U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. R-Garden LLC - 591065 - 02/05/2020
  1. Warning Letters

WARNING LETTER

R-Garden LLC MARCS-CMS 591065 —


Delivery Method:
Overnight Delivery

Recipient:
Recipient Name
Donald L. Smyth
Recipient Title
President
R-Garden LLC

(b)(6)
United States

Issuing Office:
Division of Human and Animal Food Operations West VI

United States


February 5, 2020

In reply, refer to: CMS 591065

 

WARNING LETTER

Dear Mr. Smyth:

The U.S. Food and Drug Administration conducted an inspection of your facility, located at (b)(6), on August 5, 2019, through August 15, 2019. Based on the inspection, we have identified serious violations of the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.

In addition, FDA reviewed your labels and labeling, including monthly newsletters that you provide with customer orders, your product catalog, and your website, www.rgarden.com, where you take orders for your products. Based on our review, the claims on your website and promotional materials for your products including, but not limited to, Vitamin O, Gamma-Zyme, L. Salivarius, Vitamin B-12, Colloidal Silver, Protease Plus, Sun Energy, Cordyceps, Cordyceps Plus, Amylase Formula, Lipase Formula, Maximizer, and Quadra-Zyme Plus products establish that they are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products into interstate commerce for such uses violates the Act.

We have also reviewed the product labels for your Vitamin O, Protease Plus, Sun Energy, Maximizer, Multi-Vitamin Plus, Resveratrol Complex, CoQ-10 Formula, Gamma-Zyme, and Colloidal Silver products. Based on our review, we have concluded these products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].

You may find the Act and related regulations through links in FDA’s home page at www.fda.gov.

We received letters from you dated August 21, 2019, and October 14, 2019, written in response to the Form FDA 483, Inspectional Observations, issued to you at the close of the inspection. We address your responses below, in relation to the adulterated dietary supplements violations.

Unapproved New Drugs and Misbranded Drugs

During the inspection, our investigator collected labeling for your dietary supplements, including your product catalog, R-Garden Products for Your Path to Health, and your monthly newsletters, which are included with your customer orders. In addition, we have reviewed your website, www.rgarden.com in October 2019, and again in February 2020, and have determined you take orders there for your products, including Vitamin O, Gamma-Zyme, L. Salivarius, Vitamin B-12, Protease Plus, Sun Energy, Cordyceps, Cordyceps Plus, Amylase Formula, Lipase Formula, Maximizer, and Quadra-Zyme Plus. The claims on your labeling, including your website, product catalog, and newsletters, establish that these products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.

Examples of claims on your website www.rgarden.com and promotional materials that provide evidence these products are intended for use as drugs include, but are not limited to:

Protease Plus

• R-Garden Products for Your Path to Health product catalog: “Protease is believed to be helpful for relieving fever, infection, colds, flu, sore throat, parasites, candida, . . . depression, anxiety, . . . and insomnia”.

• R-Garden Newsletter, August 2019: “Protease Plus . . . can be of tremendous help when dealing with the toxins and bacteria that are circulating in the blood stream when fever, infections, colds, sore throat, parasites . . . depression, anxiety, or insomnia are present . . . a well-known and respected alternative cancer doctor based in New York City, used proteolytic enzymes extensively in treating cancer.”

• From the web page “Protease Plus” on your website www.rgarden.com: “Protease Plus also can be of tremendous help when dealing with the toxins and bacteria that are circulating in the blood stream.”

Sun Energy

• R-Garden Products for Your Path to Health product catalog:

     o “Studies have shown that [ingredient in the product] chlorella . . . help[s] to negate the effects of chemotherapy and radiation, lowering blood pressure and cholesterol”.

     o “[Ingredient in the product] Spirulina . . . leav[es] the person less likely to experience colds, flus, and other contractible illnesses.”

• From the web page “Sun Energy” on your website www.rgarden.com:

     o “Studies have shown that [ingredient in the product] chlorella . . . help[s] to negate the effects of chemotherapy and radiation”.

     o “[Ingredient in the product] Spirulina . . . leav[es] the person less likely to experience colds, flus, and other contractible illnesses.”

L. Salivarius

• R-Garden Products for Your Path to Health product catalog: “[L. Salivarius] is believed to be useful. . . for fighting the distress caused by food poisoning, for help with flu-like symptoms. . .”

