FDA Updated Its Earlier Guidance for Hand Sanitizer Production

On April 15, 2020, the FDA updated and issued as”final” the three guidance documents it had prepared to promote the availability of hand sanitizers during the COVID-19 crisis, found at: (1) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-temporary-compounding-certain-alcohol-based-hand-sanitizer-products-during-public-health; (2) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-policy-preparation-certain-alcohol-based-hand-sanitizer-products-during; and (3) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-manufacture-alcohol-incorporation-alcohol-based-hand-sanitizer-products-during. None of the three updates to the guidances retract the FDA’s initial advisory announcements that for the duration of the [...]

FDA ISSUES ADDITIONAL GUIDANCE TO PROMOTE AVAILABILITY OF HAND SANITIZERS DURING COVID-19 EMERGENCY

As noted in our prior post, in response to the demand for hand sanitizers created by the COVID 19 crisis, the FDA announced it would not pursue actions during the pendency of the crisis against state-licensed pharmacies or Federal facilities or registered outsourcing facilities for the compounding of alcohol-based hand sanitizers, provided the resulting products [...]

Hand Sanitizers, COVID19 and FDA Regulatory Actions – Recent Developments

Wow! What a different world we are in than just a month ago.  As consumers lives have been shifted by the sudden emergence of the threat of the COVID-19 virus, the FDA has acted quickly to show that it is not asleep at the wheel, and that it will act both to increase the availability [...]

FDA RAISES WARNING FLAGS FOR MARKETING OF CBD PRODUCTS

Happy New Year! 2019 was quite the year in many regards. One such area was the significant growth of the CBD marketplace. In response, in the last quarter of the year, the Food & Drug Administration (“FDA”) got busy issuing warning letters and posting consumer notices regarding the safety and use of cannabidiol ("CBD"). For [...]

GRMA is Now an Independent Nonprofit Organization

GRMA is Now an Independent Nonprofit Organization

As I previously announced, I Chair the GRMA Joint Committee on the Good Manufacturing Practices for Cosmetics. I am excited to share after 4-years of hard work by so many of its members, the Global Retailer and Manufacturers Alliance ("GRMA") is now an official, independent nonprofit organization! Many major retailers, manufacturers, trade associations and certification bodies [...]

Unintentional Drug Claims on Cosmetics Not Actionable

Unintentional Drug Claims on Cosmetics Not Actionable

Last month, a long running case against Beiersdorf, Inc., makers of Nivea, was dismissed.  I would normally prepare a summary myself, but in this case, the first 3 paragraphs of the court's opinion provides a great summary: Five years ago, Ashley Franz purchased a $10 bottle of Nivea's Skin Firming Hydration Body Lotion from a [...]

Busy “Warning Letters” Month for Cosmetics

Busy “Warning Letters” Month for Cosmetics

In July, the U.S. FDA issued four warning letters to cosmetics companies.  Although only two were prepared by the same office, there were consistent themes across the four letters.  As previously discussed here, the FDA continues to crack down on companies making what amount to drug claims on various "cosmetic" products.  But what companies need [...]

FDA Seeks Public Input on the Term “Natural” for Food Products

The U.S. Food and Drug Administration ("FDA") announced the establishment of a docket to receive information and comments from the public on the use of the term "natural" in food labeling.  The FDA's action is in response to 3 citizen petitions asking that the FDA define the term "natural" and 1 citizen petition asking the [...]

“Personal Care Products Safety Act” S. 1014: Proposed Legislation that will Have a Huge Impact on the Cosmetics Industry if Enacted

On April 20, 2015, Senators Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) introduced the Personal Care Products Safety Act (S. 1014).  This post provides a summary of keys sections of the proposed bill with a comparison to existing law. According to the press release issued by Senator Feinstein's office, the S. 1014 has the support of [...]

More FDA Warning Letters: Strong Enforcement Continues in 2015

More FDA Warning Letters: Strong Enforcement Continues in 2015

Traveling to and attending various conferences has prevented me from posting for a couple weeks. So although I have not had time to blog, there has been much to write about-- including the latest round of FDA Warning Letters.  In February and March alone, the FDA has issued at least 5 Warning Letters challenging the drug claims [...]