment, and Saccharomyces Calcium Ferment (and) Saccharomyces/Selenium Ferment, Saccharomyces Lysate Extract, Squalane Oil, Camellia Sinensis Leaf Extract, Triticum Vulgare (Wheat) Germ Extract, (Alpha) Bisabolol, Hydrolyzed Glycosaminoglycans, Sodium Hyaluronate, Alteromonas Ferment Extract, Ipomoea Batatas Leaf Extract, Cinnamomum Camphora (Camphor) Bark Oil, Wasabia Japonica Root Extract, Ascorbyl Palmitate, Serenoa Serrulata Fruit Extract, Silybum Marianum Extract, Arnica Montana Flower Extract, Usnea Barbata (Lichen) Extract, Astaxanthin, Ceramide 3 Ceramide 6 Ceramide 1, Phytosphingosine (and) Cholesterol (and) Sodium Lauroyl Lactylate, Cinnamomum Zeylanicum Bark Extract, Rosmarinus Officinalis (Rosemary) Leaf Oil, Centipeda Cunninghamii Extract, Daucus Carota Sativa (Carrot) Seed Oil, Yeast Extract, Panthenol, Retinal Palmitate, Yeast Extract, AlphaTocopherol, Aminomethylpropanol, Acrylates/CIO-30 Alkyl Acrylate Crosspolymer, Carbomer, Glycereth-7 Methoxides, Phenoxyethanol, Iodopropynyl Butylcarbamate."

The product name and other labeling for J Hansyd Acne Care Lotion describe the product's use to treat and prevent acne. For example, the following statements appear on the product label:

"HELPS REDUCE STRESS AND INFLAMMATION OF ACNE SKIN."
"ACCELERATES HEALING, REGULATES SEBACEOUS OUTPUT REDUCES BACTERIA"

Based on the labeling described above, J Hansyd Acne Care Lotion is a "drug" as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because it is intended to treat disease and to affect the structure or function of the body of man. The acne claims noted above subject J Hansyd Acne Care Lotion to the requirements of the final monograph for OTC Topical Acne Drug Products (21 C.F.R. Part 333, Subpart D). J Hansyd Acne Care Lotion is neither formulated nor labeled in conformance with this final monograph. Therefore, J Hansyd Acne Care Lotion is a "new drug" under section 201(p) of the Act [21 U.S.C. §§ 321(p)]. As noted above, the marketing of this product without an FDA-approved application violates sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. Your product does not have an approved application.

In evaluating the regulatory status of this product, we considered that the labeling does not differentiate between the active and inactive ingredients. Therefore, it is our position that the components listed above as "Ingredients" for J Hansyd Acne Care Lotion are all active ingredients. Under 21 C.F.R. § 201.66(b)(2) any component in a drug that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans, would be considered an active ingredient.

Furthermore, this product is misbranded under sections 502(f)(1) and (f)(2) of the Act [21 U.S.C. §§ 352(f)(1) and (f)(2)] because it does not bear the indications, directions, and warnings required by the final monographs. See 21 C.F.R. § 333.350.

J Hansyd Acne Care Lotion is further misbranded under section 502(c) of the Act [21 U.S.C. § 352(c)] because the product does not bear labeling in accordance with 21 C.F.R. § 201.66. For instance, your product's labeling lacks a "Drug Facts" panel. Additionally, J Hansyd Acne Care Lotion is misbranded under section 502(e)(1)(A)(ii) of the Act [21 U.S.C. § 352(e)(1)(A)(ii)] because it fails to distinguish between its active and inactive ingredients.

In addition to the above violations, J Hansyd Acne Care Lotion is further misbranded under section 502(0) of the Act [21 U.S.C. § 352(0)] because it was not included in a list required by section 510(j) of the Act [21 U.S.C. § 360(j)], You must file with the Secretary a list of all drugs which are being manufactured for commercial distribution.

Ocean Cosmeceuticals J Hansyd Acne Care Serum (J Hansyd Acne Care Serum)

Based on its labeling, J Hansyd Acne Care Serum is a topical product that treats and prevents acne and is subject to the aTC Final Monograph for Acne Drug Products. As described in more detail below, your labeling of J Hansyd Acne Care Serum is inconsistent with this OTC final monograph and violates the labeling and other requirements of the Act.

