The Food and Drug Administration (FDA) conducted an inspection of your facility located at 1450 Firestone Parkway Suite H, Akron, OH 44301, from December 28, 2017, to January 26, 2018. During the inspection, our investigator identified a number of violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplement regulations, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your dietary supplements 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 regulations for dietary supplements.
We also reviewed the labeling of your “AM/PM FAT BURNING & APPETITE SUPPRESSING WEIGHT CONTROL PATCHES,” including your websites, www.24hourthermogenics.com, www.dietcenter.com, and www.pwlc.com, where you market and/or offer for sale the “AM/PM Weight Control Patches.” Based on our review, we have determined that your “AM/PM Weight Control Patches” is an unapproved new drug in violation of sections 505(a) and 301(d) of the Act [21 U.S.C. §§ 331(d) and 355(a)].
In addition, we have reviewed the labeling for your Diet Center and the Advanced 24 Hour Thermogenics brand products, including product labels and your websites at www.dietcenter.com and www.24thermogenics.com. Based on our review, we have concluded that your products are misbranded under section 403 of the Act [21 U.S.C. § 343], and regulations implementing the dietary supplement labeling requirements of the Act, which are found in 21 CFR 101. You can find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
Unapproved New Drug
Your product “AM/PM FAT BURNING & APPETITE SUPPRESSING WEIGHT CONTROL PATCHES” is a drug under section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)], because it is an article (other than food) intended to affect the structure or any function of the body. Claims on your product label, promotional labeling, and websites, www.24hourthermogenics.com, www.dietcenter.com, and www.pwlc.com, that document the intended use of your product include, but are not limited to, the following:
“Fat Burning & Appetite Suppressing”
“Burn the fat . . . Kill the hunger . . . Lose the weight . . .”
“The AM Patch helps promote weight loss with ingredients that target fat burning, increased energy and enhanced metabolism . . .”
“The PM Patch helps promote weight loss with ingredients that focus on evening appetite suppression . . .”
Moreover, the “AM/PM FAT BURNING & APPETITE SUPPRESSING WEIGHT CONTROL PATCHES” is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)], because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it.
Dietary Supplement CGMP Violations
The December 28, 2017, to January 26, 2018, inspection of your facility revealed the following significant violation of the CGMP requirements for dietary supplements: 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, you have no written procedures for the responsibilities of the quality control operations.
We acknowledge receipt of your written response to the FDA 483 (Inspectional Observations), which we received on February 23, 2018. Your response states, “All our current bottles that are re-bottled for use in our online kits will now come prepackaged with expiration dates and specific lot numbers contained on the bottle labels,” and “All our supplements will now be prepackaged by our manufacturer.” This response does not address the requirements to establish and follow written procedures for the responsibilities of your quality control operations for approving for release, or rejecting, any packaged and labeled dietary supplements received at your firm for distribution. While we acknowledge that you now plan to contract out the manufacturing, packaging, and labeling of your dietary supplements, to the extent that another firm manufactures, packages, and/or labels your dietary supplements on your behalf 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 your firm can make decisions related to whether the packaged and labeled 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)]. Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot 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 or 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 out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). Your firm’s quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of your dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105. Further, your firm must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 21 CFR 111.140(b)(2)).
Once you have established your quality control written procedures, you must implement quality control operations in your holding operations, as required by 21 CFR 111.65.
Misbranded Dietary Supplements
In addition, we performed a review of the labeling for your dietary supplement products and found that they are misbranded under section 403 of the Act (21 U.S.C. § 343) in that the labeling for these products does not comply with the labeling requirements for dietary supplements, as follows:
- Your Diet Center Cal-Mag 90 tablets and 28 tablets, Diet Center Vitamin & Mineral, and Diet Center Anti-Oxidant products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labeling for each product fails to include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
- Your Diet Center Cal-Mag 28 tablets, Diet Center Vitamin & Mineral, and Diet Center Anti- Oxidant” products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C.§ 343(q)(5)(F)] because the presentation of nutrition information is not in accordance with 21 CFR 101.36. For example:
- Your Diet Center Cal-Mag 28 Tablets product label does not indicate the number of servings, as required by 21 CFR 101.36(b) .
