Unlimited Nutrition 8/30/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Atlanta District Office 60 Eighth Street N.E. Atlanta, GA 30309

August 30, 2010
 

WARNING LETTER
10-ATL-19

HAND DELIVERED

Mr. Mike McCandless, Owner
Unlimited Nutrition
Scivation, Inc., President
1130 Cherry Lane
Graham, NC 27253

Dear Mr. McCandless:

On February 16 - 17, 2010, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1130 Cherry Lane, Graham, NC 27253. We have also reviewed your firm's website, www.smartpowders.com.

This letter concerns your firm's marketing of the following products: "Smart Powders Piracetam," "Primaforce Piracetam," "Advanced Muscle Science Arom-X," "Advanced Muscle Science 4-AD UTT," "G.E.T ArimaDex," "iForce Nutrition Reversitol," and "Fizogen Off Cycle II Hardcore." These products are marketed in violation of the Federal Food, Drug, and Cosmetic Act (the Act) as described below.

Piracetam Containing Products

Your firm markets your piracetam products, "Smart Powders Piracetam" and "Primaforce Piracetam" as dietary supplements; however, both products are excluded from the definition of a "dietary supplement" under section 201(ff)(1) of the Act, 21 U.S.C. § 321(ff)(1). 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 Act. Section 201(ff)(1) of the Act 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 only substance listed as a dietary ingredient on the labeling for your "Smart Powders Piracetam" and "Primaforce Piracetam" products is piracetam. Piracetam is not 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, piracetam is not a concentrate, metabolite, constituent, extract or combination of any such dietary ingredient. Thus, because your "Smart Powders Piracetam" and "Primaforce Piracetam" products do not bear or contain any dietary ingredients as defined in section 201 (ff)(1) of the Act, these products do not qualify as dietary supplements under section 201(ff) of the Act.¹

Your website and labeling include statements such as the following:

Smart Powders Piracetam

• "Piracetam supports memory and concentration, overall well-being, cardiovascular health, and helps reduce stress and fatigue."

Primaforce Piracetam

• "Piracetam supports memory and concentration, overall well-being, cardiovascular health, and helps reduce stress and fatigue."

The claims listed above make clear that "Smart Powders Piracetam" and "Primaforce Piracetam," are intended to affect the structure or any function of the body of man or other animals. Accordingly, these ·products are drugs, under section 201(g)(1)(C) of the Act, 21 U.S.C. § 321(g)(1)(C), because they are not foods and they are intended to affect the structure or any function of the body. Moreover, these products are new drugs as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling.

Under sections 301(d) and 505(a) of the Act, 21 U.S.C. § 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA approved application is in effect for it. There are no approved applications for "Smart Powders Piracetam"
and "Primaforce Piracetam." Your sale of these products without approved applications violates these provisions of the Act.

Body Building and Sport Performance Products

In addition, your firm's body building and sport performance products "Advanced Muscle Science Arom-X," "Advanced Muscle Science 4-AD UTT," "G.E.T ArimaDex," "iForce Nutrition Reversitol," and "Fizogen Off Cycle II Hardcore" are unapproved and misbranded drugs under the Act.

Your website, www.smartpowders.com. states that your products contain the following ingredients:

• Advanced Muscle Science Arom-X: 1,4,6-etioallocholan-dione
• Advanced Muscle Science 4-AD UTT: 3,17-keto-etiochol-triene
• G.E.T ArimaDex: 3,17-keto-etiochol-triene
• iForce Nutrition Reversitol: 6-Etioallochol-1 ,4-Diene-3,17-Dione
• Fizogen Off Cycle II Hardcore: 3 17 keto etiochol triene

The above-listed ingredient names are all synonyms for the same ingredient, commonly known as "ATD." "ATD" is an aromatase inhibitor. FDA is unaware of evidence that ATD occurs in vivo in humans or animals.

Your firm markets "Advanced Muscle Science Arom-X," "Advanced Muscle Science 4-AD UTT," "G.E.T ArimaDex," "iForce Nutrition Reversitol," and "Fizogen Off Cycle II Hardcore" as dietary supplements. 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 Act. Section 201(ff)(1) of the Act 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. ATD is not 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, ATD is not a concentrate, metabolite, constituent, extract or combination of any such dietary ingredient. Therefore, ATD is not a dietary ingredient as defined in section 201 (ff)(1) of the Act, 21 U.S.C. § 321(ff)(1).

Your website includes statements such as the following:

Advanced Muscle Science Arom-X

• "Anti-estrogen complex."
• ''Natural testosterone booster."
• "Libido enhancer."
• "Arom-X is scientifically formulated to suppress estrogen production and restore natural testosterone output while acting as a strong libido enhancer."

Advanced Muscle Science 4-AD UTT

• "4-AD UTT is a unique anabolic solution pro-hormone that converts at a high rate of testosterone (sic)."
• "[W]ill give you better strength and size increases than the old testosterone precursors."

