Is It a Cosmetic, a Drug, or Both

Is It a Cosmetic, a Drug, or Both? - Webinar CD/Transcript

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Is It a Cosmetic, a Drug, or Both?: 15-Year Regulatory Veteran Shares Compliance Secrets

Ponder this: By adding just one new ingredient — or switching a supplier of an existing ingredient — you could be in violation of the law.

And that’s just the tip of the iceberg. There’s also product registration confusion, import holds, marketing claims and adverse events to worry about.

If you’re a cosmetic manufacturer, reseller, packager or labeler, the stakes are getting higher.

To learn how cosmetics regs may affect you, please read on ...

If you’re a cosmetics manufacturer, it’s tricky to know when your product is and is not regulated by the FDA.

Many cosmetics are actually regulated as OTC products and must be designed, approved, manufactured, labeled and marketed as such.

Whether the FDA views you as a cosmetics firm — or a quasi-drugmaker — it matters. FDA has been stepping up their inspectional scrutiny, and it shows in detailed warning letters.

And the FDA is not the only regulator to fret about. The Federal Trade Commission and the European Union (for global products) exercise oversight of U.S.-made cosmetics, too.

FDAnews invited top Washington cosmetics regulation lawyer and consultant Kim Egan to untangle the confusion. In 90 fast-paced minutes, she’ll bring you up to speed on how regulators approach your products and your processes, and help you avoid trouble. Here’s just a taste of what you’ll discover:

  • 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
  • And much more
  • Corporate officers
  • Product development
  • Manufacturing officers
  • Compliance officers
  • General/corporate counsel
  • Internal Auditors
  • Plant Managers
  • Regulatory/legislative affairs professionals

Kim Egan, principal of Saltbox Consulting, has 15 years’ experience practicing regulatory law and litigation in some of the country’s top firms. She began her career at Covington & Burling in Washington, and later chaired the Health Care and FDA Practice at DLA Piper in Washington. She started Saltbox Consulting to provide high-level compliance and regulatory advice to firms of all sizes. She appears on the Legal 500 list of Recommended Health Care and Life Sciences Lawyers, and has been listed in the International Who’s Who of Life Sciences Lawyers and the International Who’s Who of Business Lawyers since 2009.