|Company:||New Sun, Inc.|
|Subject:||Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated|
|Issuer:||Atlanta District Office|
|Issued:||June 9, 2008||Closed:||
Department of Health and Human Services
Public Health Service
Atlanta District Office
June 9, 2008
VIA FEDERAL EXPRESS
Cecilia Salvadori, President
New Sun, Inc.
215 Linda Vista Dr.
Hendersonville, NC 29792
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
• "[U]seful to help prevent diseased blood vessels associated with ... peripheral hemorrhage, diabetic retinopathy, high blood pressure ...."
• "[E]ffective anti-inflammatory ... which assists in relieving swollen joints, athletic injuries and pain."
• "Helps relieve phlebitis and risk of phlebitis ...."
• "Supportive in ... [r]eduction of diabetic neuropathy ...."
New Sun Super Sam (TOA Free Cat's Claw)
• "[E]ffective for a wide range of immune system related conditions, especially LYME Disease. These include but are not limited to: ALLERGIES ARTHRITIS BURSITIS CANCER ... CHRONIC FATIGUE SYNDROME DIABETES DEPRESSION HERPES HIV INFECTION INTESTINAL DISORDERS LUPUS ... PARASITES RHEUMATISM SYSTEMATIC CANDIDIASIS (YEAST OVERGROWTH) ULCERS ... [.]"
• "By supporting and enhancing immune system function, Samento [a botanical ingredient in your product] is indicated in a broad spectrum of conditions including all types of infections."
• "Urarina tribesmen of Peru tell stories of Samento curing tumors. Samento was one of the plants researched by the National Institute for Health as an anticancer agent."
• "Worldwide research done on this powerful herb has led scientists to patent many of the single chemicals found in it for use in healing cancer, arthritis, AIDS and other diseases."
• "Samento can be used for Crohn's disease ... parasites ... ulcers, gastritis, allergic disorders, diverticulitis ...."
• "An 8-month pilot study was recently conducted with 28 patients suffering from ADVANCE CHRONIC LYME BORRELIOSIS. ... The experimental group was treated with Samento .... At the end of the study 85% of the patients in this group tested negative for Lyme Disease and all the patients experienced a dramatic improvement in their clinical condition."
• [under the heading "As reported by Nutra News:"] "Research from 1970 through the present ... has shown beneficial effects of Samento in the treatments for cancer, genital herpes, systemic candidiasis and AIDS. ... My own preliminary studies on the immune-enhancing properties of Samento have uncovered the following: An ability to STOP VIRAL INFECTIONS in the early stages .... An ability to help the body fight infections better in AIDS patients. AN ABILITY TO DECREASE THE VISIBLE SIZE OF SOME SKIN, TUMOR OR CYST GAROWTHS [sic] WITHIN TWO WEEKS."
• "WHY TOA-FREE CAT'S CLAW SUCCESSFULLY TREATS OVER 100 DISEASES
... TOA-Free Cat's Claw outrivaled everything known in therapy .... It has healing range unseen so far. These claims and conclusions do not rely on existing publications ... but on my own practice as a healer. My files include thousands of patients: lung cancer cases exceed 100, and the Helicobacter pylori infections - 400, hypertension sufferers - 700, MS patients - 50, and dozens of patients with diabetes, lupus erythematosus, bronchial asthma, polycystic kidney disease, etc." [According to your website, this paragraph is taken in part from an April 2003 article written by Atanas Tzonkov in Lechitel Weekly, Sofia, Bulgaria.]
New Sun Yew/Olive Combination
• "Olive, as well as Yew, has shown to be a very effective antiviral and anti-bacterial herb ...."
• "Olive leaf ... was used for malaria infections with reports stating they worked better than Quinine. It seems to be effective against many strains of viruses and bacteria. Olive Leaf also seems to be effective on latent viruses as well."
• "A small amount of Achilla Millefolium (Yarrow) has been added to this combination
.... It has been used for colds, flu, chills, and fever."
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.
cc: Associate Director
Division of Advertising Practices
Federal Trade Commission
600 Pennsylvania Avenue, N.W.
Washington, D.C. 20580