G.E.T ArimaDex

• "A proprietary blend of 7 ingredients including an estrogen blocker ... that have all been shown to increase or maintain testosterone levels."

iForce Nutrition Reversitol

• "By regulating the production and levels of Testosterone, Estrogen, LH, and Cortisol an athlete will ensure PEAK. Performance Reversitol promotes the optimal Hormone Regulation for applying Maximum FORCE!"
• "Usage for promoting hormonal regulation ...."

Fizogen Off Cycle II Hardcore

• "Off Cycle" and "If you are subject to performance enhancing drug testing, do not use this product unless cleared by your sanctioning body"

The statements above make clear that "Advanced Muscle Science Arom-X," "Advanced Muscle Science 4-AD UTT," "G.E.T ArimaDex," "iForce Nutrition Reversitol," and "Fizogen Off Cycle II Hardcore" are intended to affect the structure or function of the body. Accordingly, these products are drugs under section 201(g)(1)(C) of the Act, 21 U.S.C. § 321(g)(1)(C).

As mentioned above, your firm markets "Advanced Muscle Science Arom-X," "Advanced Muscle Science 4-AD UTT," "G.E.T ArimaDex," "iForce Nutrition Reversitol," and "Fizogen Off Cycle II Hardcore" as dietary supplements. Under section 201(g)(1) (last sentence), the structure/function claims made for a dietary supplement must be made in accordance with section 403(r)(6) of the Act, 21 U.S.C. § 343(r)(6), or the product is subject to regulation as a drug. Section 403(r)(6) of the Act, 21 U.S.C. § 343(r)(6), authorizes claims that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body, or that characterize the way in which a nutrient or dietary ingredient maintains the structure or function of the body.

However, the claims quoted above for your body building and sport performance products, "Advanced Muscle Science Arom-X," "Advanced Muscle Science 4-AD UTT," "G.E.T ArimaDex," "iForce Nutrition Reversitol," and "Fizogen Off Cycle II Hardcore," do not describe the effects of nutrients or dietary ingredients in the products. Rather, the claims made for each product are made for the product as a whole and relate to its "ATD" content. Since "ATD" is not a nutrient or dietary ingredient, claims about improvement of the structure or function of the body do not conform to section 403(r)(6) of the Act, 21 U.S.C. § 343(r)(6). Accordingly, the claims for "Advanced Muscle Science Arom-X," "Advanced Muscle Science 4-AD UTT," "G.E.T ArimaDex," "iForce Nutrition Reversitol," and "Fizogen Off Cycle II Hardcore" render them drugs within the meaning of section 201(g)(1)(C) of the Act, 21 U.S.C. § 321(g)(1)(C).

Moreover, the above-listed body building and sport performance 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 use under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of "Advanced Muscle Science Arom-X," "Advanced Muscle Science 4-AD UTT," "G.E.T ArimaDex," "iForce Nutrition Reversitol," and "Fizogen Off Cycle II Hardcore" without approved applications violates these provisions of the Act.

Furthermore, "Advanced Muscle Science Arom-X," "Advanced Muscle Science 4-AD UTT," "G.E.T ArimaDex," "iForce Nutrition Reversitol," and "Fizogen Off Cycle II Hardcore" are prescription drugs as defined at section 503(b)(1)(A) of the Act, 21 U.S.C. § 353(b)(1)(A), because, in light of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to use, they are not safe for use except under the supervision of a practitioner licensed by law to administer them. Indeed, all aromatase inhibitors that 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). Under 21 C.F.R. § 201.5, "adequate directions for use" means directions under which a layman can use a drug safely and for the purposes for which it is intended. 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. See 21 C.F.R. §§ 201.100(c)(2) and 201.115. Because there are no FDA-approved applications for your firm's "Advanced Muscle Science Arom-X," "Advanced Muscle Science 4-AD UTT," "G.E.T ArimaDex," "iForce Nutrition Reversitol," and "Fizogen Off Cycle II Hardcore" products, their labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(t)(1). 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 issues and violations cited in this letter are not intended to be an all-inclusive statement of the 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 all products marketed by your firm comply with the Act and its implementing 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 (15) working days of receipt of this letter, please notify this office in writing of the specific steps that 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 corrections. 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 product is not the manufacturer, please include the name of your supplier in addition to the manufacturer.
 

Please send your reply to Derek C. Price, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, N.E., Atlanta, GA 30309. If you have any questions about the content of this letter, please contact Mr. Price at 404-253-2277.

Sincerely
/S/
John Gridley
District Director
Atlanta District Office

¹ We note that in 2003, (b)(4) submitted a New Dietary Ingredient Notification (NDIN) for piracetam, naming your firm as the distributor, pursuant to section 413(a)(2) of the Act, 21 U.S.C. §350b. Section 413(a)(2) of the Act requires premarket notification to CFSAN prior to the introduction of a new dietary ingredient into interstate commerce. The NDIN is required to contain infonnation which is the basis for the conclusion that a dietary supplement containing such new dietary ingredient will reasonably expected to be safe. CFSAN's response letter
to Mr. (b)(4) NDIN, which was issued on January 9, 2004, stated that piracetam is "not a dietary ingredient."
 

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