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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Global Internet Alliance 18-Feb-04

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145



February 18, 2004

Ref: 2004-DAL-WL-12

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Tony Stires
Global Internet Alliance
4541 West End
Corpus Christi, Texas 78411

Dear Mr. Stires:

This letter concerns T-10 HGH, Human Growth Hormone, marketed by your firm as shown on your Internet site www.ezsuoer.com. According to information on this site, T-10 HGH is being sold as an anti-aging treatment regimen. Ordering instructions for the drug are provided on the site.

The T-10 HGH formula is described on your web site as, “ Sublingual T-10 HGH is sprayed directly into the mouth three times a day and is absorbed directly into the mucus membrane.” and as, “T-10 HGH - Real Recombinant Growth Hormone - 30 ml (1 fl. oz) - one month supply per bottle. . . . 600 nanograms per milliliter!”

The intended anti-aging treatment and disease treatment claims for T-10 HGH are conveyed on your Internet site. These include statements such as, “• HGH restores muscle mass• HGH decreases body fat • HGH increases sexual function• HGH thickens the skin, reducing wrinkles • HGH restores lost hair . . . • HGH improves cholesterol profile • HGH Improves vision• HGH improves memory • HGH elevates mood and improves sleep • HGH normalizes blood pressure • HGH increases cardiac output and stamina. . . .” The web site has a graph that reflects the benefits of using HGH to obtain positive effects on cholesterol levels.

T-10 HGH cannot be a dietary supplement because it is not intended for ingestion since it is absorbed directly through the cells of the oral mucosa, thus avoiding inactivation and destruction by the digestive system. The Federal Food, Drug and Cosmetic Act defines the term, “dietary supplement” in 21 U.S.C. 321(ff)(2)(A)(i) to mean a product that is “ . . . intended for ingestion . . . ” Consequently, a product that is not intended for ingestion cannot meet the definition of a dietary supplement.

The Food and Drug Administration (FDA) approved growth hormone as a new drug in 1940. Growth hormone was not marketed as a dietary supplement, nor as a food, before its approval as a drug. Therefore, growth hormone is excluded from the definition of a dietary supplement under 21 U.S.C. 321 (ff)(3)(6) because growth hormone is an article approved as a new drug under 21 U.S.C. 355.

Based on the claims cited above, T-10 HGH is a “drug” as defined by 21 U.S.C. 321(g). Moreover, the T-10 HGH is a “new drug” as defined by 21 U.S.C. 321(p) because there is no evidence that it is generally recognized as safe and effective for these intended uses. Under 21 U.S.C. 355(a), a “new drug” may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved new drug application (NDA) is in effect for such drug. The continued distribution of this product without an approved NDA violates 21 U.S.C. 355.

In addition, your T-10 HGH is misbranded under 21 U.S.C. 352(f)(1) because its labeling fails to bear adequate directions for the uses for which it is being offered and it is not exempt from this requirement under 21 CFR section 201.115 since it is an unapproved new drug.

Distribution of your T-10 HGH product also violates 21 U.S.C. 333(e)(1). Your growth hormone is being promoted and distributed on your web site for an unapproved use. There are no recombinant human growth hormone (somatotropin) products that are approved by the FDA for anti-aging treatment. 21 U.S.C. 333(e)(1) states that, “ . . .whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under 21 U.S.C. 355 and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by Title 18, United States Code, or both.”

This letter is not intended to be an all-inclusive review of your Internet sites, and the products your firm may market. The violations of the Act described above are not intended to be an all-inclusive list of the deficiencies of you and your firm. It is your responsibility to ensure that all drug products manufactured and distributed by your firm are in compliance with Federal laws and regulations.

Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.

You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Possible actions include seizure, injunction, and/or prosecution.

We request that you reply in writing within fifteen (15) days of your receipt of this letter stating the action your firm will take to discontinue marketing this drug product. Your response should be directed to Reynaldo R. Rodriguez, Jr, Director, Compliance Branch, at the U.S. Food and Drug Administration, Dallas District, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204.

Sincerely,

/s/

Michael A. Chappell
District Director
Dallas District Office