By Jack Campitelli, JD: Just to set the record straight from the start, this report is not about how to ‘get around’ the United States Food and Drug Administration (FDA). The FDA is way too powerful for anyone to even think about such a thing. Anyone dealing in an area that the FDA claims interest in had better learn to play by the rules or expect to get crushed. There is no middle ground.
A lot of pioneers have done battle with the FDA, some of them survived, and the rules of engagement are pretty well settled. The FDA has an historic habit of expanding its watchdog role, while the proponents of the rights of individuals to make informed and determinative decisions about their own healthcare are fighting a ceaseless battle to keep the FDA’s wings trimmed.
As you’ll gather from this report, I’m not a fan of the FDA. I see it as a political creature. Perhaps trying to do good, but certainly involved in a tug of war between factions such as their perception of the public need versus the actual need of the public versus the demands of the AMA versus pharmaceutical giants versus the healthcare system versus insurance companies versus hospitals versus public health departments versus other healthcare providers versus alternative healthcare providers versus alternative healthcare products and drugs and supplements. I’ve got to tell you, this is a power group of folks who are currying the attention and blessing of the FDA. The stakes are very high.
As far as I am concerned, selling a nutritional product, a health-related product, including diet plans, is a much-watched area. Imagine a yellow caution light as soon as you enter this territory. I am aware that this is a multi-billion dollar market and a lot of folks, perhaps including you, want a piece of it. This report will help educate you about the ‘lay of the land’ but it is not a substitute for advice from a lawyer with experience in this area. The more novel your product or claim and the closer you are to ground zero, the more I would urge you consult with a professional.
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