• From the web page “L. Salivarius Technical Information” on your website www.rgarden.com:

     o “Diverticula of the Small Intestine: . . . The presence of L. Salivarius in the small intestine could very rapidly eliminate any toxic symptoms associated with this condition.”

     o “Diverticula of the colon: . . . This accumulation [of fecal material] is common in colon diverticula and is responsible for diverticulosis and many other serious complications . . . L. Salivarius . . . can be an effective help for ridding these diverticula pockets of their  toxic contents.”

Cordyceps and Cordyceps Plus

• R-Garden Newsletter, June 2019:

     o “. . . anti-inflammatory and antispasmodic properties of the herb [cordyceps] which can prevent heart arrhythmias and other complications.”

     o “[Cordyceps] is beneficial for those suffering from . . . asthma or chronic bronchitis.”

     o “Cordyceps directly stimulates the production of NK cells (Natural Killer cells), which are one of the body's first lines of defense against infection and illness. These immunoprotective effects help with a wide range of ailments, from cancer to the common cold and everything in between.”

     o “Some of the most interesting health benefits of cordyceps includes its ability to . . . prevent certain types of cancer”.

Gamma-Zyme

• From the web page “Gamma-Zyme” on your website www.rgarden.com: “[ingredient in the product] Ferulic acid appears to provide health benefits due to its ability to prevent abnormal tissue growth”.

• R-Garden Products for Your Path to Health product catalog: “Gamma-Zyme is a soothing alternative for those suffering from ulcers, gastritis, severe burning sensations, irritable bowel syndrome, or intestinal lining damage.”

Vitamin B-12

• R-Garden Products for Your Path to Health product catalog: “Reduces the risk of age-related brain and heart diseases, including Alzheimer’s.”

Amylase Formula, Lipase Formula, Protease Plus, Maximizer, Quadra-Zyme Plus, and Gamma-Zyme

• R-Garden Newsletter, August 2019: “What is the Purpose of Enzymes? . . . European doctors have had significant success in stopping early onset cancer by oral supplementation of enzymes . . . Works Better Then Chemotherapy! . . . oral enzymes taken with chemotherapy and radiation improves the response rate and reduces the side effects significantly . . . tests of patients who had problems with blood clots. 93% of the patients significantly improved after enzyme treatments . . . Better That [sic] Drugs For Shingles! . . . R-Garden has three different individual enzyme formulas – Amylase Formula, Lipase Formula and Protease Plus . . . Maximizer, Quadra-Zyme Plus, and Gamma-Zyme are our multiple enzyme formulas.”

Colloidal Silver

• R-Garden Products for Your Path to Health product catalog: “[Colloidal Silver] may be taken orally or applied topically to cuts, scrapes, open sores, sunburned skin . . .”

Your July 2019, R-Garden Newsletter labeling also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your Vitamin O product for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

• “Three years ago they said that I’m starting to get cataracts, so l put a drop of Vitamin O in each eye at bedtime. Now two weeks ago when I got my eyes checked they said nothing about cataracts."

• "I like your Vitamin O. I've had a headache where painkillers didn't seem to help much. I rubbed Vitamin O in and it did wonders. l also like to use it for colds. Baby had a cold so we took him to the doctor. His oxygen was reading in the upper 70's and into 80's so they sent us on to Urgent Care. On the way up I gave him some of your Vitamin O. When we got there and checked his oxygen it was 98.”

• “The Vitamin O stopped my husband’s sleep apnea.”

In addition, your Vitamin O, Gamma-Zyme, L. Salivarius, Vitamin B-12, Colloidal Silver, Protease Plus, Sun Energy, Cordyceps, Cordyceps Plus, Amylase Formula, Lipase Formula, Maximizer, and Quadra-Zyme Plus products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

Further, a drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” mean directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your Vitamin O, Vitamin B-12, Protease Plus, Sun Energy, Cordyceps, Cordyceps Plus, Gamma-Zyme, Amylase Formula, Lipase Formula, Maximizer, and Quadra-Zyme Plus are intended for the treatment of one or more diseases that are not amenable to selfdiagnosis
or treatment without supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use these products safely for their intended purposes. Accordingly, these products failed to bear adequate directions for their intended uses and, therefore, these products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].

