Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration

 

New York District
850 Third Avenue
Brooklyn, New York 11232-1593

REGULATORY LETI'ER

JUN 11, 1987

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Josephine Perricone
President
Bio-Botanica Inc.
75 Commerce Drive
Hauppauge, New York 11788

21-NYK-87

Dear Ms. Perricone:

This letter concerns the marketing of "Nature’s Answer" brand Homeopathic Herpes Cream by your firm.

The label promotes this "Herpes Cream" product for relief of, among other things, "skin eruptions caused by Herpes viruses".

Because this label includes statements which represent and suggest that this article is intended to be used in the cure, mitigation, treatment or prevention of disease, or is intended to affect the structure or any function of the body of man, this product is a drug within the meaning of section 201 (g) of the Federal Food, Drug, and Cosmetic Act. Further, we an· unaware of any substantial scientific evidence which documents that this drug is generally recognized as safe and effective against the herpes virus. Accordingly, marketing of this drug is a violation of the Federal Food, Drug, and Cosmetic Act, as follows:

Section Brief Description

502(a) The aforesaid article of drug is misbranded in that its labeling is false am misleading by representations and suggestions that there is substantial scientific evidence to, establish that the article is safe and effective against the herpes virus.

502(f)(1) The article of drug is misbranded in that its labeling fails to bear adequate directions for use in the treatment of the herpes virus condition and it is not exempt from this requirement under regulation 21 CFR 201.115 since the article is a new drug within the meaning of section 201 (p) and no approval of an application filed pursuant to section 505 (b) is effective for this drug.

  The article of drug, "Nature's Answer" brand Homeopathic Herpes Cream is further misbranded in that its labeling does not contain adequate directions for use as this term is defined in 21 CFR 201.5 since the conditions for which it is offered are not amenable to self diagnosis and treatment by the laity therefore adequate directions for use cannot be written under which the layman can use this drug safely and for the purposes for which it was intended.

505(a) The article, "Nature's Answer" brand Homeopathic Herpes Cream is a drug within the meaning of section 201 (g) of the Act which may not be introduced or delivered for introduction into interstate commerce under section 505 {a} of the Federal Food, Drug, and Cosmetic Act, since it is a new drug within the meaning of section 201 (p) of the Act and no approval of an application filed pursuant to section 505 (b) is effective for such drug.

The violations listed above are not intended to be all-inclusive. It is your responsibility to assure that all other products distributed by your firm are not similarly misbranded by unsubstantiated therapeutic claims or that they are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act.

We request that you take prompt action to correct the above violations. If such action is not taken, the Food and Drug Administration is prepared to invoke the regulatory sanctions provided under the law. These include seizure and/or injunction.

In addition to the above noted violations, over-the-counter drugs which you distribute that are intended for systemic absorption, such as "Nature's Answer brand Acne Remedy and Allergy Remedy, are misbranded under Section 502(f)(2) of the Act in that they do not contain the appropriate "warning" statement as specified in 21 CFR 20l.63(a).

Please notify us in writing within 10 days of the receipt of this letter of your intentions regarding the continued marketing of the above "Herpes Cream" product. Your reply should be addressed to Mr. Clarence L. Waltrous, Director, Compliance Branch, at the above address.

Sincerely yours,

/s/______________________
JOSEPH J. FALINE
District Director
Food and Drug Administration
New York District

JJF:FJR/ag

This page was posted on August 23, 2009.

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