Decades of research has affirmed that natural products are safe and effective, and in many cases, can be a desirable alternative to pharmaceutical drugs for promoting health, alleviating symptoms, and curing disease.
However, regulators such as the FDA have created a “Catch-22” that prevents dietary supplement manufacturers from informing consumers about potential health benefits and introducing innovative new ingredients. The Catch-22 also threatens many supplements that are already on the market.
If a dietary supplement manufacturer wants to make any statement the FDA deems to be a “disease claim” or introduce a new ingredient the FDA deems to be a “new dietary ingredient,” the manufacturer must withstand the extremely lengthy and expensive drug approval process that is only meant for traditional pharmaceuticals, not dietary supplements which are regulated as a category of food.
It is impossible for most dietary supplement manufacturers to withstand the financial burden of the drug approval process, which can cost millions or even billions of dollars, because natural ingredients that have been in use for decades cannot be patented. Without patent protection, dietary supplement manufactures are unable to recoup the cost of a drug-like preapproval process.
Forcing dietary supplements into a regulatory framework that was designed only for pharmaceuticals raises cost for consumers, decreases innovation and choice, and could force tens of thousands of safe supplements out of the market.
Defending dietary supplements from attacks by the media, the pharmaceutical industry, and elected officials who prefer a pre-market approval approach is a top priority.