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Public Health Service |
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Office of Compliance |
Department of Health and Human Services
October 12, 2006
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
FulLife Natural Options
4756 Boca Raton Blvd #3
Boca Raton, FL 33431
Dear Sir or Madam:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.charanteausa.com and has determined that the product Charantea is promoted for conditions that cause these products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)]. The therapeutic claims on your website establish that these 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 in the form of testimonials include:
- " It … reduces blood sugar levels, balances insulin level…"
- "Charantea helps me lower my blood sugar level naturally."
- "With Charantea fortifying my diet, my doctor is able to reduce my medication."
- "I am a diabetic for 15 years now … The combination of insulin and this tea allows me to gain better control of my diabetes."
Other claims found on your website:
- "In many cases … they were able to greatly reduce the more expensive diabetes medicines."
- "The addition of Charnatea food supplements helps sensitize the body to the diabetic medications."
- "It is also our experience that in mast cases, after a few days or within a month after our diabetic patients starts drinking Charantia tea to fortify their usual daily diet, regular exercise and medication, their blood sugar goes down to an even lower level than before, there is less sharp rises [sic] or 'spiking' and it remains more stable for longer periods of time."
- "What I've seen in my patients is that their blood sugar has decreased, plus they felt much better and those who have wounds, they healed faster (with regular use of Charantia)."
These claims are further supplemented by the metatags that you use to bring consumers to your website. These metatags include "Enjoy Lower Blood Sugar Naturally," and "Proven to improve glucose tolerance & lower blood sugar."
Furthermore, your product is not generally recognized as safe and effective for the above referenced conditions, and, therefore, the product is also a "new drug" under section 201(p) of the Act [21 USC 321(p)]. New drugs may not be legally marketed in the US without prior approval from FDA as described in section 505(a) of the Act [21 USC 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.
These products are also misbranded within the meaning of Section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use [21 USC 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 website, noticed that you promoted other products for disease treatment and/or prevention. 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.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
Please advise this office in writing, within 15 working days of receipt of this letter, as to the specific steps you have taken or will be taking to correct these violations, including the steps taken to assure that similar violations do not recur. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Your reply should be addressed to Kristen Moe, Compliance Officer, US Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of Compliance and Enforcement (HFS-607), 5100 Paint Branch Pkwy, College Park, MD 20740-3835. If you prefer to respond electronically, send your e-mail to kristen.moe@fda.hhs.gov If you have any questions concerning this letter, please contact Ms Moe at 301-436-2064.
Sincerely,
/s/
Joseph R. Baca
Office Director
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