Inspections, Compliance, Enforcement, and Criminal Investigations

ATS Labs, LLC 2/3/16

  

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

Public Health Service
Food and Drug Administration
 Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204-3128 

February 3, 2016

Ref: 2016-DAL-WL-11
WARNING LETTER
UPS OVERNIGHT MAIL
 
Aiyad Abou-Assaad, Owner
ATS Labs, LLC
2123 Cypress Creek Pkwy #888
Houston, Texas 77090
 
Dear Mr. Abou-Assaad:
 
The U.S. Food and Drug Administration (FDA or we) inspected your facility, located at 4696 Louetta Road, Spring, Texas, from January 21, 2015, through February 2, 2015. During the inspection, our investigator identified significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, which are set out under Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products (Support, Liver Food, Test PSI, Lipo Blast, CFI, Dilate, Winalean, Pro Flex, Lady Lean, and Weapon-X PreWorkout Extreme) 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. Our investigators' observations were noted on Form FDA-483, lnspectional Observations, which was issued to you on February 2, 2015.
 
Additionally, based on our review of the product labeling of your dietary supplements collected during the inspection and your website we have determined that your CFI, Weapon-X Pre-Workout Extreme, and Lady Lean are also adulterated under Sections 402(f) and 413(a) of the Act [21 U.S.C. § 342(f) and 350b(a)], and your Liver Food, CFI, Pro Flex, Lady Lean, Lipo Blast, HGH, and Test PSI are misbranded under Section 403 of the Act [21 U.S.C. § 343].
 
You can find the Act and FDA regulations through links in FDA's home page at http://www. fda.gov.
 
Dietary Supplements CGMP Violations
 
As a distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your firm's name, your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [see 72 Fed. Reg. 34752, 34790 (June 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplements into interstate commerce in their final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.
 
Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has "a responsible share in the furtherance of the transaction which the statute outlaws"); United States v. Park, 421 U.S. 658, 672 (1975) {holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that "agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act" can be held accountable for violations of the Act).  In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery for introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. 342(g) and 331(a)). Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.
 
During the inspection, our investigator observed the following significant violations:
 
1.    You failed to establish specifications to provide sufficient assurance that the product you received for packaging or labeling as a dietary supplement is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f).
 
Specifically, you perform the finished product labeling for Support, Liver Food, Test PSI, LipoBlast, CFI, Winalean, ProFiex, and Lady Lean products. You stated during the inspection that you do not have specifications for these products.
 
Your response dated February 24, 2015, states that you plan to create product specification pages for your products. However, although your response indicates that you attached a "Label-Product Specification Page," this document was not attached. We are therefore unable to evaluate the adequacy of your response.
 
2.    You failed to establish and follow written procedures for the responsibilities of your quality control operations, as required by 21 CFR 111 .1 03. Quality control personnel must ensure that your operations ensure the quality of the dietary supplement, as described in 21 CFR 111.105. During the inspection you were unable to provide any written procedures for quality control operations. You did not have an employee assigned to oversee quality control operations.
 
We acknowledge that your response, dated February 24, 2015, stated that you had a goal of establishing written procedures for quality control during the next (b)(4) business days. However, you did not submit your written procedures and we are therefore unable to assess their adequacy. We will evaluate your corrective action during our next inspection.
 
3.    You failed to establish a batch production record relating to your labeling operations in accordance with the requirements in 21 CFR 111.255 and 111.260. Specifically, you did not have batch production records for dietary supplements you labeled and distributed, including your Support, Liver Food, Test PSI, LipoBlast, CFI, Winalean, ProFiex, and Lady Lean, products.
 
We acknowledge in your response dated February 24, 2015, you indicated that you will establish batch production records for the dietary supplement products you label at your firm. However, we are unable to evaluate the adequacy of your response because you referred to attachments/supporting documents in your response, but you failed to include them in your actual response.
 
4.    You failed to assign a batch, lot, or control number to each lot of packaged and labeled dietary supplement from a finished batch of dietary supplement, as required by 21 CFR 111.415(f)(1). Specifically, you have not assigned a batch, lot, or control number for each lot of the dietary supplements your firm labels and distributes. These dietary supplements include Support, Liver Food, Test PSI, Lipo Blast, CFI, Winalean, ProFiex, and Lady Lean.
 
We acknowledge that your response dated February 24, 2015, stated that you have a goal, within (b)(4) business days, of asking (b)(4) to add a batch number to each batch of product you receive. We will evaluate the adequacy of your response at our next inspection.
 
