June 11, 2020: Vol. 2 No. 8
Hand Sanitizer Webinar Recordings

ICMAD has been hosting a series of webinar events on the business challenges arising from COVID-19 pandemic.

We recently provided 2 sessions on Legal, Regulatory and Testing considerations for producing Hand Sanitizers. The recordings of these, and all past Online Events, are available on the COVID-19 page of the ICMAD website .

Join us TODAY for the next webinar: ICMAD COVID-19 Webinar: Selling Cosmetics to New Developing Overseas Markets - June 11, 3 PM ET
ICMAD Concierge Service

Have a question about one of these updates, or another technical/regulatory question?

Our Concierge Service is available to everyone in your organization as part of your membership. The ICMAD Team is ready and willing to provide answers, resources and guidance to any industry related question.

Contact us: concierge@icmad.org
FDA Webinar Recording Now Available: Monograph Reform Is Here! Learn What to Expect and How to Prepare

Dr. Theresa Michele, MD, Director of Nonprescription Drugs, CDER, presented a webinar on May 29 addressing some common questions regarding OTC Drug Reform resulting from the passage of the March CARES Act. This webinar contains valuable information for those looking to better understand the current and future regulation status for OTC Drugs. Highly recommended for those in, or interested in getting into, the hand sanitizer, sunscreen, skin protectant, acne, antiperspirant or anti-dandruff business.

  • Current system regulating Over-the-Counter Drugs and why there is a need for reform of the monograph system

  • Key elements of the new Monograph Reform legislation

  • How FDA will transition all monographs & how stakeholders might consider preparing for Monograph Reform

SURVEY - 2% Fragrance Exemption Elimination Proposed

CARB has requested industry to complete a survey about their proposal to remove the existing 2% Fragrance Exemption by 2031. This survey will help CARB understand how difficult removing this exemption might be, especially on small businesses. ICMAD will compile the survey results and submit them to CARB on behalf of the Membership.

If CARB eliminates the 2% fragrance exemption, there is a chance you may have to reformulate some or all of your VOC regulated products that contain fragrance. CARB is proposing new VOC limits on several categories, including hair finishing spray, dry shampoo and personal fragrance products. If you have any questions about the VOC proposals CARB is considering, please contact us.

The FTC & FDA are Cracking Down on Unsubstantiated Coronavirus Claims

The FTC and FDA continue to issue dozens upon dozens of joint Warning Letters to companies allegedly selling unapproved products that may violate federal law by making deceptive or scientifically unsupported claims about their ability to treat or cure coronavirus (COVID-19).

FDA's COVID-19 Naughty List Now Includes Marketers of Copper Germ Stoppers, '24-Hour' Hand Sanitizer
Partner Content: HBW Insight by Eileen Francis

Warning Letters issued by the FDA on May 28 target two companies using COVID-19 and other disease-prevention claims to market purported germ-killing products, including a rub touted as 24-hour protection and a line of copper rollers and other implements to disinfect hands and personal items.

CBD Recall - High Lead Levels

A CBD firm, Summitt Labs, is voluntarily recalling a batch of a tincture product after random sample testing by the Florida Department of Agriculture and Consumer Services found lead at 4.7 ppm in the product.  

FDA Warning Letter Leads to Voluntary Recall - Injectible CBD

Biota Biosciences is voluntarily recalling injectable CBD products because they are marketed without FDA approval and marketing claims make these product unapproved new drugs.

Class Action Risk From Using Color Additives Not Approved for the Eye Area In Eyeshadows/Pressed Pigments
 Partner Content: HBW Insight by Ryan Nelson

Huda Beauty Flouts U.S. Law With Neon Obsession, Ahem, 'Multiuse Pigments' - Class Action.

ICCR Updates
By Carl Geffken, ICMAD Board Member

ICMAD is honored to have a seat representing the U.S. entrepreneurial cosmetic industry as part of the U.S. delegation at ICCR. This article updates the ICMAD Membership on the ICCR international harmonization efforts underway among the regulators from U.S., Canada, EU, Japan, and Brazil.

United States - Mexico - Canada Agreement (USMCA): Effective July 1

If you plan or currently sell in Mexico and Canada, the replacement of NAFTA with USMCA will become effective on July 1, 2020. The U.S. Department of Commerce & International Trade Administration's new website contains key information about the agreement and how to prepare for Day One , including changes to the rules of origin and required certification.

India Regulatory Update

It is reported that the COVID-19 pandemic has delayed an anticipated 2020 announcement of new cosmetic legislation draft in India. When more information and timing is available about future draft legislation, we will make it available to our Members.
Would a Ban on PFAS Chemicals Impact Your Business?

Federal and State Legislators are looking at the PFAS category of chemicals for possible restrictions or bans in many categories - including cosmetics and personal care.

Per- and polyfluoroalkyl substances (PFAS) are a group of man-made chemicals that includes PFOA, PFOS, Teflon, GenX, and many other chemicals.

Please let us know whether future regulation of this chemical class would impact your business.

EU Turns up the Heat on PFAS with Broad REACH Registration Proposal in the Works
 Partner Content: HBW Insight by Ryan Nelson

FPer- and polyfluoroalkyl (PFAS) are under increasing scrutiny in the U.S. and Europe. Stakeholders have until July 31 to submit information to the authorities of five European countries as they prepare a joint proposal for a broad PFAS restriction under the bloc's REACH regulation.

What topics would you like to see covered? Would you like to submit an article to be published? Questions about tech/reg topics? Reach out!
Meredith Petillo, Director of Regulatory and Technical Services: mpetillo@icmad.org