- Your Diet Center Cal-Mag 28 tablets, Vitamin & Mineral, and Anti-Oxidant” product labels do not use the required term Daily Value (DV), as required by 21 CFR 101.36(b)(2)(iii)(A); the labels incorrectly list the term “U.S. RDA”.
- Your Diet Center Cal-Mag 28 tablets, Vitamin & Mineral, and Anti-Oxidant” product labels fail to indicate “Supplement Facts” and present the nutrition information in the appropriate format, as required by 21 CFR 101.36(e).
- Your Diet Center Cal-Mag 28 tablets product label fails to indicate the source of the calcium, as required by 21 CFR 101.36(d).
- Your 24 Hour Thermogenics Powerful Liquid Enhancing Concentrate product label fails to list (b)(3)-dietary ingredients within the Supplement Facts label, as required by 21 CFR 101.36(b)(3). Furthermore, we note that some of the botanical (b)(3)-dietary ingredients do not include the specific plant part. In particular, if the entire or whole plant is used, that information should be included in the listing of the dietary ingredient.
Your Diet Center Cal-Mag 28 Tablets product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the product label fails to include a serving size in accordance with 21 CFR 101.36(b). The terms "serving" or "serving size" for a dietary supplement are defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2, as the maximum amount recommended on the label for consumption per eating occasion.
3. Your 24 Hour Thermogenics Powerful Liquid Enhancing Concentrate and 24 Hour Thermogencis EFA’s Essential Fatty Acid Supplement products, and Diet Center Cal-Mag 90 Tablets and 28 Tablets, Diet Center Vitamin & Mineral, and Diet Center Anti-oxidant product label(s) are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that each product 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 supplements. Specifically, each product label does not include a complete domestic address or domestic phone number.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. It is your responsibility to ensure that your products comply with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective actions may subject your firm and products to further actions, such as injunction or seizure.
Additionally, we have the following comments:
- Your 24 Hour Thermogenics EFA’s Essential Fatty Acid Supplement and Powerful Liquid Enhancing Concentrate, Diet Center Cal-Mag, Diet Center Vitamin & Mineral and Diet Center Antioxidant products are misbranded under section 403(e)(1) [21 U.S.C. § 343(e)(1)] of the Act in that the labels fail to declare the place of business, including the ZIP code, in accordance with 21 CFR 101.5. You should verify all your product labels to make sure they meets this requirement.
- Your 24 Hour Thermogenics Powerful Liquid Enhancing Concentrate and 24 Hour Thermogenics EFA’s Essential Fatty Acid Supplement products, and Diet Center Antioxidant product label(s) are misbranded under section 403(r)(6) in that the labels fail to make a declarative statement for the lack of evaluation of the product by FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease in accordance with 21 CFR 101.93(c)(1). We note the terms “thermogenic” and “anti-oxidant” are structure function claims.
- Your 24 Hour Thermogenics Powerful Liquid Enhancing Concentrate product label declares chromium polynicotinate as a dietary ingredient. Chromium is a (b)(2)-dietary ingredient (see 21 CFR 101.36(b)(2)). If the serving size contains 2% or more of the RDI for chromium, the chromium should be declared in the supplement facts label section intended for (b)(2)-dietary ingredients. The source of the chromium may be declared either following the declaration of chromium and/or in the ingredients list” in accordance with 21 CFR 101.36(d) and 21 CFR 101.4(g).
- Your 24 Hour Thermogenics Powerful Liquid Enhancing Concentrate contains the statement “Percent Daily Value based on a 2,000 Calorie Diet.” This statement is required when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein in accordance with 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D).
- Your 24 Hour Thermogenics Powerful Liquid Enhancing Concentrate contains the term “Vitamin B3” within the supplement facts label. The correct name should be only “niacin” in accordance with 21 CFR 101.9(c)(8)(iv).
- You told the FDA investigator that you intended to market “AM/PM Weight Control Patches” as a dietary supplement. However, it does not meet the definition of a dietary supplement under section 201(ff)(2)(A)(i) of the Act [21 U.S.C. § 321(ff)(2)(A)(i)], which defines a dietary supplement, among other things, as a product intended for ingestion. Topical patch products and other products that are not intended for ingestion are not dietary supplements.
If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. You should 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 noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions, as well as copies of related documents. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
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 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, FDA may assess fees to cover any reinspection-related costs.