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FDA LABELING

FDA LABELING. Richard D. Massey, JD, MBA, TAS Regulatory Affairs Manager SnugZ USA, Inc. Salt Lake City, UT. Disclaimer.

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FDA LABELING

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  1. FDA LABELING Richard D. Massey, JD, MBA, TAS Regulatory Affairs Manager SnugZ USA, Inc. Salt Lake City, UT

  2. Disclaimer This information is being furnished by PPAI for educational and informational purposes only. The Association makes no warranties or representations about specific dates, coverage or application. Consult with appropriate legal counsel about the specific application of the law to your business and products.

  3. Labeling Concerns For Promotional Products Business • Cosmetics • Over-the-counter (OTC) drugs • Consistency in Principle Display Panel (PDP) Requirements • Statement of Identity • Weight

  4. Facility Registrations • Do I have to register my facility with the FDA? • Only if you manufacture or store OTC drugs. • Complicated process that requires specially registered computer with FDA, with security certificates held by the FDA through FDA’s submission portal

  5. Is it a Drug or a Cosmetic? • Drug is defined as • Products intended to treat or prevent disease, or affect the structure or function of the body. • Examples • Sunscreen • Dandruff Shampoo • Acne treatment • Antiperspirants • Anything that makes a claim to treat or prevent

  6. Cosmetic • Cosmetic is defined as: articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing beautifying, promoting attractiveness, or altering the appearance.” • Doesn’t claim to treat or prevent anything

  7. Cosmetic Continued • Examples • Moisturizers • Perfumes • Lipstick • Fingernail polish • Cleansing shampoos • Hair colors

  8. How Do I tell the Difference? • Drugs make claims. Cosmetics do not. • “Balm” is a claim. Moisturizer is not.” • Can it be both a drug and a cosmetic? Yes • A sunscreen that is also a moisturizer is both a cosmetic and an OTC drug if the moisturizing claim is on the container. • Proper labeling is imperative for FDA compliance

  9. Cosmetic Label Sample

  10. OTC Drug Label Sample

  11. CAUTION Regardless of the size of the container, it must be labeled properly. If you have a lip moisturizer, in a lip balm tube, making an SPF claim-it must be label as an OTC. So, you have to put all of the information on the sunscreen bottle on the label of that lip balm tube.

  12. Questions?

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