Inspections, Compliance, Enforcement, and Criminal Investigations

Hi-Tech Pharmaceuticals, Inc. 4/22/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

 

WARNING LETTER
APR 22, 2015 
VIA ELECTRONIC MAIL
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
 
Jared Wheat, CEO
Hi-Tech Pharmaceuticals, Inc.
6015-B Unity Drive
Norcross, GA 30071
 
Re: 456722
 
Dear Mr. Wheat:
 
This letter concerns your products Fastin®-XR, Fastin® Rapid Release, and Lipodrene® Extended Release, which are labeled and/or offered for sale as dietary supplements. Your product labeling lists the substance R-beta-methylphenethylamine as a dietary ingredient in the form of an extract of Acacia rigidula (leaves). This ingredient is also called, among other names, Beta-methylphenethylamine, βMePEA, or BMPEA (hereinafter referred to as BMPEA).
 
Under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)(1)], a dietary ingredient is a vitamin; mineral; herb or other botanical; amino acid; 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 the preceding substances. BMPEA is not a vitamin, a mineral, an herb or other botanical, or an amino acid. In addition, BMPEA is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Finally, BMPEA is not a concentrate, metabolite, constituent, extract, or combination of a vitamin; mineral; herb or other botanical; amino acid; or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Although your product labeling asserts that BMPEA is an extract of the botanical Acacia rigidula, we are aware of no evidence to support an assertion that BMPEA is, in fact, a constituent of this botanical. Accordingly, BMPEA is not a dietary ingredient within the definition set forth in section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)]. Declaring BMPEA in your product labeling as a dietary ingredient causes your products marketed as dietary supplements to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading in any particular.[1]
 
We request that you take prompt action to correct the violation cited above, as well as any other violations associated with your Fastin®-XR, Fastin® Rapid Release, and Lipodrene® Extended Release products or other products marketed by your firm that contain BMPEA.  It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
 
Failure to immediately cease distribution of your Fastin®-XR, Fastin® Rapid Release, and Lipodrene® Extended Release products, and any other products you market that contain BMPEA, could result in enforcement action by FDA without further notice.  Sections 302 and 304 of the Act provide for seizure of violative products and injunction against the manufacturers and distributors of violative products [21 U.S.C. §§ 332 and 334]. 
 
Additionally, BMPEA is not approved as a food additive or prior sanctioned for use in dietary supplements.  Further, FDA’s review of this substance does not identify a basis to conclude the substance is GRAS for use in food. If you contend that this substance is GRAS for use in food, please provide your basis for concluding that BMPEA is GRAS for use in dietary supplements, including supporting data or other documentation.
 
We request that you advise us in writing, within 15 days of receipt of this letter, as to the specific steps that have been or will be taken to correct these violations, including any steps taken with respect to product currently in the marketplace. Your response should also include an explanation of each step taken to ensure that similar violations do not recur, as well as documentation to support your response. Your written reply should be directed to Mabel Lee, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Ms. Lee at BMPEATaskforce-CFSAN@fda.hhs.gov.
 
Sincerely,
/S/                                                                       
William A. Correll
Director
Office of Compliance
Center for Food Safety
   and Applied Nutrition
 
cc:  
Via Electronic Mail
Via Overnight Delivery
Return Receipt Requested
E.Vaughn Dunnigan, P.C.
2897 N. Druid Hills Rd., Ste. 142
Atlanta, GA 30329


[1] To the extent that any of these products also contain 1,3-Dimethylamylamine HCl (DMAA) or its chemical equivalent, they are also adulterated as alleged in the seizure action, United States v. Undetermined quantities of all articles of finished and in-process foods, etc., C.A. No. 1:13-cv-3675 (N.D. Ga.).

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