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WARNING LETTER

Essential Pharmaceutical Corp MARCS-CMS 597677 —

Delivery Method:
United Parcel Service
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Dr. Bruce Y. Lin
Recipient Title
President
Essential Pharmaceutical Corp

1906 W. Holt Ave
Pomona, CA 91768-3351
United States

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

United States

WARNING LETTER

September 3, 2020

WL # 597677

Dear Dr. Lin:

The United States Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility, Essential Pharmaceutical Corp, located at 1906 W. Holt Ave, Pomona, CA, on October 8-10 and 17, 2019. Based on the inspectional findings and a subsequent review of your product labels collected during the inspection, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

Unapproved New Drug

Your firm manufactures and distributes “BIO-MINT Nasal Spray,” which is an unapproved new drug and is being marketed as a nonprescription, over-the-counter (OTC) drug product. Introduction or delivery for introduction of such product into interstate commerce is prohibited under sections 505(a) and 301(d) of the Act, 21 U.S.C. 331(d) and 355(a). This product is also misbranded under section 502(ee) of the Act, 21 U.S.C. 352(ee), and its introduction into interstate commerce is prohibited by section 301(a) of the Act, 21 U.S.C. 331(a). These violations are described in more detail below.

“BIO-MINT Nasal Spray” is a drug under section 201(g)(1)(B) of the Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as a combination nasal decongestant, antihistamine, and antiseptic.

Examples of claims observed on the product label that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product include, but may not be limited to, the following:

    • “Nasal Decongestant Antihistamine Antiseptic . . .● Allergies ● Colds ● Hay Fever ● Sinusitis . . . For prompt, temporary relief of nasal congestion due to colds, sinusitis hay fever, allergies and runny nose.”

For the reasons explained below, BIO MINT Nasal Spray is also a new drug within the meaning of section 201(p) of the Act, 21 U.S.C. 321(p), and requires an approved new drug application under section 505 of the FD&C Act, 21 U.S.C. 355, in order to be introduced or delivered for introduction into interstate commerce.

A drug that is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling is a new drug within the meaning of section 201(p) of the Act, 21 U.S.C. 321(p). We are unaware of any adequate and well-controlled clinical studies in the published literature that support a determination that BIO-MINT Nasal Spray is GRASE for use under the conditions suggested, recommended, or prescribed in its labeling, including the above-described intended uses; absent this evidence, the product is not GRASE. Nor is the new drug status of BIO-MINT Nasal Spray altered by section 505G of the Act, 21 U.S.C. 355h,1 because the product does not satisfy the conditions under 505G(a)(1) of the Act that would make it a drug deemed to be GRASE and not a "new drug".

According to its labeling, “BIO-MINT Nasal Spray” is a drug for topical (nasal) administration that contains as active ingredients the nasal decongestant phenylephrine HCL, the antihistamine pyrilamine maleate, and the antiseptic benzalkonium chloride. This drug does not satisfy the requirements of either section 505G(a)(1)(A) or section 505G(a)(1)(B) of the Act.

Under section 505G(a)(1)(A) of the Act, in order for a nonprescription drug to be deemed to be GRASE and not a new drug, it must be in conformity with the requirements of a final monograph issued under 21 CFR part 330 and other applicable requirements. Although FDA issued a final monograph under 21 CFR part 330 for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use that provides requirements for nonprescription topical nasal decongestant and antihistamine drug products (see 21 CFR Part 341),2 BIO-MINT Nasal Spray is not in conformity with these requirements because that final monograph does not permit the combination of an antihistamine active ingredient with a nasal decongestant active ingredient in a topical dosage form. Similarly, the final monograph does not permit the combination of a nasal decongestant active ingredient with an antiseptic active ingredient such as benzalkonium chloride. (See 21 CFR 341.40).

Nor is BIO-MINT Nasal Spray deemed to be GRASE and not a new drug under 505G(a)(1)(B) of the Act, which accords that status to a drug that is classified in category I for safety and effectiveness under a tentative final monograph that is the most recently applicable proposal or determination issued under 21 CFR part 330, if that drug is in conformity with the proposed requirements for nonprescription use of such tentative final monograph and any applicable subsequent determination by the Secretary, and conforms with other applicable requirements. Although nonprescription drug products that contain benzalkonium chloride and that are intended for use as topical antiseptics were addressed in the Tentative Final Monograph (TFM) for OTC Topical Antimicrobial Products, 43 FR 1210 (January 6, 1978) (amended at 56 FR 33644 (July 22, 1991) (addressing first aid antiseptics) and 59 FR 31402 (June 17, 1994), 78 FR 76444 (December 17, 2013), 80 FR 25166 (May 1, 2015), and 81 FR 42912 (June 30, 2016) (addressing consumer and health care antiseptics)), these documents do not classify into category I any drug that includes the combination of an antiseptic, an antihistamine, and a nasal decongestant active ingredient.

