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How Supplements Are Made and Regulated

Are supplements regulated by the FDA?

The Food and Drug Administration (FDA) regulates dietary supplements, but in a different way than “conventional” food and drug products. The rules governing regulation were instituted by the Dietary Supplement Health and Education Act of 1994 (DSHEA), which states that manufacturers and distributors of dietary supplements are prohibited from marketing products that are adulterated or misbranded. FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.

NatureWise, like all other supplement companies, is responsible for evaluating the safety and labeling of our products before they go to market to ensure that they meet all the requirements of DSHEA and FDA regulations. This obligation is taken very seriously and NatureWise takes steps to foresee and head off any statements or labeling that could be misconstrued as an unsupported claim. All sales copy and labels are carefully reviewed by DavidPaul Doyle, the medical director Igor Schwartzman, and legal representation to proactively manage risk.

What is considered a health claim?

Health claims describe a relationship between a food substance (a food, food component, or dietary supplement ingredient), and reduced risk of a disease or health-related condition. An example of a claim would be “omega-3 fatty acids support heart health.” These claims need to be supported by scientific evidence.  In the absence of a declared credible scientific study, a company can sometimes petition FDA by presenting additional evidence.

How are supplements made at NatureWise?

All NatureWise supplements are doctor-formulated by our on-staff Medical Director. Potential products are extensively researched to determine the a) best ingredients b) optimal dosage for benefit c) potential health claims that can be substantiated by evidence. Once formulated, our products are manufactured according to GMP guidelines that provide a system of processes, procedures, and documentation to assure a product has the identity, strength, composition, quality, and purity that appear on its label.

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