The labeling for J Hansyd Acne Care Serum does not list the product's active ingredient(s). However, the labeling lists "Ingredients" and they are as follows:

"Water Niacinamide, Triticum Vulgare (Wheat) Germ Extract, Sodium Hyaluronate, Saccharomyces Lysate Extract, Sorbitol, Yeast Extract, Arctium Majus Root Extract (Burdock), Salicylic Acid, Polysorbate 80, Glyceryl Stearate, Cocamidopropyl Dimethylamine, Zea Mais (Corn Starch), Hydrolyzed Com Starch, Hydrolyzed Corn Starch Octenylsuccinate, Glycerin, Algae, Yeast Extract, Glycereth-7 Methoxides, Yeast Extract, Saccharomyces/Copper Ferment (and) Saccharomyces/Manganese Ferment (and) Saccharomyces Zinc Ferment, and& Saccharomyces Calcium Ferment (and) Saccharomyces/Selenium Ferment, Wasabia Japonica Root Extract, Centipeda Cunninghamii, Ipomoea Batatas Leaf Extract, Saccharide Isomerate, Perfluorodecalin, Xanthan Gum, Aminomethylpropanol, Carbomer, Phenoxyethanol, Iodopropynyl Butylcarbamate."

The name "J Hansyd Acne Care Serum" and other product labeling represents this product as useful in treating and preventing acne. For example, the following statement appears on its label:

"Soothes inflamed skin and reduces bacteria."

Based on the labeling described above, J Hansyd Acne Care Serum is a "drug" as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because it is intended to treat disease and to affect the structure or function of the body of man. The acne claims described above subject J Hansyd Acne Care Serum to the requirements of the final monograph for OTC Acne Drug Products (21 C.F.R. Part 333, Subpart D). J Hansyd Acne Care Serum is neither formulated nor labeled in conformance with this final monograph. Therefore, J Hansyd Acne Care Serum is a "new drug" under section 201(p) of the Act [21 U.S.C. §§ 321(p)]. The marketing of this product without an FDA-approved application violates sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. You do not have an approved application for this product.

In evaluating the regulatory status of this product, we considered that the labeling does not differentiate between the active and inactive ingredients. Therefore, it is our position that the components listed above as "Ingredients" for J Hansyd Acne Care Serum are all active ingredients. Under 21 C.F.R. § 201.66(b)(2) any component in a drug that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans, would be considered an active ingredient.

Furthermore, this product is misbranded under sections 502(f)(1) and (f)(2) of the Act [21 U.S.C. §§ 352(f)(1) and (f)(2)] because it does not bear the indications, directions, and warnings required by the applicable final monograph. See 21 C.F.R. § 333.350.

J Hansyd Acne Care Serum is further misbranded under section 502(c) of the Act [21 U.S.C. § 352(c)] because the product does not bear labeling in accordance with 21 C.F.R. § 201.66. For instance, your product's labeling lacks a "Drug Facts" panel. Moreover, J Hansyd Acne Care Serum is misbranded under section 502(e)(1)(A)(ii) of the Act [21 U.S.C. § 352(e)(1)(A)(ii)] because it fails to distinguish between its active and inactive ingredients.

In addition to the above violations, J Hansyd Acne Care Serum is misbranded under section 502(o) of the Act [21 U.S.C. § 352(o)] because it is not included in a list required by section 510(j) of the Act [21 U.S.C. § 360(j)].

Ocean Cosmeceuticals J Hansyd Hand and Nail (J Hansyd Hand and Nail)

Based on its labeling, J Hansyd Hand and Nail is a topical product used to treat inflamed skin and act as a healing agent for hands, nails and cuticles and is not eligible for the OTC Drug Review. In addition, this drug product violates various provisions of the Act.

The labeling for J Hansyd Hand and Nail does not list the product's active ingredient(s). However, the labeling lists "Ingredients" and they are as follows:

"Water, Helianthus Annuus (Sunflower) Seed Oil, Cetearyl Alcohol, Ceteareth-20, Triticum Vulgare (Wheat) Germ Extract, Glycerin, Mangifera Indica (Mango) Seed Butter, Butyrospermum Parakii (Shea Butter), Niacinamide, Arctium Majus Root Extract, Saccharomyces/Copper Ferment (and) Saccharomyces Manganese Ferment (and) Saccharomyces Zinc Ferment, Saccharomyces Calcium Ferment, Yeast Extract, Camellia Sinensis Leaf Extract, Algae Extract, Ruscus Aculeatus Root Extract, Sodium Hyaluronate (and) Hydrolyzed Glycosaminoglycans, Honey, Sorbitol (and) Yeast Extract, Saccharide Isomerate, Ascorbyl Palmitate, Ceramide 3 (and) Ceramide 6 (and) Ceramide 1 (and) Phytosphingosine (and) Cholesterol (and) Sodium Lauroyl Lactylate (and) Carbomer (and) Xanthan Gum, Threonine, Astaxanthin, Leuconostoc/Radish Root Ferment Filtrate, Phenoxyethanol (and) Iodopropynyl Butylcarbamate, Fragrance."