For the foregoing reasons, “BIO-MINT Nasal Spray” is a new drug within the meaning of section 201(p) of the Act, 21 U.S.C. 321(p) and it may not be legally marketed in the United States absent approval of an application filed in accordance with section 505(a) of the Act, 21 U.S.C. 355(a).3 “BIO-MINT Nasal Spray” is not the subject of an FDA-approved application, and its introduction or delivery for introduction into interstate commerce is prohibited under sections 505(a) and 301(d) of the Act, 21 U.S.C. 355(a) and 331(d). In addition, because “BIO-Mint Nasal Spray” is a nonprescription drug that is subject to section 505G of the Act, is not the subject of an application approved under section 505 of the Act, and does not comply with the requirements under section 505G of the Act, it is misbranded under section 502(ee) of the Act, 21 U.S.C. 352(ee), and its introduction into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. 331(a).

Adulterated Dietary Supplements

The inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the products you manufacture 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 they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.

The significant violations documented during the inspection include, but are not limited to, the following:

1. You failed to establish specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b). Specifically,

a. You failed to establish identity specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1).
b. You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2).
c. You failed to establish limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(3).

For example, you failed to establish specifications for the following components:

a. D‐Biotin Lot (b)(4) component for Vicare brand DiabeCare Lot (b)(4) product
b. Bitter Melon Extract Lot (b)(4) component for Vicare brand DiabeCare Lot (b)(4) product
c. Suprarenal Substance Lot (b)(4) component for Lakeway Essentials brand Immune Support Lot (b)(4) product
d. Radix Notoginseng (no lot #) component for GC Naturals brand CSDP Gold Lot (b)(4) product
e. Bee Pollen Powder Lot (b)(4) component for Lakeway Essentials brand Immune Support Lot (b)(4) product
f. Placenta Substance Lot (b)(4) component for Lakeway Essentials brand Immune Support Lot (b)(4) product
g. Ascorbic Acid Lot (b)(4) component for Lakeway Essentials brand Immune Support Lot (b)(4) product

Once you have established component specifications and before using a component, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i), unless you petition the agency under 21 CFR 111.75(a)(1)(ii) and the agency exempts you from such testing. You must also confirm the identity of other components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2).

We acknowledge that you have established specifications for microbiological contaminants for your dietary ingredients and other ingredient components. During the inspection, you stated that your microbiological contaminants specifications are your identity specifications. These specifications are not considered identity specifications. They would be considered to be a type of contamination specification only. In addition, while you established specifications for microbial contaminants for your dietary ingredients and other ingredient components, you failed to establish limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement, for example specifications for heavy metal contamination.

Further, you have been conducting testing on some of your incoming ingredients using FTIR. However, you have not established an identity specification to ensure that the results are evaluated against a valid standard. Your FTIR testing compares the in-coming component to previously received lots of the component. The previously received lots have not been qualified as reference standards.

2. You failed to establish product specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you list “(b)(4)” as the specification for your finished products. “(b)(4)” is not a finished product specification; it is an in-process control. For example, the following products list “(b)(4)” as a finished product specification:

    • Vicare brand DiabeCare
    • Lakeway Essentials brand Immune Support
    • GC Naturals brand CSDP Gold

Once you have established the appropriate specifications you must determine whether the specifications are met in accordance with 21 CFR 111.75.

3. You failed to establish specifications for dietary supplement labels, as required by 21 CFR 111.70(d). Specifically, you receive and apply labels for some of the products that you contract manufacture, including Vicare brand DiabeCare, Lakeway Essentials brand Immune Support, and GC Naturals brand CSDP Gold. You have not established label specifications with which to compare incoming labels.

