Inspections, Compliance, Enforcement, and Criminal Investigations

Big Dan's Fitness / Nutrition, LLC 5/25/17

 

  

Black HHS-Blue FDA Logo

 

 

 
Los Angeles District
19701 Fairchild Road
Los Angeles, CA 92612 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
 
 
May 25, 2017                                                                                                              CMS# 494626
 
 
Dan Moore
Flex Fitness Products and Big Dan’s Fitness
1337 Cedar Avenue, P.O. Box 4
Lewiston, Idaho 83501-5723
 
 
Dear Mr. Moore:
           
This is to advise you that your firm’s marketing and distribution of the products “B3AST,” “Titan,” “Titan Two,” and “Super Powers” violates the Federal Food, Drug, and Cosmetic Act (FD&C Act), as described below.

According to your product labels, your products contain the following ingredients:
  • B3AST: 19-Norandrostenediol (19-Nor); 13-ethyl-3-methoxy-gona-2,5(10)diene-17-one (Max LMG); 2,17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one (Methyl-Sten); and Carbopol
  • Titan: 7a-Methyl-estra-4-en-3, 17-dione (MENT); 6-chloro-androst-4-ene-3-one-17b-ol (Hexadrone); 13-ethyl-3-methoxy-gona-2,5(10)diene-17-one (Max LMG); 2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one (Methyl-Sten); and Carbopol
  • Titan Two: 7a-Methyl-estra-4-en-3, 17-dione (MENT); 6-chloro-androst-4-ene-3-one-17b-ol (Hexadrone); 17b-hydroxy-2a, 17b-dimethyl-5a-androstan-3-one-azine (Dymethazine); 2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one (Methyl-sten); and Carbopol
  • Super Powers: Methylsten (2,17a-methyl-5a-androsta-1-en-17b-ol-3-one (Methyl-sten))
 
“B3AST,” “Titan,” “Titan Two,” and “Super Powers” are represented as dietary supplements on their labels and other labeling; however, these products do not meet the definition of a dietary supplement in section 201(ff) of the FD&C Act [21 U.S.C. § 321(ff)]. To be a dietary supplement, a product must, among other things, “bear[ ] or contain[ ] one or more ... dietary ingredients” as defined in section 201(ff)(1) of the FD&C Act [21 U.S.C.§ 321(ff)(1)]. Section 201(ff)(1) defines “dietary ingredient” as 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 a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories.
 
The following ingredients listed on your product labels are synthetic steroids and do not constitute dietary ingredients under section 201(ff)(1) of the FD&C Act: 19-Norandrostenediol (19-Nor); 13-ethyl-3-methoxy-gona-2,5(10)diene-17-one (Max LMG); 2,17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one (Methyl-Sten); 7a-Methyl-estra-4-en-3, 17-dione (MENT); 6-chloro-androst-4-ene-3-one-17b-ol (Hexadrone); and 2,17a-methyl-5a-androsta-1-en-17b-ol-3-one. Furthermore, the product labels for your “B3AST,” “Titan,” and “Titan Two” list carbopol as an ingredient. Carbopol is a polymer used to control the release of pharmaceutical products and does not meet the definition of a dietary ingredient under section 201(ff)(1) of the FD&C Act. The product labels for your “B3AST,” “Titan,” “Titan Two,” and “Super Powers” do not declare any other ingredients. Therefore, because “B3AST,” “Titan,” “Titan Two,” and “Super Powers” do not bear or contain any dietary ingredients as defined in section 201(ff)(1) of the FD&C Act, the products are not dietary supplements under section 201(ff) of the FD&C Act.
 
Further, your website and/or product labels include claims about the effects of these products, such as the following:
 
B3AST
  • “. . . [R]apid decrease in body fat, increased vascularity, faster recovery, increased stamina and endurance, and also an increase in appetite for the 19-Nor.”
Titan
  • “. . . [G]ains in size and strength”
Titan Two
  •  “…[W]ill maximize definition, size, strength, hardness, and pumps”
Super Powers
  • “90 Caps of, Methyl Sten, RAW Power, Massive, Dry, Lean Size and Strength Gains!”

Under section 201(g)(1)(C) of the FD&C Act [21 U.S.C. § 321(g)(1)(C)], products (other than foods) that are intended to affect the structure or function of the body are defined as drugs. The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution. 21 Code of Federal Regulations (C.F.R.) § 201.128. Your products are intended to affect the structure or function of the body by, among other things, building muscle and increasing strength. Accordingly, “B3AST,” “Titan,” “Titan Two,” and “Super Powers” are drugs.
 
Moreover, these products are “new drugs,” as defined by 201(p) of the FD&C Act [21 U.S.C. § 321 (p)], because they are not generally recognized as safe and effective for their labeled uses. The introduction or delivery for introduction, or causing the introduction or delivery for introduction, of any new drug lacking an FDA-approved new drug application (NDA) is a violation of sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)]. Your sale of the new drugs “B3AST,” “Titan,” “Titan Two,” and “Super Powers” without approved NDAs violates these provisions of the FD&C Act.
 
Furthermore, your products are “prescription drugs” as defined at section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], in that because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer it. Indeed, all anabolic steroid drugs which have been approved for marketing by the FDA are limited by an approved new drug application to use under the professional supervision of a practitioner licensed by law to administer such drug. Anabolic steroids may cause serious long-term adverse health consequences in men, women, and children. These include liver toxicity, testicular atrophy and male infertility, masculinization of women, breast enlargement in males, short stature in children, adverse effects on blood lipid levels, and a potential to increase the risk of heart attack and stroke. 
 
According to section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)], a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended. 21 C.F.R. § 201.5. Prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write “adequate directions for use” for prescription drugs. FDA-approved drugs which bear their FDA-approved labeling are exempt from the requirement that they bear adequate directions for use by a layperson. But otherwise, all prescription drugs by definition lack adequate directions for use by a layperson. 21 U.S.C. § 352(f)(1); 21 U.S.C. § 353(b)(2).

In light of the fact that they are unapproved prescription drugs, the labeling of “B3AST,” “Titan,” “Titan Two,” and “Super Powers” fails to bear adequate directions for the products’ intended uses; therefore, the products are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. Because they lack the required approved application, these drugs are not exempt from this requirement under 21 C.F.R. § 201.115. Therefore, the introduction or delivery for introduction, or causing the introduction or delivery for introduction, into interstate commerce of these misbranded products violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
 
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. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
 
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 injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps 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. Furthermore, please advise this office what actions you will take to address product that you have already distributed. Additionally, if another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer.
 
Your firm’s response should be sent to:
 
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
United States Food and Drug Administration
19701 Fairchild
Irvine, California 92612
 
If you have any questions regarding any issues in this letter, please contact Mr. Lance M. De Souza, Compliance Officer via email at lance.desouza@fda.hhs.gov or by phone at (510) 337-6873 and reference unique identifier 494626.
 
 
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV

 

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