- Delivery Method:
- UPS Overnight
- Dietary Supplements
Recipient NameSuk H. Cho
Recipient TitleChief Executive Officer
- Cosmax NBT USA
3350 Marquis Dr.
Garland, TX 75042
- Issuing Office:
- Division of Human and Animal Food Operations West III
May 03, 2023
Dear Suk H. Cho:
This is to advise you that the U.S. Food and Drug Administration conducted an inspection of your facility, located at 3350 Marquis Dr., Garland, TX from April 6, 2021, through May 4, 2021. Based on the inspectional findings and review of your product labels 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.
We received your written response letters dated May 25, 2021, August 23, 2021, November 22, 2021, February 18, 2022, and July 28, 2022, written in response to the Form FDA 483 Inspectional Observations, issued to you at the close of the inspection. We have reviewed those responses and our comments are listed following each of the significant violations.
Adulterated Dietary Supplements
The inspection of your facility revealed serious violations of 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, Part 111 (21 CFR 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of 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 regulations for dietary supplements.
1. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contaminants that may adulterate, or that 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(e). Specifically, you have no product specifications for the (b)(4) Multimineral product that you manufacture.
We have reviewed your written responses.
Your July 28, 2022 response states that Cosmax has completed the full review and updates to finished product specifications and has corrected all finished product specifications for products being manufactured and distributed to customers. Your response includes revised finished product specifications for your products, including: (b)(4) Multimineral.
Based on our review of the revised finished product specifications, your response is inadequate because the finished product specifications do not meet the requirements of 21 CFR 111.70(e). Specifically,
- For the (b)(4) Multimineral, the specification for Taste/Aroma states “Meets Reference.” “Meets Reference” does not provide a description of the taste or smell that is characteristic of the products.
2. You failed to establish component specifications, as required by 21 CFR 111.70(b), for each component that you use in the manufacture of a dietary supplement. Specifically, you did not establish component specifications that are necessary to ensure that specifications for the purity, strength and composition of the dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). For example, you have not established component specifications for the purity, strength, and composition of your (b)(4). We also note that you must establish an identity specification for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). The identification specification for each ingredient states “Validated Ref STD.” The specification is not appropriate because it does not state the specific acceptance criteria for comparison that will be used to confirm the identity of the ingredient for the test performed.
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 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). You must also ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records of the specifications established, as required by 21 CFR 111.95(b)(1).
We have reviewed your responses, and we are unable to evaluate the adequacy of your corrective actions. The documents that you purport to be component specifications in your May 25, 2021 and November 22, 2021 responses do not demonstrate that you have established specifications for purity, strength, and composition of the components that are necessary to ensure that specifications for the purity, strength and composition of the dietary supplements manufactured using the components are met.
3. You failed to verify that your finished batch of (b)(4) Lot (b)(4) meets products specifications for limits for those types of contamination that may adulterate or that may lead to adulteration of the finished batch of dietary supplement specifically, pesticides as required by 21 CFR 111.75(c). Specifically, the pesticide testing report dated 06/09/2020 for the finished product (b)(4) from your third-party party lab, had the product lot # (b)(4) crossed out and changed to lot # (b)(4) (the hand-written change was initialed and dated as “AS 06/09/2020” only on page 1 of 5 of the pesticide test record). Upon review of the Batch Manufacturing Records for (b)(4) Lot # (b)(4), it was observed that this product lot was manufactured on 09/22/2020, 3 months after the pesticide results were generated from the third-party lab.
We have reviewed your responses in which you state the observation resulted from a failure to comply with the firm’s Good Documentation Practices procedure SOP AGP-017 “Good Documentation Practices”; for which you re-trained your employees on SOP AGP-017. We are unable to evaluate the adequacy of your response because that you did not provide documentation to support that you have verified that (b)(4) Lot # (b)(4) meets product specifications for pesticides.
4. Before using a component, you failed to 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). Specifically, your firm received the dietary ingredient (b)(4), lot # (b)(4), on June 5, 2019. This was used to manufacture the finished dietary supplement (b)(4) (lot # (b)(4)), which was distributed to your customer on March 11 and 30, 2021. The raw material was not tested for identity until April 5, 2021.
Your firm’s May 25, 2021 response indicated that raw materials received prior to June 2020 could be approved in your system without identification testing being performed. We are unable to evaluate the adequacy of your response because you did not provide documentation to support that you have conducted identity testing for those dietary ingredients received prior to 2020 that remain in your inventory.
