Editor's Note
FDA issued this warning letter to NutraCap Labs LLC alleging multiple violations of cGMP requirements and adulterated products allegedly containing unsafe food additive 2-amino-5-methylheptane (DMHA). FDA reminds the company that a substance added to food that is not generally recognized as safe (GRAS) by qualified experts and does not qualify for any of the other exemptions from the food additive definition, it is a food additive. Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated.
The United States Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 6080 McDonough Drive, Suite A, Norcross, GA from November 5 - December 11, 2019. During the inspection, our investigators also collected and reviewed labeling for your products. Based on the inspectional findings and subsequent review of your product labels, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s homepage at  www.fda.gov.

At the close of the inspection, you were issued an FDA Form 483, Inspectional Observations. We acknowledge receipt of your written response, dated January 2, 2020. We have reviewed your response and discuss your significant violations and your corrective actions below.

Adulterated Dietary Supplements

Your dietary supplement products are adulterated 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 the CGMP regulations for dietary supplements found in 21 CFR Part 111. During the inspection, we observed the following significant violations of the CGMP regulations for dietary supplements:

1. You failed to approve or reject all processes, specifications, controls, test and examinations that may affect the identity, purity, strength, or composition of a dietary supplement, as required by 21 CFR 111.105(a). Specifically, in the manufacture of the dietary supplement  (b)(4) , manufactured November 20, 2019, you increased from  (b)(4)  mg per serving the contents of the ingredient  (b)(4) , but the change in specifications was not reviewed or approved by quality control. Additionally, in manufacture of your  (b)(4) , manufactured November 6, 2019, you changed suppliers for your  (b)(4)  ingredient, which resulted in a change in the ingredient from  (b)(4)  per serving to  (b)(4)  per serving in the finished product, but the change in specifications was not reviewed or approved by quality control.

Your quality control personnel also failed to perform operations that ensure your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105. During the inspection, a review of the finished product label and BPR for  (b)(4) , lot number  (b)(4)  found that the ingredients listed on the product label are not consistent with the Batch Production Record (BPR). The BPR indicates the lot was manufactured with the ingredients  (b)(4) . However, these ingredients are not declared on the product label you use for this product.1

In your written response, dated January 2, 2020, you provided a new Standard Operating Procedure, “BPR Circulation,” and a training record which addressed the requirements for quality control review and approval of BPRs for stages in the manufacturing process. However, you did not provide supporting documentation, such as an executed BPR, to demonstrate the implementation of the revised procedures. You also provided a revised Standard Operating Procedure PKG‐40‐002, “How to Use and Document a Deviation Record.” Your SOP states, “A second qualified person will check all  (b)(4)  and proposed instructions and sign and date as the approver in the appropriate space at the top of the record”; however, it is unclear whether the SOP includes a step for quality control review and signoff of the deviation form at this critical  (b)(4)  of production.

2. You failed to determine whether component specifications other than identity established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2). Under 21 CFR 111.75(a)(2), you must either conduct appropriate tests or examinations or rely on a certificate of analysis (COA) from the supplier of the component that you receive, provided that the COA meets specific requirements. You receive dietary ingredients, including botanical ingredients from domestic and international suppliers, and you do not typically perform any heavy metal testing, choosing instead to rely on the results of your suppliers’ COAs. However, you may only rely on a COA from a supplier of the component if the following conditions are met: (A) you first qualify the supplier by establishing the reliability of the supplier's COA through confirmation of the results of the supplier's tests or examinations; (B) the COA includes a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations; (C) you maintain documentation of how you qualified the supplier; (D) you periodically reconfirm the supplier's COA; and (E) your quality control personnel review and approve the documentation setting forth the basis for qualification (and re‐qualification) of any supplier. You have not qualified any suppliers by confirming the reliability of the COA.

In your written response, dated January 2, 2020, you stated your plans to draft and release a new Standard Operating Procedure for implementing a vendor verification program by January 20, 2020. You further stated that by February 29, 2020, you were going to engage a  (b)(4) . We are unable to evaluate the adequacy of this corrective action, as you have not provided a copy of the new SOP or other supporting documentation. Additionally, your plan to address this issue with regard to botanicals already received is unclear.

3. Your firm’s MMR did not include a representative label, or cross reference to the physical location of the actual or representative label, as required by 21 CFR 111.210(g). Specifically, the MMRs for your  (b)(4)  did not include a representative label or reference to the physical location of the label.

In your written response, dated January 2, 2020, you provided a new Standard Operating Procedure ADM‐00‐015, “Master Manufacturing Record Preparation,” which addresses the step for inclusion of a representative label in the MMR. You stated that NutraCap will complete personnel training and the update of all MMRs by March 31, 2020; however, you have not provided such documentation for our review. Therefore, we are unable to evaluate the sufficiency of your corrective action.

4. You failed to suitably dispose of labels and packaging for dietary supplements that are obsolete or incorrect to ensure that they are not used in any future packaging and labeling operations, as required by 21 CFR 111.415(h). Specifically, during the inspection, on November 21, 2019, and December 4, 2019, our investigators observed different boxes of dietary supplement labels that were no longer in use in the labeling room, near the production warehouse, which could potentially cause mix‐up and use in manufacturing.

In your response, dated January 2, 2020, you reported that NutraCap will draft a new Standard Operating Procedure by January 20, 2020, for disposition of labeling rolls containing  (b)(4)  product labels and requirements for labeling rolls containing  (b)(4)  product labels. However, you have not provided a copy of your SOP or training records; therefore, we are unable to evaluate the adequacy of these corrective actions.

Adulterated Dietary Supplements: Unsafe Food Additive

Your  (b)(4)  are adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] because they contain 2-amino-5-methylheptane (DMHA), an unsafe food additive under section 409(a) of the Act [21 U.S.C. § 348(a)]. If a substance added to food is not generally recognized as safe (GRAS) by qualified experts for its intended use in food and does not qualify for any of the other exemptions from the food additive definition, it is a food additive.2 Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(C)(i)].

The definition of “food additive” in section 201(s) of the Act [21 U.S.C § 321(s)] does not include dietary ingredients used in dietary supplements as defined in section 201(ff)(1) of the Act [21 U.S.C § 321(ff)(1)] or substances that are GRAS under the conditions of intended use. DMHA does not qualify as a dietary ingredient under section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)] because it is not a vitamin, mineral, amino acid, herb or other botanical, dietary substance for use by man to supplement the diet by increasing the total dietary intake, or concentrate, metabolite, constituent, extract, or combination of any of the preceding dietary ingredient types. Neither is DMHA GRAS under its conditions of use in your dietary supplement product. Because DMHA does not qualify as a dietary ingredient and is not GRAS or otherwise exempt from the food additive definition, your  (b)(4)  products are adulterated under section 402(a)(2)(C)(i) of the Act because they contain an unsafe food additive. The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under section 301(a) of the Act [21 U.S.C. § 331(a)].3

This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and/or injunction. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

Section 743 of the Act (21 USC 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection-related costs. A reinspection 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. 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 USC 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.

Please notify this office in writing within fifteen working days of the receipt of this letter as to the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations. In your response, you should include documentation, including revised procedures, results of tests you have conducted, and 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 the corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.

2020 Annual Fund Sponsors: