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  5. NeuroScience Solutions, Inc. dba NeuroScience - 576310 - 04/10/2019
  1. Warning Letters

WARNING LETTER

NeuroScience Solutions, Inc. dba NeuroScience MARCS-CMS 576310 —

Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Gottfried Kellermann
NeuroScience Solutions, Inc. dba NeuroScience

373 280th Street
Osceola, WI 54020
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

5001 Campus Drive
College Park, MD 20740-3835
United States

WARNING LETTER

 

 

VIA OVERNIGHT DELIVERY

RETURN RECEIPT REQUESTED

 

April 10, 2019

 

NeuroScience

Attn: Gottfried Kellermann

373 280th Street

Osceola, WI 54020

 

Re: 576310

 

Dear Mr. Kellermann:

This letter concerns your product Kavinace which is labeled and/or offered for sale as a dietary supplement. Your product labeling lists the substance 4-amino-3-phenylbutyric acid HCl as a dietary ingredient. This ingredient is also called, among other names, phenibut, fenibut, phenigam, PhGaba, phenigamma, phenygam, 4-Amino-3-phenylbutanoic acid, β-(Aminomethyl)benzenepropanoic acid, beta-(Aminomethyl)hydrocinnamic acid, and β-phenyl-γ-aminobutyric acid (hereinafter referred to as phenibut).

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; a mineral; an herb or other botanical; an amino acid; a 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. Phenibut is not a vitamin; a mineral; an herb or other botanical; an amino acid; a 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. Because phenibut does not fit in any of the dietary ingredient categories under section 201(ff)(1) of the Act, it is not a dietary ingredient as defined in the Act. Declaring phenibut in your product labeling as a dietary ingredient causes your product 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]

The violation cited in this letter is 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 of the violation identified above and for preventing its recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to correct the violation cited in this letter. Failure to promptly correct this violation may result in legal action without further notice, including, without limitation, seizure and/or injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violation. Include an explanation of each step being taken to prevent the recurrence of the violation, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. 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.

Your written reply should be directed to Shawn Goldman, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Mr. Goldman at Shawn.Goldman@fda.hhs.gov.

 

Sincerely,

/S/                                                                       

William A. Correll

Director

Office of Compliance

Center for Food Safety and Applied Nutrition

 

[1] This warning letter does not address whether phenibut can be lawfully marketed in dietary supplements as non-dietary ingredients. For non-dietary ingredients intended for use in dietary supplements to be lawfully marketed in a dietary supplement, the substance must be used in accordance with a food additive regulation or be generally recognized as safe (GRAS) for its intended use (see section 201(s) of the Act (21 U.S.C. § 321(s)).

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