Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
Public Health Service
5100 Paint Branch Parkway
OCT 12, 2006
RETURN RECEIPT REOUESTED
1239 Stanford St., Apt. 204
Santa Monica, CA 90404
Dear Atanas Ivanov:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.herbsforliving.com and has determined that the products Trilovin DNS and Trilovin DSAO promoted for conditions that cause these products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your web site establish that these 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:
Trilovin DNS Diabetic Nutritional Support
"Clinical studies show bio active chromium with daily dosage 200mcg. - 800mcg., as Chromium yeast polypeptide provide high GTF (Glucose Tolerance Factor) to diabetics for decrease of blood sugar level between 30%-50%. . .."
Trilovin DSAO Diabetic Super Antioxidant
"Clinical studies show Alpha Lipoic Acid is a perfect antioxidant for diabetics: .. . [d]ecrease insulin resistance .. . [d]ecrease the symptoms of diabetic neuropathy .. .."
Furthermore, your products are not generally recognized as safe and effective for the above referenced conditions and therefore, they 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. These products are also misbranded within the meaning of Section 502(f)(1) of the Act, in that the labeling for these drugs fail to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your web site, we noticed that you promote other products for disease treatment and/or prevention, It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We urge you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
Please advise this office in writing, within 15 working days of receipt of this letter, as to the specific steps you have taken or will be taking to correct these violations, including the steps taken to ensure that similar violations do not recur. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Your reply should be sent to Quyen Tien, Compliance Officer, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of Enforcement (HFS-607), 5100 Paint Branch Parkway, College Park, Maryland 20740-3835.
Joseph R. Baca
Office of Compliance
Center for Food Safety and Applied Nutrition