Source: https://www.casewatch.net/fdawarning/prod/2009/americell.shtml
Timestamp: 2019-04-24 01:56:58+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.
TREN-Xtreme: 19-Norandrosta-4,9-diene-3,17 diene, which you state is "[s]imilar to Trenbolone"
MASS Xtreme: 17α-methyl-etioallocholan-2-ene-17b-01, which you state is "[s]imilar to Methyl Testosterone"
AH-89-Xtreme: 5a-androstano[3,2-c]pyrazole-3-one-17B-01-THP-ether, which you state is "[s]imi1ar to Stanozolol"
MMA-3 Xtreme: Androsta-1 ,4-dien-3, 17-dione, which you state is "similar to Boldenone (Equipoise)"
VNS-9 Xtreme: 17a-methyl-4-chloro-androsta-1,4-diene-3B, 17B-diol, which you state is "[s]imilar to Turinabol"
TT-40-Xtreme: 1-androsterone, which you state is "very similar to 1-testosterone" and "[c]onverts to 1-Testosterone"
"TREN-Xtreme™ binds to the androgen receptor 300% better than testosterone. This high androgen receptor affinity means TREN-Xtreme™ delivers quality gains in muscle mass and strength."
"These benefits mean TREN-Xtreme™ delivers hardness to go with the lean mass gains.
"For maximum results combine TREN-Xtreme™ with proper nutrition and intense training to build high quality muscle mass, solid strength gains and maximum hardness. Get the hard body you want with TREN-Xtreme™!"
Men Wanting Dry Lean Gains & Hardness"
"MASS-Xtreme™ is perfect if you are focused on adding muscle mass, power and strength to your physique."
"MASS-Xtreme™ is a potent anabolic and has low androgenic activity. In fact, tests show an anabolic activity that is two to five times that of methyltestosterone with an androgenic activity that is 0.4 to 0.6 that of methyltestosterone. The chemical structure of MASS-Xtreme™ makes it androgen receptor specific while also actively stimulating IGF-1 and myostatin mRNA expression. So you get a lot of mass building effects without a lot of unwanted androgenic effects."
"What you do get are significant and noticeable gains in muscle mass and strength."
"Before you know it you'll notice the gains in the gym and the mirror. Use the original mass building supplement, MASS-Xtreme™!"
Men Wanting More Muscle Mass, Power & Strength"
"... ESTRO-Xtreme™, the ultimate in Estrogen management and control. Estrogen can cause fat gain, gyno, water retention and bloating, all of which lead to a smooth nonmuscular appearance. Controlling estrogen is the key to developing and maintaining a lean, hard, muscular physique."
"ESTRO-Xtreme™ prevents the production of estrogen by irreversibly binding and inactivating the aromatase enzyme, preventing the conversion of androgens to estrogens."
"ESTRO-Xtreme™ decreases estrogen production as well, which means reduced body fat gains, less water retention, bloating ...."
"4-0HA also decreases the receptor counts for both estrogen and progesterone. ESTRO-Xtreme™ blocks the conversion of androgens to estrogens and it minimizes the effect of existing estrogens by decreasing the number of receptors for estrogen and progesterone. You get two estrogen blocking effects in one fantastic product!"
Men Wanting to Manage and/or Lower Estrogen"
"... AH-89-Xtreme™ is best when used for achieving a leaner and harder appearance."
"This means mass gains will be minimal, while hardening effects will be more prominent."
"Only mildly anabolic, AH-89-Xtreme™ has greater androgenic effects."
"Use AH-89-Xtreme™ to take your body to new levels of lean hard muscle!"
Men Wanting to be Leaner and Harder"
"The compound in HMG-Xtreme™ binds to muscle androgen receptors causing increased protein synthesis rate while also binding muscle stem cells causing them to become activated. Together these two anabolic actions increase potential muscle repair and growth."
"Besides the anabolic effect, HMG-XtremeTM is a tissue specific estrogen blocker. This means that HMG-Xtreme™ only binds to 17B-estradiol receptors in certain tissues such as mammary (breast). This can significantly reduce and/or even reverse gynecomastia caused by temporary elevations in estrogen.HMG-Xtreme™ specifically blocks estrogen in mammary (breast) tissue resulting in reduced size, even shrinking the tissue to pre-gynecomastia levels."
"Superior muscle gains and estrogen management in one product!"
Men Wanting Muscle Gains & Estrogen Management"
"One of the main effects of MMA-3-Xtreme™ is an increased appetite, which may be the main reason for the excellent mass gains seen with its use."
"Build the muscle size you've been looking for with MMA-3-Xtreme™."
Men Wanting More Muscle Mass"
"Similar in structure to oral Turinabol, VNS-9-Xtreme™ is ideal if your goal is to obtain solid muscle mass and strength gains. VNS-9-Xtreme™ works directly upon the anabolic receptors so there is no conversion needed."
"The compound in VNS-9-Xtreme™ has a high anabolic effect and a low androgenic effect."
Men Wanting Solid Muscle & Strength"
"If you are seeking to gain muscle mass along with strength then look no further than TT-40-Xtreme™."
"You can expect mild estrogen related effects along with excellent anabolic benefits. The muscle gains from TT-40-Xtreme™ are going to be slightly more watery than some non-estrogen forming compounds, while strength gains should be superior."
Combined with proper nutrition and intense training, TT-40-Xtreme™ will provide the anabolic/androgenic stimulus for muscle mass gains and strength increases. Lift heavier, increase your strength, and add more muscle to your physique with TT-40Xtreme™!"
Men Wanting More Size & Strength 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)).
WARNING: Consult a Physician before using this product if you have, or have a family history of, prostate enlargement/cancer, heart disease, high cholesterol, kidney, liver, or hormone problems or if you are using any other dietary supplement, prescription or OTC drug. Exceeding recommended serving may cause adverse health effects. Possible side effects include acne, hair loss, facial hair growth (women), aggressiveness, irritability, and increased levels of estrogen. Discontinue use and call a Physician immediately if you experience adverse events.
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)).
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.
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 0 f 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.
The Act authorizes injunctions against manufacturers and distributors of illegal products, and the seizure of such products, under sections 302 and 304 (21 U.S.C. §§ 332 and 334). In addition, there is criminal liability for all violations of the prohibited acts described in section 301 of the Act (21 U.S.C. § 331). You should take prompt action to correct the violations cited in this letter and to prevent their recurrence. Failure to do so may result in enforcement action without further notice. Other federal agencies may take this Waming Letter into account when considering the award of contracts.
Within fifteen working days of the receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the cited 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. Address your reply to the U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070, Attention: Carl Lee, Compliance Officer. You may reach Carl Lee by phone at (510) 337-6737, or email at carl.lee@fda.hhs.gov.

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