Furthermore, according to 21 CFR 310.548, any over-the-counter drug product containing colloidal silver ingredients that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a “new drug” within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] for which an approved application is required for marketing, without which such product is also misbranded under section 502 of the Act [21 U.S.C. § 352].

Adulterated Dietary Supplements

Even if your products listed above did not have therapeutic claims that make them unapproved new drugs, these products would be adulterated dietary supplements under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements:

1. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, during the inspection it was observed that you lack written procedures for quality control operations, including for documentation of how you qualify your (b)(4) manufacturers, approve formulations and labels, and release product for distribution.

You failed to have quality control operations to approve for release, or reject, any packaged and labeled dietary supplements (including a repackaged or relabeled dietary supplement) for distribution, as required by 21 CFR 111.127(h). Once quality control procedures are established, you must make and keep records, as required by 21 CFR 111.140(b).

We acknowledge your written responses dated August 21, 2019, and October 14, 2019. In your first response, you state that you will complete written procedures for quality control operations for your firm and that you will provide them to us in three weeks. Your second written response includes your (b)(4) manufacturer’s written procedures for quality control operations for the (b)(4) they manufacture for you. However, you only provided a copy of your (b)(4) manufacturer’s quality control check for (b)(4) and not a copy of your own firm’s written procedures for quality control.

2. You failed to establish specifications for dietary supplement labels (label specifications), as required by 21 CFR 111.70(d). During the inspection you stated that although you design the labels, have them printed, approve them after printing, and send the finished and approved dietary supplement labels to your (b)(4) manufacturer, you do not have label specifications for your dietary supplement products, including your Vitamin O product.

We acknowledge your written response dated August 21, 2019, which states that you will create label specifications within eight weeks. However, we are unable to evaluate the adequacy of the corrections because the label specifications have not yet been provided.

Misbranded Dietary Supplements

Even if your products listed above did not have therapeutic claims that make them unapproved new drugs, your products would be misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343] based on the following violations:

1. Your Vitamin O, Protease Plus, Sun Energy, Maximizer, Multi-Vitamin Plus, Resveratrol Complex, CoQ-10 Formula, Gamma-Zyme, Colloidal Silver, L. Salivarius, Vitamin C Complex, and Vitamin D-3 products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36 and 21 CFR 101.9. Specifically:

a. The Vitamin O, Multi-Vitamin Plus, and Protease Plus product labels declare (b)(2)-dietary ingredients as zero or in amounts that are <2% of the Reference Daily Intake (RDI) for the nutrient on the Supplement Facts label. Any (b)(2)-dietary ingredient that is not present or that is present in amounts that can be declared as zero in 21 CFR 101.9(c) must not be declared in accordance with 21 CFR 101.36(b)(2)(i). Specifically:

i. The Vitamin O label lists calories and carbohydrate as zero. Further, the label lists “Trace amounts of: Chloride, Sodium, Calcium, Magnesium, Phosphorus, Copper, and Selenium.” We have not defined “trace amounts.” If these (b)(2) nutrients are present in amounts that can be declared as zero, they must not be declared in the Supplement Facts label. If they are present in amounts greater than can be declared as zero, then they must be declared in accordance with 21 CFR 101.36(b)(2)(i).

ii. Likewise, your Protease Plus product label declares “calcium citrate” by weight and as <1% of the Daily Value (DV). Calcium is a (b)(2) dietary ingredient and must be listed as the amount by weight of the calcium nutrient, not the weight of the source of the nutrient.
However, it must not be listed within the Supplement Facts label if it is present in an amount that can be declared as zero.

iii. The Multi-Vitamin Plus label declares iodine at 1% DV. It must not be listed within the Supplement Facts label if it is present in an amount that can be declared as zero.

b. Your L. Salivarius, Protease Plus, Maximizer, Resveratrol Complex, CoQ-10 Formula, and Gamma-Zyme product labels list incorrect serving sizes. The serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and Table 2 in 21 CFR 101.12(b). However:

i. The L. Salivarius label’s Directions state to take “one or more capsules.” However, the Supplement Facts label lists one capsule as the serving size. In addition, we note that the L. Salivarius product web page on your website www.rgarden.com lists directions to take up to three capsules at a time.

ii. The Protease Plus label’s Directions state to take “one or more capsules.” However, the Supplement Facts label lists one capsule as the serving size. In addition, we note that the Protease Plus product web page on your website www.rgarden.com lists directions to take up to four capsules at a time.

