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U.S. Department of Health and Human Services

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Enforcement Actions

TheraLife, Inc 01-Jun-07

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

Public Health Service
Food and Drug Administration

 

College Park, Maryland 20740


WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Lily Yang
TheraLife, Inc.
101 First Street, Suite 343
Los Altos, California 94022

Dear Ms Yang:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.theralife.com and has determined that the products "Wrist," "Fatigue," "Neck," and "Back & Leg" 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 web site 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:

"Don't let your Pain . . . run your life. Manage your pain NOW with TheraLife Products."

Wrist

"Treats pain in joint and cartiledge [sic], carpal tunnel syndrome, repetitive stress injury."

"Treats painful and chronic conditions often experienced by computer keyboard and mouse users. "

"The FDA registered solution for carpal tunnel syndrome, tennis elbow and other repetitive motion injuries."

Your web site also lists "uses" for ingredients in "Wrist" :

Cinnamomum
"This herb is used to . . . prevent infection . . . ."

Corydalis Yanhusuo
"This Chinese herb relieves pain mainly by improving circulation ."

Dangqui [sic]
"One of the most widely used herbs to treat . . . pain."

Ledbouriella [sic]
"This root is used to treat common colds with headache, body ache and stiff neck, and some joint pain."

Zinc
"A mineral that is important in healing wounds."

Fatigue

"[R]educes insomnia."

"Treats . . . mild insomnia."

Your web site also lists "uses" for ingredients in "Fatigue":

Ascorbic Acid
"An antioxidant that inhibits the formation of nitrosamines (a suspected carcinogen). "

Ginkgo biloba
"[T]reats vertigo and ringing in the ears."

Zinc
"A mineral which is important in healing wounds."

Neck

"Treats pain and soreness in the neck and shoulder areas due to overuse or injuries. This formula is made with select herbal extracts, vitamins and minerals to decrease local inflammation . . . . "

"The FDA registered treatment for neck and shoulder soreness and pain caused by overuse."

Your web site also lists "uses" for ingredients in "Neck":

Clematis Chinesis [sic]
"This herb is known for its sedative, pain-relieving, and antibacterial qualities."

Licorice Root
"One of the most widely used medicines in the world, it soothes inflamed mucous membranes, treats ulcers . . ."

Pueraria Root
"This herb is used to treat fever, colds, [and] migranes [sic] . . . ."

White Paeonia Root
"This root is known to relieve pain, reduce fever, protect against ulcers, and reduce inflammation. "

White Willow Bark
"It is used for muscle strains, headaches, inflammation and swollen joints."

Back & Leg

"Treats muscle pain in the lower back and leg."

"Relieves pain in the lower body resulting from periods of being in a stationary position, improper lifting, athletic activity or acute injuries. This high potency formula includes herbal extracts shown to decrease local inflammation . . . . "

"The FDA registered treatment for lower body pain resulting from periods of being in a stationary position, improper lifting, athletic activity or injuries."

Your web site also lists "uses" for ingredients in "Back & Leg":

Achyranthes
"This herb is known to have pain killing properties, specifically in the lower half of the body, treating aching back and knees."

Clematis Chinesis [sic]
"This herb is known for its sedative, pain-relieving, and antibacterial qualities."

Eucommia
"Commonly used for problems in the lower body, especially aching back and knees."

Furthermore, your products are not generally recognized as safe and effective for the above referenced conditions 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.

In addition, we note that you have placed the FDA logo on your home page with a hyperlink to the FDA website dockets page for the 30-Day Structure Function Claim Notification Letters for Dietary Supplements (where the FDA has published the letters you submitted under the requirement of 21 C.F.R. § 101.93(a)). You have also placed the logo above the statement, "Our products adhere to . . . all U.S. Food and Drug Administration (FDA) regulatory guidelines and requirements." We have cited several examples in this letter to demonstrate that you are not in compliance with the Act, which FDA enforces. The use of FDA's logo in your labeling is misleading in that it implies FDA approval or sanction of your products and their purported uses. Your products are thus misbranded under 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that their labeling is misleading.

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.

The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.

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. 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 Kristen L. Moe, Compliance Officer, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of Enforcement (HFS-608), 5100 Paint Branch Parkway, College Park, Maryland 20740-3835.

Sincerely,

/s/

Joseph R. Baca
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition