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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Renewal Research 25-Sep-08

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

Public Health Service
Food and Drug Administration

 

San Francisco District
1431 Harbor Bay Parkway
Alameda. CA 94502-7070
Telephone: 510/337-6700


 

WARNING LETTER

VIA FEDERAL EXPRESS

September 25, 2008

Renewal Research
321 South Main Street #41
Sebastopol, CA 95472

Dear Sir or Madame:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.renewalresearch.com and has determined the products "DHEA (10mg, 25mg, 50mg)," "Folixor Folic Acid 5mg," "Green Tea Extract," "Lycopene" and "Vitamin D3 5000" are promoted for conditions that cause the 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 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:

DHEA (10mg, 25mg 50mg)

• "Decreases the risk of heart disease"
• "Defends against some cancers "
•"Improves blood sugar control, decreasing the risk of diabetes"
• "Prevents and reverses osteoporosis"

Folixor Folic Acid (5mg)

• "Prevention of several common cancers including breast, colon, and pancreas"
• "Reduction of homocysteine and prevention of atherosclerotic cardiovascular disease"
• "Reduced risk of heart attack and stroke"
• "[A] deficiency of folate may result in damage to DNA that may lead to cancer."
• "Several studies have associated diets low in folate with increased risk of breast, pancreatic, and colon cancer."
• "[L]ong-term folic acid supplementation (for 15 years) was associated with a decreased risk of colon cancer in women aged 55 to 69 years of age."
• "[F]olic acid supplements should be recommended to reduce the risk of cancer."

Green Tea Extract

• "Green tea has been extensively researched in recent years and has been shown to exert a broad variety of effects, including protection from osteoporosis, cancer. . . adult onset diabetes, and elevated cholesterol, and hypertension."
• "Research studies have shown geen (sic) tea extract to provide protection against several forms of cancer: skin, stomach, esophagus, liver, pancreas, duodenum, breast and colon."
• "Recent studies have shown a remarkable effect of green tea it helps protect the skin from proliferative damage (i.e., skin cancer). . .."
• "A component of green tea know as EGCG (epigallocatechin gallate) causes skin cancer cells to self destruct while leaving healthy skin cells unchanged."

Lycopene

• "Lycopene has also been positively associated with reduced risk of prostate, breast, and lung cancers, and might be protective of gastrointestinal and cervical cancers as well."
• "The following scientific findings make lycopene the single most important molecular candidate for prevention of prostate cancer: "

o Inhibits chemically induced tumors in rats.
o Inhibits spontaneous mammary tumor development in mice.
o Inhibits promotion stage of chemically induced tumor development in mice.
o Possesses anti-proliferative properties against mammary, endometrial, lung and transformed liver human cancer cells."

Vitamin D3 5000

• "Vitamin D has been shown to significantly reduce the risk of prostate cancer."
• "Recent research indicates that high normal levels of vitamin D provide protection from cancers of the breast. colon, ovary, as well as the prostate."
• "Recent research (sic) evidence suggests that vitamin D may not only prevent cancer, but also causes tumor regression."

Your products are not generally recognized as safe and effective for the above referenced conditions 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 "DHEA (10mg, 25mg, 50mg)," "Folixor Folic Acid 5mg," "Green Tea Extract," "Lycopene" and "Vitamin D3 5000" are also misbranded within the meaning of section 502(f)(1) of the Act in that 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 promoted 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 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.

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 Sergio Chavez, Compliance Officer, United States Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502.

Sincerely,

/S/

 

Barbara Cassens
Director
San Francisco District

Cc: Timothy J. Smith, MD
Renewal Research
5281 Thomas Road
Sebastopol, CA 95472