iii. The Maximizer (90, 180, and 360 capsules count) label’s Directions state to take “two or more capsules.” However, the Supplement Facts label lists two capsules as the serving size. In addition, we note that the Maximizer product web page on your website www.rgarden.com lists directions to take up to four capsules at a time.

iv. The Resveratrol Complex label’s Directions state to take “one or more capsules with meals, or as desired.” However, the Supplement Facts label lists one capsule as the serving size. In addition, we note that the Resveratrol Complex product web page on your website www.rgarden.com lists directions to take one or more capsules with meals, or as desired.

v. The CoQ-10 Formula label’s Directions state to take “one or more capsules with meals.” However, the Supplement Facts label lists one capsule as the serving size. In addition, we note that the CoQ-10 Formula product web page on your website www.rgarden.com lists directions to take one or more capsules with meals.

vi. The Gamma-Zyme (100 and 200 capsules count) label’s Directions state to take “one or more capsules.” However, the Supplement Facts label lists one capsule as the serving size. In addition, we note that the Gamma-Zyme product web page on your website www.rgarden.com lists directions to take up to four capsules at a time.

c. The Colloidal Silver product label fails to list the serving size for each of the age groups indicated on the label which includes 1 teaspoon (5 mL) once a day for adults, and for children to take ¼ - ½ teaspoon (1.25 - 2.5 mL) once a day. The product is for persons within two different groups, and the quantitative amount and percent of Daily Value for each group shall be presented in separate columns in accordance with 21 CFR 101.36(b)(2)(iii)(E).

d. Your R-Garden Products for Your Path to Health product catalog bears the nutrient content claim for your Sun Energy product “[ingredients in the product] Wheatgrass sprouts and Barley Grass [are] Naturally rich in a range of important vitamins, minerals, amino acids, phytonutrients and metabolic enzymes.” Vitamins or minerals listed in 21 CFR 101.9(c)(8)(iv) or (c)(9) must be declared if added for purposes of supplementation, or when a claim is made about them in accordance with 21 CFR 101.36(b)(2)(i). However, the Sun Energy Supplement Facts label fails to list any vitamins or minerals.

Further, in order to bear the nutrient content claim, the amounts of nutrients in the product must be sufficient to qualify as a “rich” source of the nutrients, as defined in 21 CFR 101.54(b).

e. Your Multi-Vitamin Plus label declares Vitamin B3 and Vitamin B5, each of which is not the common or usual name for a (b)(2)-dietary ingredient per 21 CFR 101.36 and 101.9(c)(8)(iv)-(v)).

f. Your Vitamin C Complex label appears to be using the DVs and RDIs that existed prior to July 2016; this is permitted until dietary supplement product labels must be compliant with the Nutrition Facts and Supplement Facts label final rule. However, the label fails to declare the correct % DV for potassium and zinc in accordance with 21 CFR 101.36(b)(2)(iii)(C).

g. Your Vitamin D-3 label fails to correctly declare the amount of Vitamin D-3. The amount of Vitamin D may, but is not required to, be expressed in international units (IU), in addition to the mandatory declaration in mcg. Any declaration of the amount of Vitamin D in IU must appear in parentheses after the declaration of the amount of Vitamin D in mcg in accordance with 21 CFR 101.36 and 101.9(c)(8)(iv).

h. The Resveratrol Complex product label bears the statement, “Resvinol is a registered trademark of Ethical Naturals, Inc.” within the Supplement Facts label. This statement is not permitted to be in the Supplement Facts label. 21 CFR 101.36(b). The light bar above this statement is also not permitted.

i. The Vitamin C Complex product’s (b)(2)-dietary ingredients are not listed in the correct order in accordance with 21 CFR 101.36(b)(2)(B). The source for each of the dietary ingredients calcium, magnesium, potassium, and zinc is not declared in accordance with 21 CFR 101.36(d). The source ingredient that supplies a dietary ingredient may be identified within the nutrition label in parentheses immediately following or indented beneath the name of a dietary ingredient and preceded by the words “as” or “from” that is listed on the Supplement Facts label or be listed in the ingredient list.

2. Your Sun Energy product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labeling bears unauthorized nutrient content claims. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.