4. You failed to establish and follow all required 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 reprocessing as required by 21 CFR 111.103. Specifically, you have not established written procedures for the responsibilities of your quality control operations for the following:

a. Your quality control (b)(4) did not ensure that the dietary supplement is labeled as specified in the master manufacturing record as required by 21 CFR 111.105. Specifically, your quality control (b)(4) conducted a material review and made a disposition decision to ensure that the finished dietary supplement Vicare brand DiabeCare, lot (b)(4) was labeled per Master Manufacturing Record; however, ingredients included in the MMR and in the BPR were not all listed on the label.
b. Your quality control (b)(4) did not approve or reject processes, specifications, written procedures, controls, tests, examinations and deviations or modifications that may affect the identity, purity, strength, or composition of a dietary supplement as required by 21 CFR 111.105. Specifically, your quality control (b)(4) are not conducting and documenting the following required quality control operations:

1) A material review and disposition decision of the microbiology analysis conducted for components and finished dietary supplements.
2) A material review and disposition decision of reject, rework, or approve for components prior to use.
3) Documentation of a disposition decision of each finished dietary supplement batch, including all batch‐related records. Quality Control personnel only document that the batch production record has been reviewed. An example of such finished product is Vicare brand DiabeCare Lot (b)(4).
4) A material review, then signature and date upon implementation of all written procedures. You do not have a written procedure for quality control operations, holding and distribution operations, receiving operations, handling returned dietary supplements, equipment maintenance, quarantine system, production and process control operations, and packaging and labeling operations. Examples of unapproved written procedures are your (b)(4) SOP, (b)(4) SOP, and your (b)(4) SOP.

c. Your quality control (b)(4) did not reject a dietary supplement when an established microbiological specification was not met as required by 21 CFR 111.113(b)(2). Specifically, your quality control (b)(4) do not reject a finished dietary supplement batch when microbiological specifications are not met. For example, your dietary supplement GC Naturals brand CSDP Gold Lot (b)(4) did not meet established specifications for Total Aerobic Count (TAC), Yeast & Mold, Enterobacteria, and E. coli. You distributed the finished dietary supplement batch to your customer on 01/22/19 and 02/08/19.
d. Your quality control operations did not include approving or rejecting reprocessing when a microbiological specification was not met, as required by 21 CFR 111.123(a)(5). Specifically, your quality control (b)(4) do not conduct and document a material review and disposition decision approving or rejecting the reconditioning treatment conducted for dietary ingredients and finished dietary supplements that do not meet established microbiology specifications. For example, your dietary ingredient Bee Pollen Powder Lot (b)(4) (used to make the dietary supplement Lakeway Essentials brand Immune Support Lot (b)(4)) and your dietary supplement product GC Naturals brand CSDP Gold Lot (b)(4) did not meet established specifications for Total Aerobic Count (TAC) and Staphylococcus Aureus. In both cases, you told the investigator that you (b)(4).

5. You failed to prepare a Master Manufacturing Records (MMRs) that includes the information specified in 21 CFR 111.210. Specifically, your MMRs for the dietary supplement products you contract manufacture, including Vicare brand DiabeCare, Lakeway Essentials brand Immune Support, and GC Natural brand CSDP Gold, do not include the following:

a. A complete list of components to be used as required by 21 CFR 111.210(b). Specifically, our inspector identified handwritten formulation adjustments that are documented on the batch production record to include components not listed in the MMR formulation.
b. An accurate weight or measure for each component as required by 21 CFR 111.210(c). Specifically, our inspector identified handwritten formulation adjustments are documented on the batch production record to add a component and component amount as well as to change an existing component strength or amount not listed in the MMR.
c. A statement of the theoretical yield for each point, step, or stage of the manufacturing process to ensure quality control or the expected yield of the finished dietary supplement as required by 21 CFR 111.210(f).
d. A description of packaging and a representative label or a cross-reference to the physical location of the actual or representative label as required by 21 CFR 111.210(g).
e. Specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement as required by 21 CFR 111.210(h)(1). Your MMRs lack written instructions for time required for blending.
f. Procedures for sampling as required by 21 CFR 111.210(h)(2). Your MMRs lack written instructions for in-process testing frequency and for the amount of product to be collected by Quality Control for sampling.
g. Written instructions for one person adding a component and another person verifying the addition of the component as required by 21 CFR 111.210(h)(3)(ii)(B).
h. Corrective action plans for use when each specification is not met as required by 21 CFR 111.210(h)(5).

6. You failed to prepare a batch production record every time you manufactured a batch of dietary supplements with the information required by 21 CFR 111.255(b). Specifically, your batch production records for Vicare brand DiabeCare Lot (b)(4), Lakeway Essentials brand Immune Support Lot (b)(4), and GC Natural brand CSDP Gold Lot (b)(4), do not include the following required information:

a. The actual weight or measure of each component used (21 CFR 111.260(e)).
b. The time of cleaning and sanitizing of each piece of equipment (21 CFR 111.260(c)).
c. The unique identifier that you assign to each packaging component and label used (21 CFR 111.260(d)).
d. A statement of actual yield obtained at appropriate phases of processing, such as after blending and after encapsulation (21 CFR 111.260(f)).
e. The initials of the person verifying the weight of each component (21 CFR 111.260(j)(2)(ii)).
f. An actual or representative label, or a cross-reference to the physical location of the actual or representative label for the finished dietary supplement for all batches (21 CFR 111.260(k)(2)).

