Date: 10/13/2007 7:16:32 AM ( 10y ago ) Hits:10263
We live in a governed society where there are rules and laws that we must follow.
So, if alternative practitioners can start claiming to heal people with their drugs, then I guess we could also believe that someone who wants to help others stay safe could put on an "alternative" police officer uniform and go around policing others???
Again, there are rules.
“product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease”
Definition of drug:
"a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (3): a substance other than food intended to affect the structure or function of the body"
·"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 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 product "Chararttea" is also misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for this drug fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
What the FDA tells company to do to resolve issue:
This letter is not intended to be an all-inclusive review of your web site and products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations . We urge you to review your web site, 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.
They simply need to get smart and learn how to work around the rules, it can be done.