Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
 

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128

September 11, 2008

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Al Discount Vitamins
3180 NW 206
Edmond, OK 73003

WARNING LETTER
2008-DAL-WL-22

Dear Sir or Madam:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.a1discountvitamins.com and has determined that the products "C-1000," "Colloidal Silver," "Graviola," "Red Raspberry Extract," "Juice Complex," "Lycopene," and "Pomegranate" 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)(13)]. The therapeutic claims on your website 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:

C-1000

Colloidal Silver

Graviola (650 mg)

Red Raspberry Extract

In addition, the "Graviola & Ellagic Acid" page of your website lists several claims that promote your "Graviola" and "Red Raspberry Extract" products together for the treatment or prevention of cancer. Examples of some of the claims observed on this page include:

Juice Complex

Lycopene

Further, the "Lycopene" product page of your website www.a1discountvitamins.com cites numerous articles about studies of the "lycopene" ingredient used in your products. These articles concern the use of this ingredient for treatment or prevention of cancer.

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 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 reference citations used to market your "Lycopene" product for disease treatment and prevention on your website:

Pomegranate

Finally, your website promotes the products listed above for cancer treatment or prevention through the "Cancer Fighting Products" link on the home page of your website as well as the "Cancer Supplements," "Natural Cancer Products," and "Prevent Cancer Products" links in the "Products Menu" listing on the left side of each page. Clicking on any of these links brings you to a product directory where these products are offered for sale. You also promote "Colloidal Silver," "Graviola," "Red Raspberry Extract," "Juice Complex," "Lycopene," and "Pomegranate" on the "Cancer Prevention" page of your website.

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the 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. Your products "C1000," "Colloidal Silver," "Graviola," "Red Raspberry Extract," "Juice Complex," "Lycopene," and "Pomegranate" are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fails 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 website, we noticed that you were promoting these products for treatment and/or prevention of diseases other than cancer and that you were also promoting 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 advise 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.

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. The Act authorizes the seizure of, illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].

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 Sherrie L. Krolczyk, Compliance Officer, at the letterhead address.

Sincerely,

/S/

Reynaldo R. Rodriquez, Jr.
Dallas District Director

This page was posted on July 19, 2010.

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