We note that you document the equipment used in the BPR. However, as you have multiple pieces of equipment with the same identification in different rooms, documenting the room in which the processing takes place would clarify which of the same named equipment was used.

7. You did not maintain, clean and sanitize equipment, and contact surfaces used to manufacture or hold components or dietary supplements as required by 21 CFR 111.27(d). Specifically,

a. Per your undated (b)(4) SOP, the (b)(4) machines are to be partially disassembled and cleaned with water and Isopropyl Alcohol. Any machine thus cleaned are to be recleaned if not used within three (3) days. (b)(4) Machine 3 located in (b)(4) Room 1 was observed to have chipped paint and a yellow powder buildup. This Machine was verbally identified as being cleaned and ready for use.
b. Blender 2 was observed to be stored with yellow powder build up from a previous use of the machine and had just had a product that was off-white blenblended in it. Further, the corners and top surface of the machine are not smooth or easily cleanable.
c. Additionally, several of the (b)(4) machines located in (b)(4) Room 1 were identified as not being able to be disassembled for cleaning. Further, our investigators were told that it takes approximately (b)(4) hours to completely disassemble and clean a (b)(4) machine but that only (b)(4) minutes are allotted for cleaning between products (b)(4) through (b)(4) and (b)(4) minutes on (b)(4). We were advised that the (b)(4)-minute cleaning allowed for a blow down of equipment followed by a wipe with water and finally a spray with isopropyl alcohol.
d. Finally, several of the (b)(4) machines located in (b)(4) Room 1 had tape, rope/twine, and cardboard, etc. affixed to the machines. These materials are not easily cleanable.

Misbranded Dietary Supplements

The dietary supplement products discussed below are misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Act and/or fail to comply with the regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101.

1. Your products, Vicare brand DiabeCare, Lakeway Essentials brand Immune Boost, and GC Naturals brand CSDP Gold, are misbranded within the meaning of section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example:

a. Vicare brand DiabeCare, lot (b)(4), was manufactured using the components Potassium Sorbate and Lodex-10, but the label fails to list the common or usual names of these components. Furthermore, the label declares the ingredients gelatin and microcrystalline cellulose, but these ingredients do not appear on the batch record for lot (b)(4). Lastly, the Gymnema Sylvestre extract listed on the label is “(b)(4)%” and the Gymnema Sylvestre used to manufacture the lot is “(b)(4)%.”
b. The Vicare brand DiabeCare product label declares the dietary ingredient banaba. This botanical is not listed in the reference Herbs of Commerce; therefore, the product label must state the Latin binomial name of the plant in accordance with 21 CFR 101.4(h)(2).
c. Lakeway Essentials brand Immune Boost, lot (b)(4), was manufactured using the components Krafen, DCP unmilled, Sipernate-22, Sodium Croscarmellose, Folic Acid, Vitamin B-12, and Fumarate, but the label fails to list the common or usual names of these components. Furthermore, the label fails to state the source of the glandular materials.
d. GC Naturals brand CSDP Gold, lot (b)(4), was manufactured with Magnesium Stearate, Tixosil-38A and Potassium Sorbate, but the label fails to list the common or usual names of these components.

2. Your product, Lakeway Essentials brand Immune Boost, lot (b)(4), is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product is falsely labeled to contain Lymph Tissue and Bone Marrow but, according to the BPR, these components were not included during manufacture.

3. Your product, Lakeway Essentials brand Immune Boost, is misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that the label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

4. Your products, Vicare brand DiabeCare and Lakeway Essentials brand Immune Boost, are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. 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 21 CFR 101.12(b) Table 2.
a. The Vicare brand DiabeCare product’s Supplement Facts label indicates a serving size of 2 capsules; however, the “Suggested Usage” states “take one capsule after each meal.” The serving size should be 1 capsule.
b. The Lakeway Essentials brand Immune Boost product’s Supplement Facts label indicates a serving size of 2 capsules; however, the “Directions” state “… 2-6 tablets per day ….” The serving size should be 6 tablets.

5. Your products, Vicare brand DiabeCare and Lakeway Essentials brand Immune Boost, are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail 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: Bitter Melon Extract, Banaba Extract, etc. in Vicare brand DiabeCare; and Goldenseal, Echinacea, etc. in Lakeway Essentials brand Immune Boost.

