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

Public Health Service
Food and Drug Administration
 
New York District     
158-15 Liberty Avenue
Jamaica, NY 11433

 

May 29, 2013                                                                                 
 
WARNING LETTER NYK-DO 2013-20
 
 
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
 
Nature’s Answer
Attn: Mr. Frank D’Amelio, Sr.
75 Commerce Drive
Hauppauge, NY 11788
 
Dear Mr. D’Amelio:
 

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website, www.naturesanswer.com, in April 2013 and has determined that your products “Hi-B Homocysteine,” “Goldenseal Root,” “Nature’s Answer® Bio-Flavonoids with Rosehip,” “Immune BoostTM,” “Gingko Leaf,” “Male Complex,” “Sambucus Nigra,” “Bio-Strath,” “Greens Today for Women,” and “Greens Today for Men,” are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The claims on your website establish that these products are drugs because they   are intended for use in the cure, mitigation, t

reatment, or prevention of disease. The marketing of your products with these claims violates the Act.

 
On the webpage titled, “Cardiovascular Health”:
 
 
On the page titled, “Colds & Flu”:
 
 
On the page titled, “Immune Health”:
 
 
On the page titled, “Memory”:
 
 
On the page titled, “Men’s Health”:
 
 
In addition, your website contains disease claims in the form of testimonials, for example:
 
On the page titled, “Nature’s Answer Customer Testimonials”:
 
 
In addition, when scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a dietary supplement is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.  The following are examples of publications that are used to market your product Hi-B Homocysteine for disease treatment and prevention on your website and are thus evidence of your product’s intended use as a drug:
 
 
Your products “Hi-B Homocysteine,” “Goldenseal Root,” “Nature’s Answer® Bio-Flavonoids with Rosehip,” “Immune BoostTM,” “Gingko Leaf,” “Male Complex,” “Sambucus Nigra,” “Bio-Strath,” “Greens Today for Women,” and “Greens Today for Men”are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
 
Furthermore, your products “Hi-B Homocysteine,” “Ginkgo Leaf,” “Male Complex,” “Sambucus Nigra,” “Bio-Strath,” “Greens Today for Women,” and “Greens Today for Men” are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products and their labeling. 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 your firm complies with all requirements of federal law and FDA regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
 
Within fifteen (15) working days of receipt of this letter, please notify this office in writing as to the specific steps 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 actions within fifteen working days, state the reason for the delay and the time within which you will complete the corrections.
 
Please send your reply to the attention of Lillian C. Aveta, Compliance Officer, Food and Drug Administration, 158-15 Liberty Ave., Jamaica, NY 11433. If you have any questions regarding this letter, please contact Ms. Aveta at 718-662-5576.
 
 
Sincerely yours,
/S/ 
Ronald M. Pace
District Director
New York District
 
 
cc:        Michael Tagner
Bio-Botanica, Inc.
85 Commerce Drive
Hauppauge, NY 11788
 

This page was posted on November 29, 2014.

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