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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Healthy Days, Inc. 09-Nov-05

Department of Health and Human Services' logoDepartment 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

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

November 9, 2005

Roger Howard, JoAnn Howard
Healthy Days, Inc.
1 N. Forest Beach Dr.
Coligny Plaza
Hilton Head, SC 29928

Dear Mr. and Mrs. Howard:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address www.healthydaysonline.com and has determined that the product Solaray PhytoEstrogen 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 observed on your web site include:

“Soy [an ingredient in the product] … is useful for reducing the risk of hormonedependant [sic] cancers, such as breast cancer and prostate cancer. … [B]lack cohosh [an ingredient in the product] [is] used in connection with… osteoporosis…. Dong Quai [another ingredient in the product]…. can be used in connection with Fibrocystic breast disease [and] Dysmenorrhea ….”

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 Solaray PhytoEstrogen 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.

Sincerely,
/s/
Joseph R. Baca
Director
Office of Compliance
Center for Food Safety and Applied Nutrition