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U.S. Department of Health and Human Services

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Enforcement Actions

Biotivia America 15-Oct-07

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

Public Health Service
Food and Drug Administration

 

College Park, Maryland 20740


WARNING LETTER

CERTIFIED MAIL
RECEIPT REQUESTED

OCT 15, 2007

Biotivia America
Biotivia Bioceuticals,
I River Place, Suite 1001
New York, NY 10036

Re: CFSAN-OC-08-01

Dear Ms. Tonkin:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address http://www.bioflu.com and has determined that the products "Bioforte 500" and "Bioflu Vital" 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 therapeutic claims on your web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. Examples of some of the claims observed on your web site include:

Bioforte 500

• "Anti-Cancer. Anti-Cholesterol. No wonder Resveratrol is popular worldwide."

• "Studies done by international researchers since 1994 have shown resveratrol to be an effective anti-cholesterol, anti-viral, anti-dementia, as well as a[n] ... anti-cancer, anti-heart disease,... blood pressure and blood sugar-normalizing agent."

• "[H]as been hailed as a miracle treatment for everything from obesity ... to cancer and diabetes."

• "Cancer Prevention -Resveratrol is the only natural product with such strong evidence to show it stops cancerous cell development at various stages. A study published in the prestigious journal Science showed that Resveratrol blocks the proliferation of cancerous cells during three important stages of development. A study in which mice were given Resveratrol for more than 18 weeks showed a reduction in skin tumors of 98%! Other research has demonstrated that, in some cases, it improved the results of chemotherapy ...."

• "The World Health Organization suggests that Resveratrol single-handedly reduces cardiovascular risk by 40%!"

Bioflu Vital

• "Kills 100% of Influenza A and B, Avian Flu, and HIV viruses in university in-vitro studies"

• "Help your body to fight off Colds, Influenza and other Airborne Viruses."

• "A safe, all-natural alternative to Tamiflu®"

• "Traditional Chinese flu ... remedy for over 2000 years"

• "The potent polyphenols and anti oxidants in Bioflu have been shown in university studies to dramatically reduce the severity and duration of viral infections. If taken at the first sign of infection Bioflu can provide immediate immune support and help you to fight off the flu symptoms."

• "Take Bioflu to lessen the effects of Influenza A & B ...."

• "Bioflu may also be the best natural defense against emerging drug-resistant infections, such as extreme tuberculosis and MRSA [Methicillin-resistant Staphylococcus aureus]."

• "The safe natural way to protect against Viruses."

In addition, the name "Bioflu Vital" suggests that your product is intended for use in treating or preventing flu.

The claims on your website about disease uses of Bioforte 500 and Bioflu Vital are supplemented by the disease-specific metatags you use to bring consumers to your website through Internet searches. The metatags include "anti-cancer," "viruses," "influenza," and "bird flu."

Further, your website has pages captioned "Bioforte Studies" and "Bioflu Studies" where published articles on human and animal studies of ingredients in Bioforte 500 and Bioflu Vital are listed. Each article name links to an abstract of the publication on a separate page, and some also link to the full text of the publication. Many of the publications listed on the "Bioforte Studies" and "Bioflu Studies" pages of your site concern therapeutic uses of active ingredients in your products. 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 product is considered 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 that the product is useful for treatment or prevention of a disease.

The following are examples of publications that are cited on your website and used to promote Bioforte 500 for treatment or prevention of various diseases. Below your online abstract of each of the first two publications, you include the statement "Note: Resveratrol is an active ingredient of Bioforte."

• "Anticancer activity of resveratrol on implanted human primary gastric carcinoma cells in nude mice."

• "Effect of resveratrol on alcohol-induced mortality and liver lesions in mice."

• "Resveratrol-a boon for treating Alzheimer's disease"

The following are examples of publications that are cited on your website and used to promote Bioflu Vital for treatment or prevention of various diseases. Below your online abstract of each publication, you include the statement "Note: Elderberry extract is an active ingredient of Bioflu."

• "Black elderberry extract may reduce flu symptoms."

• "Inhibition of proinflammatory activities of major periodontal pathogens by aqueous extracts from elder flower (Sambucus nigra)."

Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are also "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.

This letter is not an all-inclusive review of your website and the products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and FDA regulations.

The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.

Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be directed to Quyen T. Tien, Compliance Officer, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of Enforcement (HFS-608), 5100 Paint Branch Parkway, College Park, Maryland 20740-3835.

Sincerely,

Joseph R. Baca
Director
Office of Compliance
Center for Food Safety
And Applied Nutrition