Regulatory Focus™ > News Articles > Botanical Products: Drugs and Dietary Supplements

Botanical Products: Drugs and Dietary Supplements

Posted 01 August 2009

US regulations for botanical products that may be drugs can be confusing. In the author's experience, some botanicals that may have been processed and/or concentrated and have an indicated use for medical treatment are looked upon by the manufacturer as food supplements. Manufacturers take this position to avoid going through the rigors of the drug approval process. There are loopholes in the regulations that manufacturers try to use to eliminate this process.


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