Webinar focuses on how to stay within FDA regulations

By Simon Pitman

- Last updated on GMT

Webinar focuses on how to stay within FDA regulations

Related tags Over-the-counter drug

Regulation specialist FDAnews is hosting a webinar that aims to show cosmetic manufacturing experts how they can avoid the many potential pitfalls presented by  FDA regulations in the United States.

The webinar, which is being hosted by an industry veteran with a total of 15 years experience specific to regulation, will shine a light on areas such as reformulation, registration, import holds, marketing claims and adverse events.

The host will be regulation lawyer and industry consultant Kim Egan, who will take the webinar audience on a 90-minute presentation on how regulators approach product regulation, and how to avoid potential problems.

Aimed at formulation experts, marketers, resellers, packaging and labeling professionals, the aim of the webinar is to point out where potential problems may arise, before they happen, often causing significant business disruption.

According to the organizers, the complexity of FDA regulation often means that it is difficult to know when a product is or is not regulated by the government body.

Does the product claims make it fall within the OTC category?

This is because many cosmetics are regulated as OTC products, mainly ones that make physiological or medicinal claims, which means they have to be designed, approved and manufactured according to the specific regulations that govern this category.

Often knowing whether or not product claims put it within the realm of the OTC category is puzzling, evinced by a series of FDA warning letters that were sent out to some of the biggest cosmetics players, including Avon and L’Oreal, concerning claims about anti-aging products.

The program will include some of these topics:

  • How to determine whether a product will be regulated as a cosmetic or an OTC drug (or both)
  •  GMP and cosmetic manufacturing: New and troubling violations being unearthed by FDA investigators
  • How the FDA regulates medicinal-related advertising claims of cosmetics
  • How the FTC oversees ad claim falseness and/or exaggeration
  • Learning from others’ mistakes: Recent seizure activity in cosmetics manufacturing and how you can avoid it
  •  Review of recent cosmetics warning letters — emphasis on new or novel interpretation of the regulations as they have been applied to cosmetics

The webinar will take place on August 23rd​, at 1:30pm – 3pm EDT For registration details please follow this link http://www.fdanews.com/CosmeticsWebinarPR2

Related topics Regulation & Safety

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