The product labeling describes the product's intended use. For example, the online brochure (www.mwlabs.com/Book2/view book.html) for this product states:

"Antioxidant, anti-inflammatory and healing agents will help reduce the effects of environmental stresses to the skin"

Based on the labeling described above, J Hansyd Hand and Nail is a "drug" as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because it is intended to affect the structure or function of the body of man. However, we are not aware of sufficient evidence that shows J Hansyd Hand and Nail is generally recognized as safe and effective for its labeled uses. Nor are we aware of any evidence that a product so formulated and labeled was marketed in the United States on or before the inception of the OTC Drug Review; therefore, J Hansyd Hand and Nail does not qualify for evaluation under the ongoing OTC Drug Review. For these reasons, J Hansyd Hand and Nail is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)] and may not be legally marketed in the United States without an approved application under section 505(a) of the Act [21 U.S.C. § 355(a)]. Your product does not have an approved application.

In evaluating the regulatory status of this product, we considered that the labeling does not differentiate between the active and inactive ingredients. Therefore, it is our position that the components listed above as "Ingredients" for J Hansyd Hand and Nail are all active ingredients. Under 21 C.F.R. § 201.66(b)(2) any component in a drug that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans, would be considered an active ingredient.

J Hansyd Hand and Nail is further misbranded under section 502(c) of the Act [21 U.S.C.§ 352(c)] because the product does not bear labeling in accordance with 21 C.F.R. § 201.66. For instance, your product's labeling lacks a "Drug Facts" panel. Additionally, J Hansyd Hand and Nail is misbranded under section 502(e)(1)(A)(ii) of the Act [21 U.S.C. § 352(e)(1)(A)(ii)] because it fails to distinguish between its active and inactive ingredients.

In addition to the above violations, J Hansyd Hand and Nail is misbranded under section 502(o) of the Act [21 U.S.C. § 352(o)] because it is not included in a list required by section 510(j) of the Act [21 U.S.C. § 360(j)]. You must file with the Secretary a list of all drugs which are being manufactured for commercial distribution.

CGMP Charges

In addition, the inspection documented numerous deviations from current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (Title 21, Code of Federal Regulations, Parts 210 and 211) in the manufacturing of OTC drug products, which include your INFLAMMATION RX product line Acne Care Serum, Deep Pain Care Hot, Deep Pain Care Cold, Protection Lotion, Scratch Stopper, and Post Op Lotion. These deviations cause your drug products to be adulterated within the meaning of Section 501 (a)(2)(B) [21 U.S.C. § 351(a)(2)(B)] of the Act in that the manufacture, processing, and holding of drugs do not conform with CGMP regulations to assure that such drugs meet the requirements of the Act as to safety, and have the identity and strength and meet the quality and purity characteristics that they purport or are represented to possess.

The CGMP deviations observed during the inspection include, but are not limited to, the following:

1. Failure to provide adequate laboratory facilities for the testing and approval or rejection of components, drug product containers, closures, packaging materials, in-process materials, and drug products [21 CFR § 211.22(b)]; failure to approve or reject all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product [21 CFR § 211.22(c)]; and failure to establish written procedures applicable to the quality control unit (QCU) [21 CFR § 211.22(d)]. Regarding § 211.22(b), you are responsible for ensuring that the QCU is provided adequate laboratory facilities for sampling and testing of components, containers and closures, in-process materials, and drug products. Your QCU does not have laboratory facilities or a contract with any outside laboratory to conduct such activities. Regarding § 211.22(c), your QCU allows the manufacture and release of drug products without having established procedures addressing, for example, the cleaning and maintenance of equipment, packaging and labeling controls, and warehousing and distribution of drug products.

Regarding § 211.22(d), you lack written procedures applicable to the QCU to include: approval or reject of components, container and closures, in-process and packaging materials, and drug products; laboratory controls; and production and process controls.

2. Failure to test each component for conformity with all appropriate written specifications, or failure to perform an identity test and verify the reliability of the suppliers' report of analysis [21 CFR § 211.84(d)(1) and (2)]; and failure to test each lot of a component for microbiological contamination that is objectionable in view of its intended use [21 CFR § 211.84(d)(6)]. Regarding § 211.84(d)(1) and (2), your firm does not conduct testing (e.g. identification, assay, purity) to show that components are acceptable for drug use or to validate your component supplier's test results. Regarding § 211.84(d)(6), your QCU does not analyze water, used as a major component of your drug products, for microbial contamination.

