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

Public Health Service
Food and Drug Administration
  Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30309

June 9, 2008

VIA FEDERAL EXPRESS

Cecilia Salvadori, President
New Sun, Inc.
215 Linda Vista Dr.
Hendersonville, NC 29792

WARNING LETTER
(08-ATL-11)

Dear Ms. Salvadori:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.newsun.net and has determined that the products "New Sun Grape Seed Extract," "New Sun Super Sam (TOA Free Cat's Claw)" and "New Sun Yew/Olive Combination," 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)]. 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:

New Sun Grape Seed Extract

New Sun Super Sam (TOA Free Cat's Claw)

New Sun Yew/Olive Combination

Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are also "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 "New Sun Grape Seed Extract," "New Sun Super Sam" and "New Sun Yew/Olive Combination" 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. The unlawful disease treatment and prevention claims on your website are 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 for causing violations of the Act [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 Woleske
District Director

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

This page was posted on July 19, 2010.

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