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  • FDA Announcement: Regulatory Oversight
FDA Announcement: Regulatory Oversight

There has long been a misconception that dietary supplements are “not regulated.” The fact of the matter is that dietary supplement producers are required to assure products are safe and to manufacture them according to a strict set of cGMPs (current Good Manufacturing Practices), and their label claims on the body must be substantiated and meet strict limitations.

“These statements have not been evaluated by the Food and Drug Administration…” does not mean the FDA neglects the industry. The Administration remains alert and active, according to Eric F. Greenberg of Healthcare Packaging.

The FDA is looking to amend its review of dietary supplements. The agency’s policy improvements include “communicating to the public as soon as possible when there is a concern about a dietary supplement on the market, ensuring that our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, continuing to work closely with our industry partners, developing new enforcement strategies and continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders,” says FDA commissioner Scott Gottlieb.

The FDA acknowledges that while supplements provide vital health effects for consumers, there are potential dangers “because they are adulterated or misbranded, for example by being “spiked with drug ingredients not declared on their labels,” in addition to featuring misleading claims.

The agency’s goal is to also improve its evaluation of New Dietary Ingredients, in other words, supplements that undergo some premarket FDA review. The FDA now claims they will collect public input on whether Congress needs to change the law itself, to, “for example, require a public list of all marketed dietary supplements, or provide market exclusivity for some products.”

As an exceptional service provider for the supplement industry, Makers Nutrition remains up to date and on the ball with all requirements necessary to ensure safety and success. The FDA’s consideration of its review process is in the best interest of both sellers and buyers of supplements, and the plans above project only better communication on all fronts.

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