When it comes to buying herbals and supplements, here's the real deal as the law reads now:
- FDA does not approve dietary supplements or herbals. This means that any product falling into the dietary supplement category is not reviewed or approved for effectiveness and safety prior to being sold to you. FDA can evaluate safety and adverse events after these products are on the market and health concerns are brought to their attention. Basically a company does not have to prove up front that evidence-based research exits which finds that their supplement or herbal works. It's up to the FDA to police these products after an adverse event occurs and to prove there is a problem with safety or effectiveness.
- You know those claims on a supplement that describe the effect of the product on the human body such as ‘boost the immune system'? FDA does not approve these structure-function claims. There is a disclaimer on these products if you look closely for it stating that the claim has not been reviewed by FDA and that the product is not intended to diagnose, treat, cure or prevent disease.
- FDA does not approve companies so this means FDA does not approve product manufacturers. They can register with the FDA but this is not approval.
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