Source: http://consumerdietreview.com/tren-xtreme-mass-xtreme-estro-xtreme-ah-89-xtreme-fda-warning/
Timestamp: 2019-04-21 14:49:31+00:00

Document:
This is to advise you that your firm’s marketing and distribution of the products “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and ‘TT-40-Xtreme” violates the Federal Food, Drug, and Cosmetic Act (the Act), as described below.
• “These benefits mean TREN-Xtreme™ delivers hardness to go with the lean mass gains.
Your products are represented as dietary supplements on their labels, on your website, and in other labeling and advertising; however, the products do not meet the definition of a dietary supplement in section 201(ff) of the Federal Food, Drug and Cosmetic Act (the Act) (21 U.S.C. § 321 (ff)). To be a dietary supplement, a product must, among other things, “bears or contains one or more … dietary ingredients” as defined in section 201(ff)(1) of the Act (21 U.S.C.§ 321(fl)(1)). Section 201(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. The substances listed as dietary ingredients on the labels of “TREN-Xtreme,” “MASS-Xtreme,” “ESTROXtreme,” “AH-89 Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT40 Xtreme” are the synthetic steroids 19-Norandrosta-4,9-diene-3,17 dione; 17a-methyletioallocholan-2-ene-17b-ol; 4-hydroxyandrostenedione (4-0HA); 5a-androstano[3,2-c]pyrazole-3-one-17B-ol-THP-ether; 2a,3a-epithio-17a-methyl-17B-hydroxy-5a-etioallocholane;Androsta-1,4-dien-3,17-dione; 17a-methyl-4-chloro-androsta-I,4-diene3B,17B-diol; and 1-androsterone, respectively. None of these steroids is 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; further, none of them is a concentrate, metabolite, constituent, extract or combination of any such dietary ingredient. Thus, because your products listed above do not bear or contain a dietary ingredient as defined in section 201(ff)(1) of the Act, the products do not qualify as dietary supplements under section 201(ff) of the Act.
Under section 201(g)(1)(C) of the 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 ofthe body by, among other things, building muscle, increasing strength, and affecting the levels of estrogens and androgens in the body. Accordingly, “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme” are drugs.
Moreover, these products are “new drugs,” as defined by 201(p) of the 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 Act (21 U.S.C. §§ 33 1(d) and 355(a)). Your sale of the new drugs “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89Xtreme,””HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme” without approved NDAs violates these provisions of the Act.
Furthermore, your products are “prescription drugs” as defined at section 503(b)(I)(A) of the Act (21 U.S.C. § 353(b)(1)(A)), in that because of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer them. 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.
According to section 502(f)(1) of the 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 “TREN-Xtreme,” “MASS-Xtreme,” “ESTRO-Xtreme,” “AH-89 Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40 Xtreme” fails to bear adequate directions for the products’ intended uses; therefore, the products are misbranded under section 502(f)(1) of the Act (21 U.S.C. § 352(f)(1)). Because they lack required approved applications, 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 Act (21 U.S.C. § 331(a)).
The claims on your website concerning the side effects of these products assert that the products minimize or do not have the potential to cause certain side effects, whereas the “Warning” statements provide otherwise. These statements render the labeling of your products false and misleading. “TREN-Xtreme,” “MASS Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme” are therefore misbranded under section 502(a) of the Act (21 U.S.C. § 352(a)). The introduction or delivery for introduction into interstate commerce of these misbranded products violates section301(a) of the Act (21 U.S.C. §33I(a)).

References: § 321
 § 321
 § 201
 § 321
 § 353
 § 352
 § 201
 § 352
 § 353
 § 352
 § 201
 § 331
 § 352
 §33