Should The Efficacy Of Natural Health Products Be Regulated?
This is an exclusive bombshell interview between Shawn Buckley and Del Bigtree.
Del Bigtree shares for the first time, a private conversation within Robert Kennedy Jr.’s leadership team at the department of Health and Human Services.
To market a drug in the United States, and in Canada, a company has to provide evidence of both the safety and efficacy of its products.
Under Health Canada’s incoming regulatory changes, natural health product companies will have to provide the same level of evidence that is expected of pharmaceutical drugs. Proving just the efficacy of a natural health product under a randomized controlled trial can cost hundreds of millions of dollars and makes it impossible for natural health product companies to comply with the chemical drug rules. The pharmaceutical framework also fails to consider the varying ways a singular natural health product can affect the body, and are uniquely efficacious for individuals.
When the U.S. began regulating drugs, the FDA only assessed safety and purity, they didn’t play a role in determining the efficacy of products. The discussion within the Kennedy inner-circle is whether to go back to a focus on safety and purity only. If efficacy no longer had to be proven (1) the government would stop being the marketing arm for chemical drugs, (2) it would level the playing field for natural products to exist, and (3) regulatory agencies will do a better job at determining the safety and purity of products.
These are just preliminary discussions within the Kennedy leadership team, and we should be having similar discussions here in Canada. Our focus should always be on getting the best health outcomes, unfortunately, that can not be achieved if the government continues to over-regulate access to natural health products.
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