On April 24 and 25, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 267 E 1400 S, Suite 101, St George, Utah
, where our investigators found a number of violations of the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21 Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your products 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 insanitary conditions that do not meet CGMP regulations for dietary supplements.
In addition, we reviewed your product labels collected during the inspection and your website at the Internet address www.mega-pro.com in May 2017. Based on our review, we have concluded that certain products are in violation of sections 403, 505(a), and 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and 352(f)(1)] and regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101.
You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
To date, we have not received a written response from you.
Unapproved New Drugs
FDA reviewed your website at the internet address www.mega-pro.com in May, 2017, and have determined that you take orders there for your products, including Chromium Picolinate, Creatine, and DHEA.
The therapeutic claims on your website establish that your Chromium Picolinate, Creatine, and DHEA products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Specialty Products Alertness / Energy
* Chromium Picolinate "...play a role in lowering cholesterol, normalizing high blood sugar..."
* DHEA: "...linked DHEA depletion with almost every major degenerative disease..."
Your website also contains evidence of intended use in the form of excerpts from an article promoting the use of creatinine monohydrate supplements for the cure, mitigation, treatment, or prevention of disease. Excerpts from the article,
Creatine Does More Than Rock Your Bod, under the MEGA-PRO NEWS page include:
* Bones over Brawn: "Creatine monohydrate (Cn) supplements...osteoporosis...plus for those suffering from this bone disease...elderly... osteoporosis, osteoarthritis..."
* Neurodegenertive Diseases: "...diseases...Parkinson's disease, Huntington's disease, and Amyotrophic lateral sclerosis - may also find a friend in Cn...Energy depletion, mitochondrial dysfunction...are key factors involved in these types of disorders...Cn can positively affect each of these symptoms...The National Parkinson Foundation...entire Parkinson's disease community hold out hope that Cn will affect disease progression in a positive way..."
Your Chromium Picolinate, DHEA, and Creatine products are not generally recognized as safe and effective for the above-referenced uses and therefore, the products are "new drugs" under section 201(p)(1) of the Act [21 U.S.C. § 321(p)(1)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Additionally, a drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your products Chromium Picolinate and Creatine are intended for the treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use these products safely for their intended purposes. Accordingly, your Chromium Picolinate and Creatine products fail to bear adequate directions for their intended use and, therefore, they are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Adulterated Dietary Supplements
Even if your Chromium Picolinate, Creatine, and DHEA
products did not have therapeutic claims which make them unapproved new drugs, these products, and your Mega Cut Fat Burner,Stim & Trim Fat Inferno, and Inosine would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. §342(g)(1)] because the products have been held under conditions that do not meet the requirements of Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (CGMP) regulation, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
We note that during the inspection, your firm stated that your firm holds and distributes your products and that your contract manufacturer(s) is/are responsible for all product specifications. Your firm, however, also told us that your firm participates in the development of new products and that you provide final approval. Your firm also told our investigator that you are responsible for the label design and label artwork for your products and that your contract manufacturer completes the supplement information section of the label.
The significant CGMP violations documented during the inspection include, but are not limited to, the following:
1. 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, during the inspection it was observed that you do not have any written quality control operations in place to perform quality control functions, such as reviewing documentation from the manufacturers with whom you contract relating to how your dietary supplement products are manufactured and whether they conform to established specifications.
You must also implement quality control operations, as required by 21 CFR 111.65 to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
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, packaging, and/or labeling 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. [72 Fed. Reg. 34752, 34790 (Jun. 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).
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). The quality control personnel must ensure that the 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 (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).
2. You failed to 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). Specifically, during the inspection, your firm stated to our investigator that you do not keep reserve samples. For each lot of packaged and labeled dietary supplements that you distribute, you must collect reserve samples and hold the samples using the same container-closure system in which the packaged and labeled dietary supplements were distributed 21 CFR 111.83(b).
