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

Public Health Service
Food and Drug Administration

 

Denver District Office
Denver Federal Center, Bldg. 2-C 6th Avenue & Kipling St PO Box 25087 Denver, CO 80225-0067 Telephone: 303-236-3000 FAX: 303-236-3100

January 20, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Dennis Gay, CEO
Basic Research, LLC
5742 W. Harold Gatty Dr
Salt Lake City, UT 84116

Ref. No. Den 05-06 Amended

Dear Mr Gay:

We are amending our Warning Letter of January 14, 2005 to include your products Mamralin-ARa, and TestroGel and are re-issuing the letter with a January 20, 2005 date. Your expected date of response for all five products is now extended to fifteen working days after this later date.

This letter is in reference to your firm's marketing and distribution of StriVectin-SD, StriVectin-SD Eye Cream, Dermalin-APg, Mamralin-ARa, and TestroGel. The Food and Drug Administration (FDA) has reviewed the labeling for these products, including your websites at www.kleiribecker.com and www.strivectin.com. FDA has determined that your products StriVectin-SD, StriVectin-SD Eye Cream, Dermalin-APg, Mamralin-ARa, and TestroGel are promoted with claims that cause the products to be drugs under section 201(g)(l)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 USC 321(g)(l)(C)).

As defined in section 201(g)(l)(C) of the Act, the term "drug" means articles (other than food) intended to affect the structure or function of the body. The labeling for your products includes several claims that demonstrate that these products are intended to affect the structure or function the body (structure/function claims). Examples of some of the structure/function claims observed in your products' labeling include:

StriVectin-SD:

StriVectin-SD Eye Cream (www.strivectin.com):

Dermalin-APg (www.kleinbecker.com):

Mamralin-ARa (www.kleinbecker.com)

TestroGel (www.kleinbecker.com)

Furthermore, your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are considered "new drugs" under section 201(p) of the Act. New drugs may not be legally marketed in the US without prior approval from FDA [section 505(a) of the Act].

This letter is not intended to be an ali inclusive review of all claims, labeling, or products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.

We request that you take prompt action to correct these violations. Failure to promptly correct these violations may result in enforcement action without further notice. The Act provides for the seizure of illegal products, injunctions against the manufacturer and/or distributor of illegal products, and criminal sanctions against persons responsible for causing violations of the Act.

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 stated violations, including an expIanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If the corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be implemented.

Any reply should be sent to the attention of Compliance Officer Shelly L. Maifarth at the above address.

Sincerely,
/s/
B. Belinda Collins
District Director Denver District

This page was revised on October 5, 2005.

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