New York District
158-15 Liberty Avenue
Jamaica, NY 11433
November 8, 2010
WARNING LETTER NYK-2011-08
VIA UPS
Cary Heather, CEO
266 Elmwood Avenue, Suite 357
Buffalo, New York 14222-2202
Dear Mr. Heather:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.zooscape.com in August 2010 and has determined that the products TerraVita Ginkgo Biloba Leaf Powder (4 oz), TerraVita Dog Grass Root 450 mg (100 softgels), and Webber Naturals Omega-3 Super Concentrate (80 softgels) are promoted for conditions that cause them 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 the products with these claims violates the Act.
Examples of some of the claims observed on your web site include, but are not limited to, the following:
TerraVita Ginkgo Biloba Leaf Powder (4 oz)
• "Has been used to treat Alzheimer's Disease, depression, impotence "
• "[I]t [ginkgo leaf extract] shows some activity against Pneumocystis carinii, arrests fibrosis ... "
TerraVita Dog Grass Root 450 mg 100 softgels)
• "Effectively treats jaundice, gout, eczema ... "
• "Dog Grass Root may be used effectively in urinary infections such as cystitis, urethritis and prostatitis."
• "Dog Grass Root may also be used in cases of kidney stones and gravel."
• "As a tonic diuretic, Dog Grass Root has been used ... in the treatment of rheumatism."
• "For urinary tract infections, this herb has been used effectively ...."
• "Juice from the root has been used to treat jaundice and liver ailments ...."
Webber Naturals Omega-3 Super Concentrate (80 softgels)
• "[I]t [omega-3] provides some ability to lower cholesterol ...."
• "It [EPA, an ingredient in your product] also helps lower the risk of heart attacks, strokes and pulmonary embolisms. DHA, the other active factor in Webber's Omega-3, also plays an important part in reducing the risk of depression."
The products that you distribute 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.
The above violations are not meant to be an inclusive list of deficiencies in the products that you distribute or their labeling. It is your responsibility to ensure that all of the products that you distribute are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory actions without further notice, such as seizure and/or injunction.
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 Kristen C. Jackson, Compliance Officer, U.S. Food and Drug Administration. If you have any questions regarding any issues in this letter, please contact her at 718-662-5711.
Sincerely,
/S/
Ronald M. Pace
District Director
No comments:
Post a Comment