WARNING LETTER
Hardcore Formulations MARCS-CMS 522783 —
- Recipient:
- Hardcore Formulations
United States
- Issuing Office:
- Dallas District Office
United States
| |
Office of Pharmaceutical Quality Operations, Division II 4040 N. Central Expressway, Suite 300 Dallas, Texas 75204 |
June 5, 2017
CMS Case # 522783
WARNING LETTER
VIA UPS EXPRESS
Derek L. Curtiss, Chief of Operations
Hardcore Formulations
323 Haupt
Kyle, Texas 78640
Dear Mr. Curtiss:
This is to advise you that your firm’s marketing and distribution of the products “Ultra-Sten” and “D-Zine” 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:
- Ultra-Sten: Methylstenbolone (2,17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one)
- D-Zine: Dymethazine (17b-hydroxy-2a, 17b-dimethyl-5a-androstan-3-one-azine)
“Ultra-Sten” and “D-Zine” 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: 2,17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one and 17b-hydroxy-2a, 17b-dimethyl-5a-androstan-3-one-azine. Therefore, because “Ultra-Sten” and “D-Zine” 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 product labels include claims about the effects of these products, such as the following:
Ultra-Sten
- “Rapid Size and Strength”
D-Zine
- “Rapid Size and Strength”
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 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, “Ultra-Sten” and “D-Zine” 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. §§ 33 1(d) and 355(a)]. Your sale of the new drugs “Ultra-Sten” and “D-Zine” 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, 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 “Ultra-Sten” and “D-Zine” 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 written notification should refer to the Warning Letter Number above (CMS Case # 522783).
Please address your reply to John W. Diehl, Acting Director, Compliance Branch at the FDA address provided on the first page of this letter. In addition, please submit a signed copy of your response on your firm’s letterhead to john.diehl@fda.hhs.gov.
If you have questions regarding the contents of this letter, please contact John W. Diehl at (214) 253-5288.
Sincerely,
/S/
Monica R. Maxwell
Acting Program Division Director
Office of Pharmaceutical Quality Operations, Division II
CC:
Mr. Derek L. Curtiss
Hardcore Formulations
10308 Anahuac Trail
Austin, Texas 78747
Mr. Derek L. Curtiss
Hardcore Formulations
3012 Fm 621, Suite B
San Marcos, Texas 78666-1668
VIA USPS:
Mr. Derek L. Curtiss
Genera Supplements
P.O. Box 42
Kyle, Texas 78640-0042