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 [...]

Unapproved Drug Claims – The Continuing Saga for Cosmetic Brands

Unapproved "drug" claims - a continuing saga. In prior posts we have discussed the importance of cosmetic brands to avoid "drug" claims, and have discussed court rulings on the topic. Unfortunately, such marketing claims continue to be boasted by big and small brands alike, so it is no surprise we have seen an increase in [...]

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 [...]

Even More July Warning Letters…

Even More July Warning Letters…

Today the FDA posted an additional 5 warning letters issued at the end of July to cosmetics companies addressing drug claims. The letters were issued to:  MiN New York;  Lavian Ltd.; Peter Thomas Roth Labs, LLC; TPR Holdings LLC; and Finally Pure, LLC. The challenged claims were very similar to those claims addressed in the [...]

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 [...]