6. Your product, Lakeway Essentials brand Immune Boost, is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

7. Your products, Vicare brand DiabeCare, Lakeway Essentials brand Immune Boost, and GC Naturals brand CSDP Gold, are misbranded within the meaning of section 403(q)(5)(F) of the FD&C Act [21 U.S.C. § 343 (q)(5)(F)] in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. For example:

a. The Vicare brand DiabeCare product label fails to declare the dietary ingredients contained in the proprietary blend in descending order of predominance by weight, as required by 21 CFR 101.36(c)(2).
b. The Vicare brand DiabeCare product label declares chromium polynicotinate. The quantitative amounts by weight shall represent the weight of the dietary ingredient rather than the weight of the source of the dietary ingredient (e.g., the weight of chromium rather than that of chromium polynicotinate) [21 CFR 101.36(b)(2)(ii)]. 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", e.g., "Chromium (as chromium polynicotinate)" [21 CFR 101.36(d)].
c. The Vicare brand DiabeCare product label declares Biotin (B7) whereas B7 is not the nomenclature or synonym specified for biotin in 21 CFR 101.9 or 101.36(b)(2)(i)(B). Furthermore, the label fails to declare the % Daily Value for biotin as required by 21 CFR 101.36(b)(2)(iii).
d. The Vicare brand DiabeCare product label fails to declare the (b)(2)-dietary ingredients and “other dietary ingredients” in the order and format prescribed in 21 CFR 101.36. The (b)(2)-dietary ingredients must be listed in the order prescribed in 21 CFR 101.36(b)(2)(i) followed by a heavy bar and then “other dietary ingredients”.
e. The GC Naturals brand CSDP Gold product label fails to place the subheading "Serving Size" under the heading "Supplement Facts" and fails to place the subheading "Servings Per Container" shall be placed under the subheading "Serving Size" in accordance with 21 CFR 101.36(b)(1)(i) and 101.36(b)(1)(ii). Furthermore, the label fails to place the dietary ingredient name on the same line as its quantitative amount per serving and % Daily Value.
f. The Lakeway Essentials brand Immune Boost product label fails to declare the source of pantothenic acid. 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." When a source ingredient is not identified within the nutrition label, it shall be listed in an ingredient statement in accordance with 101.4(g) [21 CFR 101.36(d)].
g. The Lakeway Essentials brand Immune Boost product label fails to place light and heavy bars is not in accordance with 21 CFR 101.36(e).

8. Your product, Lakeway Essentials brand Immune Boost, is misbranded within the meaning of sections 403(q)(5)(F) and 403(s)(2)(A) of the Act [21 U.S.C. §§ 343(q)(5)(F) and 343(s)(2)(A)] in that the label fails to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and the quantity of each such ingredient. For example, the product label contains ingredient information to suggest that the product contains goldenseal, echinacea, and garlic. The Supplement Facts label fails to declare these dietary ingredients and the quantitative amount by weight per serving of each as required by 21 CFR 101.36(b)(3).

9. Your product, Vicare brand DiabeCare, is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but it does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

10. Your product, Lakeway Essentials brand Immune Boost, is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] because the label declares the source of vitamin A as “fish liver oil” but fails to identify the species of fish allergen source.

Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines a major food allergen as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:

The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)]; or

The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].

Specifically, the Lakeway Essentials brand Immune Boost product label does not declare the specific type of fish present in the product. A declaration of the “species” of fish for purposes of complying with Section 403(w)(2) of the Act [21 U.S.C. § 343(w)(2)] should be made using the acceptable market name provided in FDA's The Seafood List. We note, however, that if a “Contains” statement is used to declare the source of the fish we would not object to just the type of fish being used, e.g., “Contains trout.”

This letter is not an intended to be an all-inclusive list of violations in connection with your products. It is your responsibility to ensure that your establishment and your products comply with the FD&C Act and its implementing regulations. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

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

Your written response should be sent to:

Sergio Chavez, Director, Compliance Branch

Food and Drug Administration
Office of Human and Animal Foods Division West 5
19701 Fairchild
Irvine, CA 92612

Refer to Unique Identification Number CMS# 597677 when replying.

If you have any questions regarding this letter, please contact Sara J. Dent Acosta, Compliance Officer, at sara.dent@fda.hhs.gov or (619) 941-3767.

Sincerely,
/S/

Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations –West Division 5

______________________________________

1 Section 505G was added to the FD&C Act by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), enacted on March 27, 2020.
2 Under section 505G(b)(8), final monographs were deemed to be final administrative orders upon enactment of the CARES Act.
3 BIO-MINT Nasal Spray also does not satisfy requirements for marketing without an approved application under section 505G(a)(3), nor is its marketing permitted by an order issued under section 505G(b)(1).

 
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