Misbranded Dietary Supplements
In addition, the products, (b)(4), and (b)(4) products are misbranded dietary supplements within the meaning of section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101 as follows:
1. The (b)(4), and (b)(4) products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. For example:
- The (b)(4) product Supplement Facts label fails to declare the nutrition information for which the product is intended. The percent of Daily Value shall be based on RDI or DRV values for adults and children 4 or more years of age, unless the product is represented or purported to be specifically for infants through 12 months of age, children 1 through 3 years of age, pregnant women, or lactating women, in which case the column heading shall clearly state the intended group. If the product is for persons within more than one group, the percent of Daily Value for each group shall be presented in separate columns as shown in paragraph (e)(11)(ii) of this section.
- The (b)(4) product label declares dietary ingredients with amounts of 0 or percent Daily Values of 0 or <2%. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) in accordance with 21 CFR 101.36(b)(2)(i).
- The (b)(4) product label fails to declare milligrams as the unit of measure for copper. [21 CFR 101.36(b)(i) and 21 CFR 101.9(c)(8)(iv)]
- The Quinol Turmeric product bears the following statement: “Percent Daily Values based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D).
- The (b)(4) product declares “Vitamin D3” in the Supplement Facts label which is not in accordance with 21 CFR 101.36(b)(2)(i)(B) and 101.9(c)(8)(iv).
- The (b)(4) nutrition information declares 10 calories per serving; however, the amount does not appear to correlate with the macronutrient that is listed. Likewise, the (b)(4) nutrition information declares 5 calories per serving and there are no macronutrients listed to correlate with the amount.
2. The (b)(4) and (b)(4) 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 names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example,
- The (b)(4) and product labels list the ingredient stevia extract (leaves) but do not specify the steviol glycoside. We note your MMR for each product indicates the ingredient is Stevia leaf 97% (Rebaudioside A 97%). The common or usual name for highly purified steviol glycosides depends on the ingredient composition. If the sweetener is purified to contain 95 percent or more of a single steviol glycoside, the specific name of that single steviol glycoside is the common or usual name. For example, the name “rebaudioside A” should be used for ingredients with 95% or more rebaudioside A; the name “stevioside” should be used for ingredients with 95% or more stevioside. If the sweetener is purified to contain 95 percent or more of a mixture of two or more steviol glycosides, the name “steviol glycosides” would be the common or usual name.
- The (b)(4) product lists the ingredients “(b)(4)”, each of which is not the common or usual name of the ingredient.
We also offer the following comments:
1. During the inspection, your firm’s product “(b)(4) 32 fl oz.” was documented as an acidified food. FDA acknowledges your firm’s response which indicates that you had submitted the Food Canning Establishment registration, which has been verified, and are working with a process authority to evaluate and define a scheduled process. Failure to implement proper acidified food quality control procedures could result in finish foods that present a health hazard. Your firm’s compliance with acidified food regulations will be assessed during the next inspection.
2. For the (b)(4) product, the current regulation pertaining to nutrition information allows the voluntary listing of Calories from Saturated Fat, and not Calories from Total Fat. [21 CF 101.36(b)(2)(i) and 21 CFR 101.9(c)(i)(ii)].
3. The (b)(4) product declares the statement of identity “dietary supplement.” However, we note the label also declares “(b)(4)”. Per Section 201(ff) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 321(ff)], the term “dietary supplement” means a product that is not represented for use as a conventional food or as a sole item of a meal or the diet. As such, your product cannot be labeled as a dietary supplement, and simultaneously represented for use as a conventional food.
4. The (b)(4) product declares the statement “Manufactured in a facility that processes egg, wheat, milk, soy, tree nuts, peanut, fish & shellfish products.” The use of an advisory label such as this is not an acceptable substitute for food allergen control procedures to prevent cross contact. The firm should make every effort to assure that they and their suppliers have adequate GMP's in place to prevent the un-intentional inclusion of allergens in their products and ingredients.
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to Chad J. Whitwell, Compliance Officer, U.S. Food and Drug Administration, 1201 Main St, Suite 7200, Dallas, TX 75202. If you have questions regarding any issues in this letter, please contact Mr. Whitwell at 214-253-5328.
Edmundo Garcia, Jr.
Program Division Director HAF West 3