5.    You failed to establish specifications for the labeling of the finished packaged and labeled dietary supplement products Support, Liver Food, Test PSI, LipoBlast, CFI, Winalean, ProF/ex, and Lady Lean, including specifications to ensure that you applied the specified label, as required by 21 CFR 111.70(g). Once you have established labeling specifications, you must ensure that they are met, for example by examining a representative sample of each batch of the packaged and labeled dietary supplement, as set forth in 21 CFR 111.415(g), to determine whether the dietary supplement meets the specifications established in accordance with 21 CFR 111.70(g).
 
We acknowledge that your response, dated February 24, 2015, stated that you had a goal of establishing label specifications for each of your products within (b)(4) business days. You did not submit examples of such label specifications, and we are therefore unable to assess their adequacy. We will evaluate your corrective action during our next inspection.
 
6.    Your firm did not collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). For each lot of packaged and labeled dietary supplements that you distribute, your firm must collect reserve samples and hold the samples in accordance with 21 CFR 111.83(b). For examples:
 
•    Using the same container-closure system in which the packaged and labeled dietary supplements were distributed [21 CFR 11 1.83(b)(1)].
 
•    Reserve samples must be identified with the appropriate batch, lot, or control number [21 CFR 111.83(b)(2)].
 
•    Be retained for at least (1) year past the shelf life date (if shelf life dating is used), or for two (2) years from the date of distribution of the last batch of dietary supplements associated with the reserve sample [21 CFR 111.83(b)(3)].
 
•    Consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specification [21 CFR 111.83(b)(4)].
 
We acknowledge that your response, dated February 24, 2015, stated that you are creating a space to hold reserve samples and that you have begun to collect and hold (b)(4) reserve samples of each new batch of product you receive for products that "(b)(4)." Your response did not indicate whether you are holding these samples in compliance with all of the requirements under 21 CFR 111.83(b). Furthermore, your response is inadequate because you are required to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, not just the supplements that you distribute under your firm's name.
 
7.    You failed to establish and follow written product complaint handling procedures, as required by 21 CFR 111.553. Under 21 CFR 111.533, you must establish and follow written procedures to fulfill the requirements of 21 CFR Part 111, Subpart 0, which relates to product complaints. Specifically, your written procedures must specify that a qualified person review all product complaints to determine if the complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirement of 21 CFR Part 111, in which case the qualified person must investigate the complaint (see 21 CFR 111.560(a)); and quality control personnel must review and approve decisions about whether to investigate a product complaint and review and approve the findings and follow-up action of any investigation performed (see 21 CFR 111.560(b)). Furthermore, your written procedures must specify that the reviews and investigation described above, and the findings and follow-up action of any investigation performed, must extend to all relevant batches and records (see 21 CFR 111.560(c)). Finally, your procedures must include making and keeping the records described in 21 CFR 111 .570.
 
We have reviewed your response dated February 24, 2015, and determined that your response is inadequate. Your response states that you will create written procedures that will discuss how to approach a complaint and the steps to fix it, including whether to have a product tested. This response is inadequate because it is not clear that your written procedures will fulfill the requirements of Subpart 0, which are described above.
 
8.    Your firm failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111 .453. Specifically, you stated that you do not have written procedures for holding and distributing operations.  Your written procedures for holding and distributing operations must include procedures for complying with all relevant parts of 21 CFR Part 111, Subpart M, including requirements about: holding dietary supplements and labels (see 21 CFR 111.455), holding reserve samples of dietary supplements (see 21 CFR 111.465), and distributing dietary supplements (see 21 CFR 111.470). Further, once you establish written procedures for your holding and distributing operations, you must make and keep records of such written procedures, as required by 21 CFR 111.475(b)(1).
 
We have reviewed your response dated February 24, 2015, and determined that it is inadequate. Your response indicated that you are in the process of developing SOPs to ensure products are stored under appropriate conditions. Specifically, you state that your procedures will include storing product at room temperature, out of sunlight, in a clean environment, and in an environment that ensures that the product's identity, purity, strength, and composition are not affected, and that its packaging is not disturbed. This response is inadequate because it is not clear that your written procedures will fulfill the requirements of Subpart M.
 
Adulterated Dietary Supplements
 
Your products, CFI, Weapon-X Pre-Workout Extreme, and Lady Lean, are labeled and/or offered for sale as dietary supplements. The Supplement Facts panels of these products declare 4-amino-2-methylpentane citrate as a dietary ingredient. This ingredient is also called, among other names, 1 ,3-Dimethylbutylamine, DMBA, 2-amino 4-methylpentane, AMP citrate, and 4-methyl-2-pentanamine, and will be referred to in the rest of this letter as DMBA.
 