Specifically, your July 2019, R-Garden Newsletter, which you include with your customer orders, bears the statement, “Sun Energy contains four superfoods high in chlorophyll and rich in many essential nutrients: Chlorella, Spirulina, Wheat Grass and Barley Grass.”

Additionally, your R-Garden Products for Your Path to Health product catalog bears the nutrient content claim, “[ingredients in the product] Wheatgrass sprouts and Barley Grass [are] Naturally rich in a range of important vitamins, minerals, amino acids, phytonutrients and metabolic enzymes.”

“High” and “rich” claims may only be made for nutrients that have an RDI. An RDI has not been established for chlorophyll, amino acids, phytonutrients and metabolic enzymes per 21 CFR 101.13(b) and 21 CFR 101.54(b).

3. Your Herbal Blends Prostate System, Herbal Blends Pancreas System Blend, Herbal Blends Liver Gallbladder System, Gamma-Zyme, EpiCor Formula, Cordyceps Plus, Cordyceps, CoQ-10 Formula, Bowel Toner, Amylase Formula, Advanced Joint Formula, Vitamin D-3, Vitamin C Complex, Sun Energy, Resveratrol Complex, Quadra-Zyme Plus, Protease Plus, Pine Bark Extract, Milk Thistle Formula, Resveratrol Complex, and Memory Formula products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each product label fails to declare the common or usual name of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4.

For example, your Memory Formula, Lion’s Mane is not the standardized common name of a botanical. For your Resveratrol Complex, red wine fruit extract fails to identify the “fruit”. For your Herbal Blends Pancreas System Blend, Triphala is not a standard common name. Several products indicate “rice complex” in the other ingredients list (Herbal Blends Prostate System, Herbal Blends Pancreas System Blend, Herbal Blends Liver Gallbladder System, Gamma-Zyme, EpiCor Formula, Cordyceps Plus, Cordyceps, CoQ-10 Formula, Bowel Toner, Amylase Formula, Advanced Joint Formula, Vitamin D-3, Vitamin C Complex, Sun Energy, Resveratrol Complex, Quadra-Zyme Plus, Protease Plus, Pine Bark Extract, Milk Thistle Formula, Memory Formula); this is not the common or usual name of an ingredient.

4. Your Memory Formula, Herbal Blends Eyes System, Herbal Blends Liver Gallbladder System, Milk Thistle Formula, and Herbal Blends Prostate System products are each misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

For example, for your Memory Formula, Lion’s Mane is missing the plant part. For your Herbal Blends Eyes System, “aerials” are not a specific plant part. For your Herbal Blends Liver Gallbladder System, Horsetail has no plant part and Cleavers “herb” is not a plant part. For your Herbal Blends Pancreas System Blend, the plant part is missing for Horsetail and Broccoli. For your Herbal Blends Prostate System, Horsetail, Basil, and Pygeum africanum are each missing the plant part.

5. The Colloidal Silver products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to correctly declare the net quantity of contents on the principal display panel, as required by 21 CFR 101.7. Specifically, the product label fails to list the net quantity of contents in fluid measure in terms of fluid ounce in accordance with 21 CFR 101.7(b)(2). The net quantity of contents must be expressed in both fluid ounce and metric equivalent as required by the Fair Packaging and Labeling Act [15 U.S.C. § 1453(a)(2)].

This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your products comply with the Act and FDA’s implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct the violations specified above may result in legal action without further notice, including seizure of violative products and/or injunction.

In addition to the violations described above, we offer the following comment:

Your Vitamin O and Colloidal Silver products, although labeled as dietary supplements, are also intended for use as topical sprays on the skin or for other topical uses as described in your product catalog and in the customer testimonials in your July 2019, R-Garden
Newsletter. Under section 201(ff)(2)(A)(i) of the Act [21 U.S.C. § 321(ff)(2)(A)(i)], the term “dietary supplement” is defined as, among other things, a product “intended for ingestion.” Products that are intended to be used topically or introduced into the body other than through ingestion are not dietary supplements because they are not “intended for ingestion.”

Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

Please notify this office in writing within fifteen (15) business days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington, 98021, to the attention of Tracy K. Li, Compliance Officer.  If you have any questions concerning this letter, you can contact Ms. Li at (425) 302-0428.  

 

Sincerely,

/S/
Miriam R. Burbach
District Director
Program Division Director

 
cc:
Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560