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.
Vendor, Owner
address of vendor
Dear Mr.
Vendor:
On February 16 - 17, 2010, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at
address. We have also reviewed your firm's website...
This letter concerns your firm's marketing of the following products:
Brand A Piracetam,
Brand B Piracetam . . .
Piracetam Containing Products
Your firm markets your piracetam products, "
Brand A Piracetam"
and "
Brand B 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 "
Brand A Piracetam"
and "
Brand B 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
Brand A Piracetam and
Brand B 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:
Brand A Piracetam
• "Piracetam supports memory and concentration, overall well-being, cardiovascular health, and helps reduce stress and fatigue."
Brand B Piracetam
• "Piracetam supports memory and concentration, overall well-being, cardiovascular health, and helps reduce stress and fatigue."
The claims listed above make clear that "
Brand A Piracetam"
and "
Brand B 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 "
Brand A Piracetam"
and "
Brand B Piracetam." Your sale of these products without approved applications violates these provisions of the Act.
. . .
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
* 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."