3. You
failed to establish and follow written procedures for holding and distribution operations, as required by 21 CFR 111.453. Specifically, you hold and distribute dietary supplements at your facility; however, you were unable to provide our investigator with a written procedure which describes how your dietary supplements are held and distributed.
4. You
failed to establish and follow written procedures for the requirements related to product complaints as required by 21 CFR 111.553. Specifically, during the inspection your firm stated to our investigator that you handle complaints as they come and that you did not have a written procedure for handling complaints. Your written procedures must fulfill the requirements of 21 CFR 111.560. You must also make and keep a written record of every product complaint that is related to good manufacturing practice, in accordance with 21 CFR 111.570(b)(2).
5. You failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503. Specifically, during the inspection you stated to our investigator that you did not have any written procedures for returned dietary supplements and that returned dietary supplements are discarded. Your written procedure must include procedures for when a dietary supplement must be destroyed or otherwise suitably disposed of, in accordance with 21 CFR 111.515.
Misbranded Dietary Supplements
Your Mega Cut Fat Burner and Stim and Trim Fat Inferno products are misbranded within the meaning of section 403(q)(5)(F) of the Act [U.S.C. § 343(q)(5)(F)]. For example:
1. The Mega Cut Fat Burner product label fails to include the term "Proprietary Blend" or other appropriate descriptive term, as required by 21 CFR 101.36(c). In addition, the dietary ingredients under § 101.36(b)(3), included in the Mega Cut Fat Burner proprietary blend, are not declared in descending order of predominance by weight, and in a column or linear fashion, and are not indented under the "Proprietary Blend" as required by 21 CFR 101.36(c)(2).
2. The Stim and Trim product label fails to correctly declare the heading % DV and the % DV for each of the dietary ingredients listed as required by 21 CFR 101.36(b)(2)(iii)(A) and 21 CFR 101.36(b)(3)(iv). In particular, the percent DV for chromium is incorrectly declared. The percent must be declared to the nearest unrounded whole number (i.e. 167), as required by 21 CFR 101.36(b)(iii)(C). Furthermore, the column heading of the Supplement Facts label should be "% DV" and not "% DV*". The footnote should be "* Daily Value (DV) not established". Finally, the listing of the term "Proprietary Blend" is only used if the quantitative amount of each (b)(3)-dietary ingredient is not declared.
3. The Stim and Trim product label fails to declare the source of the synephrine extract as required by 21 CFR 101.36(d) and 101.4(g). We note that the listing of "Synephrine Extract 4%" appears to be confusing to the reader because it is not clear as to what the 4% is referring.
Your Mega Cut Fat Burner and Stim and Trim products are misbranded within the meaning of section 403(s)(2)(C) of the Act [U.S.C. § 343(s)(2)(C)] in that the labels for each product fails 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) and 101.36(d)(1). For example, your Mega Cut Fat Burner product label fails to include the part of the plant from which Guarana Extract (Paullinia cupanae), Bitter Orange (Citrus Aaurantium), Theobromine 98%, Panax Ginseng and Hoodia gordonii are derived. Likewise, the Stim and Trim product label fails to include the part of the plant from which the green coffee, cayenne, and green tea is derived.
(b)(3)(A)
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or 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. It is your responsibility to ensure that your firm complies with all requirements of the Act and all implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action by the FDA without further notice, including seizure and injunction.
In addition, we have the following labeling comment:
The Mega Cut Fat Burner product label bears the statement "Percent Daily Values are 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 as required by21 CFR 101.36(b)(2)(iii)(D) (see also 21 CFR 101.36(b)(iii)(B) and 21 CFR 101.9(c)(8)(iv)). None of those dietary ingredients is present on the label, so the statement is not permitted (see 21 CFR 101.36(a)).
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct these violations, including an explanation of each step taken to prevent these violations and copies of supporting documentation. If you cannot complete corrective actions cannot within fifteen (15) business days, state the reason for the delay and the date by which these activities will be completed.
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.
