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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Natural Biology, Inc. 09-Oct-08

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

Public Health Service
Food and Drug Administration

 

Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30309


October 9, 2008

VIA FEDERAL EXPRESS

James Bruner
Natural Biology, Inc.
105 Nobility Court
Roswell, Georgia 30075

WARNING LETTER
(09-ATL-01)

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.naturalbiology.com and has determined that the products "Nano HGH" and "Vintage Resveratrol" 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)(B)]. 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 website include:

Nano HGH

Under the heading "Description of Ingredients":

• "L Arginine - 5,000mg . . . Other Benefits: Positive claims for 1-arginine included . . . fighting cancer, promoting healing of burns and other wounds, . . . and restoring sexual function in impotent men."

• "Okinawa Marine Grade Coral Calcium - 900mg . . . Nothing helps the body realize a balanced pH than [sic] Okinawa Marine Grade Coral Calcium . . . . Some research from Nobel Prize Winners suggest [sic] an Alkaline body pH makes it impossible to contract cancer and other chronic diseases."

Vintage Resveratrol

• "Studies have shown that Resveratrol has several health benefits such as anti-cancer, antiviral . . . and anti-inflammatory. Resveratrol appears to decrease tumor promotion activity by inhibiting cyclooxygenase-1 (COX-1)."

• "Generai Benefit of Using Vintage Resveratrol 100%

• Type II diabetes, improved insulin signaling
• Neurodegenerative diseases, protection of the nervous system . . .
• Atherosclerosis, improved fat metabolism, decrease in inflammation
• Cancer, improved clearance of aberrant cells"

• "Specific Benefits of the Resveratrol Molecule

• Controls high blood pressure,
• Lowers Bad Cholesterol . . .
• Inhibits blood clots
• Prevents damage caused by lack of oxygen to brain and heart
• Reduces risk of breast cancer
• Causes aptosis (death of cancer cells)
• Lowers PSA levels in males; reduces the risk of prostate cancer"

In addition to the above claims on the order page for Vintage Resveratrol, webpages in the "Health News and Research" section of your website also promote the use of your product to treat or prevent cancer and other diseases, either by describing research concerning the use of resveratrol for such purposes or by simply listing the purported medical benefits of resveratrol. These webpages also contain a link to the order page for Vintage Resveratrol. Examples of disease claims for resveratrol in your website's "Health News and Research" section include:

• "Resveratrol Inhibits Growth of Myeloma Cells"

• "Works as an anti-depressant by inhibiting the enzyme monoamine oxidase (MAO inhibitor."

• "Eradicates brain plaque called beta amyloid, believed to be involved in Alzheimer's disease."

• "Prevents blood clots, bacteria, viruses, cancer cells and cholesterol plaque from sticking to the inside wall of arteries by an anti-adhesion factor, thus preventing the spread of cancer and infection."

• "According to Pezzuto, 'Of all the plants we've tested for cancer chemopreventive activity, this one [resveratrol] has the greatest promise' (Pezzuto 1997)."

• "Resveratrol was effective against cancer during all three phases of the cancer process: initiation, promotion, and progression. For example, resveratrol displayedantimutagenic and antioxidant activity, providing greater protection against DNA damage than vitamins C, E, or beta-carotene. Resveratrol restored glutathione levels, considered by some as the most essential of antioxidants (Jang et al. 1999)."

• "Resveratrol inhibited the activity of cyclooxygenase-2 (COX-2), reducing the inflammatory response in human epithelial cells (Subbaramaiah et al. 1999). Upregulation of COX-2 is associated with the physical manifestations of various human cancers, as well as other inflammatory disorders. Since inflammation is closely linked to tumor promotion, substances with potent anti-inflammatory activities are thought to exert chemopreventive effects, particularly in the promotion stage of the disease."

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 "Nano HGH" and "Vintage Resveratrol" 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 other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. 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 Philip S. Campbell, Compliance Officer, at the address noted in the letterhead. If you wish to discuss this letter, you should contact Mr. Campbell at (404) 253-1280.

Sincerely,

/S/

Mary Wolrsske
District Director

cc: Associate Director
Division of Advertising Practices
Federal Trade Commission
600 Pennsylvania Avenue, N.W.
Washington, D.C. 20580