What exactly are Nutraceuticals? This is a brief overview of how the Food & Drugs Administration (FDA) regulates Nutraceuticals. According to the industry, Nutraceuticals are ‘pharmaceutical grade’ nutrients that are consumed for a health benefit. In reality, they are vitamins, minerals, herbs, and extracts.
According to the FDA regulations, most Nutraceuticals would be categorized as “dietary supplements”. These are extracts, concentrates or combinations of vitamins, minerals, botanicals, herbs, or dietary substances “for use by man to supplement the diet by increasing the total dietary intake.” But you wont find the word “Nutraceutical” in federal law. The only place it appears on the FDA website is in the names of companies and distributors that have received warning letters for violating FDA regulations.
One of the primary indicators between dietary supplements and drugs relates to health claims. Whereas a dietary supplement is meant to provide nutrients and a drug is designed to treat illness or disease. So, in order to maintain classification as a dietary supplement and avoid the FDA’s strict drug approval process and regulations. Nutraceuticals must make it clear that they are not intended to treat, diagnose, prevent, or cure diseases. Therefore no label claims about treating pain, or preventing cancer.
So how are these Nutraceuticals being regulated? Producers or Nutraceuticals classified as dietary supplements are required to register their facility with the FDA. Much like foods, producers of Nutraceuticals are expected to comply with Current Good Manufacturing Practices. These guidelines outline facility standards, employee practices, and sanitation requirements to ensure that the product is produced in a safe manner.
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