Inspections, Compliance, Enforcement, and Criminal Investigations
Tip Top Vitamins 09-Nov-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|Center for Food Safety and Applied Nutrition, HFS-607 |
5100 Paint Branch Parkway
College Park, MD 20740
RETURN RECEIPT REQUESTED
November 9, 2005
Tip Top Vitamins
13430 Gulf Beach Hwy.
Pensacola, FL 32507
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.tiptopvitamins.com and has determined that the product Estro Femme™ Tablets is promoted for conditions that cause the product to be a drug 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 product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.
Examples of some of the claims for this product and its ingredients observed on your web site include:
“The Role of Soy in Preventing and Treating Chronic Disease …. [S]oy can 1) Prevent cancer at multiple sites … 9) Inhibit proliferation of cancer cells.”
“SOY AND CANCER PREVENTION … [B]reast cancer incidence may be a soy deficiency…. [A]n article was published entitled, ‘Rationale for the use of genestein-containing soy matrices in chemoprevention trials for breast and prostate cancer.’
The article stated that Oriental populations who have low rates of breast/prostate cancer consume 20-80 mg a day of genistein ….”
“Genistein and other soy components provide specific anti-cancer protection ….”
“Soy may prevent and treat some cancer in the following ways: …
2) Tyrosine kinase is an enzyme that is required for most tumor cell proliferation. Soy has been shown to safely inhibit tyrosine kinase activity, thus slowing down cancer
4) The hormones estrogen and testosterone promote cell growth throughout the body. These hormones may also cause breast/prostate cancer. Soy modulates the effects of estrogen and testosterone in a favorable way, thus reducing their risk of inducing cancer.
5) … Soy inhibits cancer cell protein synthesis ….
6) … Soy has been shown to induce cancer cells to differentiate into normal cells.”
Soy’s multiple anti-cancer mechanisms … [U]se of soy in prevention and treatment of cancer. Published papers show the potential of soy extracts to be effective in treating cancers of the colon, liver, lung, breast, prostate and some forms of leukemia.”
“Genistein And Prostate Cancer”
“Genistein And Breast Cancer …. [T]he soybean plant contains ‘friendly estrogens,’ forms of the hormone which have been shown to prevent or treat hormonally related
“Other Isoflavones Show Strong Anticancer Potential”
“Using Soy Extract In Place Of Premarin”
Furthermore, your product is not generally recognized as safe and effective for the above referenced conditions and therefore, the product is also a “new drug” 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. Your Estro Femme™ Tablets product is also misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for this drug fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
This letter is not an all-inclusive review of your website and the products that your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products [21 U.S.C. §§ 332 and 334]. You should take prompt action to correct the violations identified in this letter and any other violations of the Act. Failure to do so may result in enforcement action without further notice.
Furthermore, you should be aware that laws enforced by the Federal Trade Commission (FTC) govern claims made in advertising, including print, broadcast, websites, and other electronic media. The FTC Act, 15 U.S.C. § 41 et seq., prohibits unfair or deceptive acts and practices, including false and unsubstantiated advertising claims. It is against the law to make health claims without substantiation or to overstate the health benefits of the products you promote. Be aware that product claims can be communicated to consumers in a variety of ways, including product name, website name, product testimonials, endorsements, or use of metatags.
Please advise 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. 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 reply should be addressed to Quyen Tien, Compliance Officer, at the above letterhead address.
Joseph R. Baca
Office of Compliance
Center for Food Safety and Applied Nutrition