3. Failure to test each batch of drug product for satisfactory conformance to final specifications, including the identity and strength of each active ingredient, prior to release [21 CFR § 211.165(a)]; and failure to conduct appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms [21 CFR § 211.165(b)]. Regarding § 211.165(a), your QCU does not conduct testing to determine the identity, purity, and strength of your drug product's active ingredients. Regarding § 211.165(b), your QCU has not tested your drug products for microbiological quality over the last two years although water is a major component of your drug formulations.

4. Failure to assure all drug products meet applicable standards of identity, strength, quality, and purity at the time of use by establishing an expiration date determined by appropriate stability testing as described in § 211.166 [21 CFR§ 211.137(a)]. Your firm assigns a 2-year expiration date to your drug products arbitrarily and does not have information or data to support a 2-year expiry on any of your drug products.

5. Failure to prepare complete batch production and control records for each batch of drug product produced [21 CFR § 211.188(b)]. Since December 2006, your batch production records do not include: the identity of individual major equipment and lines used, specific identification of each batch of component used, inspection of the packaging and labeling area before and after use, statement of actual yield and percentage of theoretical yield, complete labeling control records, description of drug product containers and closures, sampling performed, in-process and laboratory control results, and identification of person(s) performing and directly supervising each step.

6. Failure of laboratory controls to include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity [21 CFR § 211.160(b)]. For example, although your firm has attempted to establish a library of infrared (IR) spectra for raw materials and drug products, the IR spectra are inadequate to make a determination of conformance to specifications because the IR spectra do not show any characteristics that can be attributed to the drug (i.e., spectra show flat straight lines). In addition, you failed to demonstrate that the IR spectrometer is calibrated for its intended use.

You did not provide a written response to the Form FDA 483. Finally, during the December 2008 inspection, you agreed to stop marketing the following Inflammation Rx products that are unapproved new drugs and misbranded:

Inflammation Rx Medi-Mist
Inflammation Rx Deep Protection Pre-Sports
Inflammation Rx Eye Recovery
Inflammation Rx Platinum Elite Face Cream
Inflammation Rx AHA/BHA 10% Nano Salicylic Toner
Inflammation Rx After Injectable
Inflammation Rx Skin Fit Lotion
Inflammation Rx Topical Detox

However, it appears that you are still marketing these products. As late as December 2, 2009, we observed your website (http://www.mwlabs.com/Book1/view book.html) and found labeling and other promotional material for these violative products.

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending new drug applications listing your facility as a manufacturer until the above violations are corrected. A reinspection may be necessary.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you no longer manufacture or market any of your drug products, your response should so indicate, including the reasons for, and the date on which, you ceased production.

Your reply should be sent to the following address: Food and Drug Administration, 60 Eighth Street N.E., Atlanta, Georgia 30309, Attention Philip S. Campbell, Compliance Officer. If you have any questions regarding this letter, please contact Mr. Campbell, at (404) 253-1280. You can find guidance and information regarding regulations through links at FDA's Internet website at http://www.fda.gov/oc/industry.

Sincerely yours,

/s/

Anne P. Reid, Acting Director
Atlanta District

 

 

cc. (b)(4)


1.For your information, under the OTC Drug Review, the agency is evaluating the safety and effectiveness of OTC external analgesics, which include those for "temporary relief of minor aches and pains of muscles and joints.... associated with backache, arthritis strains, bruises and sprains." To be covered by that Review, a product's formulation, labeling, dosage form, and method of application must have existed in the OTC drug market place in the United States prior to the inception of the Review or the product must be formulated and labeled consistent with a TFM. Through the Review, FDA published a tentative final monograph (TFM) for OTC External Analgesic Products, in the Federal Register (FR) of February 8, 1983 (48 FR 5867). This TFM is available on FDA's Internet Web site at:
http://www.fda.gov/Drugs/DevelopmentApprovalProccss/DevelopmentResoures/Ovcr-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm155846.htm. Pending a final monograph/rule, the agency does not object to the marketing of products that meet both the formulation and labeling requirements described in this TFM. Such marketing, however, is subject to the risk that a final rule may require reformulation and/or relabeling or FDA approval through the "new drug" procedures in section 505 of the Act (21 U.S.C.§ 355).