The term "dietary supplement" is defined in section 201 (ff) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)]. Given that you have declared DMBA as a dietary ingredient in the labeling of your products, we assume you have a basis to conclude that DMBA is a "dietary ingredient" under 21 U.S.C. § 321 (ff)(1 ). Assuming that DMBA is a "dietary ingredient," it would also be a "new dietary ingredient" for which a notification is required under section 413(a)(2) of the Act [21 U.S.C. § 350b(a)(2)] and 21 CFR 190.6.
 
Under section 413 of the Act, [21 U.S.C. § 350b], a dietary supplement that contains a new dietary ingredient (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) shall be deemed adulterated under section 402(f) of the Act [21 U.S.C. § 342(f)] unless it meets one of two requirements:
 
1.    The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or
 
2.    There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
 
To the best of FDA's knowledge, there is no information demonstrating that DMBA was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered. In the absence of such information, DMBA is subject to the notification requirement in section 413(a)(2) of the Act [21 U.S.C. § 350b(a)(2)] and 21 CFR 190.6. Because the required notification has not been submitted, your products are adulterated under sections 402(f)(1}(8) and 413(a) of the Act [21 U.S.C. § 342(f)(1)(8) and 350b(a)].
 
Even if the required notification had been submitted, we know of no evidence that would establish that your product is not adulterated. In the absence of a history of use or other evidence of safety establishing that DMBA, when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe, CFI, Weapon-X Pre-Workout Extreme, and Lady Lean are adulterated under sections 402(f)(1 )(B) and 413(a) of the Act [21 U.S.C. §§ 342(f)(1 )(B) and 350b(a)] because they contain a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such a product into interstate commerce is prohibited under sections 301(a) and (v) of the Act [21 U.S.C. § 331(a) and (v)]. To the best of FDA's knowledge, there is no history of use or other evidence of safety establishing that DMBA will reasonably be expected to be safe when used as a dietary ingredient.
 
It has come to our attention that DMBA used in products in the dietary supplement marketplace may be produced synthetically. Section 201 (ff)(1) of the Act [21 U.S.C. § 321 (ff)(1)] defines "dietary ingredient" as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. Synthetically produced DMBA is not a vitamin, mineral, amino acid, herb or other botanical. To the best of FDA's knowledge, synthetically produced DMBA is not commonly used as human food or drink. Further, synthetically produced DMBA is not a concentrate, metabolite, constituent, extract or combination of the preceding categories. Therefore, synthetically produced DMBA is not a dietary ingredient as defined in section 201(ff)(1) of the Act.
 
Misbranded Dietary Supplements
 
1.    Your Liver Food, CFI, Pro Flex, HGH and Lady Lean products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. 343{y)] in that the labels fail to include 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.
 
2.    Your Test PSI product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(sX2)(C)] in that the label fails to identify the part of the plant (e.g. roots, leaves) from which each botanical dietary ingredient (Fadogia Agrestis and Mucuna Pruriens) in the product is derived, as required by 21 CFR 101.4(h)(1).
 
3.    Your Test PSI, Lipo Blast, and Pro Flex products 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 sizes declared on the product labels are 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.
 
•    The directions for use for the Test PSI product suggest to "consume 2 to 3 capsules twice daily," but the serving size lists "4 capsules." The serving size listed should be three capsules.
 
•    The directions for use for the Lipo Blast product suggest to "consume 1 capsule 2 separate times a day," but the serving size lists "2 capsules." The serving size listed should be one capsule.
 
•    The directions for use for the Pro Flex product suggest to "consume 2 capsules 1 or 2 times daily," but the serving size for is "4 capsules." The serving size listed should be two capsules.
 
4.    Your Test PSI product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.4(h) and 101.36. Specifically, your Test PSI product label lists the ingredient Mucuna Pruriens. The Standardized Common Name for this ingredient is velvet bean according to the Herbs of Commerce.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. 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.
 
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/or injunction. Failure to immediately cease distribution of products you market that contain DMBA could result in such enforcement action by FDA without further notice. We also remind you that the new dietary ingredient notification requirement applies to all dietary supplements that contain new dietary ingredients that have not been present in the food supply as articles used for food in a form in which the food has not been chemically altered. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
 
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.
 
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 noncompliance 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Your written response should be sent to Thao Ta, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX, 75204. If you have questions regarding any issues in this letter, please contact Thao Ta at (214) 253-5217.
 
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 
cc:
Stephen Schnitzer, Operations Director
ATS Labs, LLC
4696 Louetta Road
Spring, Texas 77379

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