Earlier this month and exactly two months after FDA officials rebuked proposed legislation from the Personal Care Products Council (PCPC) and Independent Cosmetics Manufactures and Distributors Association (ICMAD) and ceased to continue any further negotiations with the industry groups, the agency met with executives from Procter & Gamble and Johnson & Johnson. After nine months of discussions, in July of 2013 all parties walked away believing that an agreement was reached on a detailed framework of principals for a credible, modern cosmetics system. In this edition of Briefing Notes let’s review where we stand on creating a bill that would overall the outdated Cosmetics Act of the 1938; yes you read that right 1938.
Legislative Review (Full Bill)
There have been several bills introduced over the past 5 years to update the current law, in March of 2013 Representatives Jan Schakowsky (D-IL) and Edward Markey (D-MA) introduced H.R. 1385, the Safe Cosmetics and Personal Care Products Act of 2013 to “amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of cosmetics by the Secretary of Health and Human Services (HHS).” The bill as written would:
- Require brand owners engaged in bringing a cosmetic to market for use in the United States to register annually and pay a fee for oversight and enforcement
- Require the Secretary to: (1) establish labeling requirements, (2) establish a safety standard that provides a reasonable certainty of no harm from exposure to a cosmetic or an ingredient in a cosmetic and that protects the public from any known or anticipated adverse health effects associated with the cosmetic or ingredient, and (3) issue guidance prescribing good manufacturing practices for cosmetics and ingredients
- Require brand owners to submit to the Secretary safety data for the ingredients listed on the cosmetic label and the cosmetic itself, which shall be published in a database
- Require the Secretary to review and evaluate the safety of cosmetics and ingredients of cosmetics that are marketed in interstate commerce, including nanotechnology and contaminants of concern linked to severe acute reactions or long-term adverse health effects.
- Require the Secretary, based on an initial review and evaluation, to establish three lists for ingredients: (1) a prohibited and restricted list, (2) a safe without limits list, and (3) a priority assessment list
- Authorize the Secretary to order a recall or cease of distribution for a cosmetic that is adulterated, misbranded, or otherwise in violation of the FFDCA
- Require reporting of any serious adverse event associated with cosmetics
- Require the Secretary to take action to minimize the use of animal testing of ingredients and cosmetics
- Establish an Interagency Council on Cosmetic Safety
- Require the Secretary of Labor to promulgate an occupational safety and health standard relating to cosmetics for professional use
PCPC Position (Full Report)
PCPC issued an official statement in April of 2013, in response to H.R. 1385’s introduction and on March 7th PCPC President & CEO released the following on their perspective: “We are extremely disappointed that FDA has indicated they will not participate in further discussions with the cosmetics industry regarding cosmetic legislation and have taken such a hard line approach to our efforts to operate in good faith…Regardless of whether the FDA chooses to return to the table, the personal care products industry will continue to work diligently to ensure that the families who trust and use our products continue to have the choices they want, the products they trust, and the confidence in their safety. We will work with Congress to pursue meaningful solutions.” Its clear PCPC want to move forward with their legislative push and proposal the following :
- Registering with FDA all facilities where those products are manufactured
- Reporting to FDA any serious unexpected adverse event with a personal care product experienced by consumers
- New Process to Set Safety Levels for Trace Constituents. When requested by a consumer or other stakeholder, or on its own initiative, FDA would be required to establish safe levels for trace constituents in cosmetic ingredients and products.
- New FDA Ingredient Review Process; once a request has been made or the FDA unilaterally determines action is warranted, the agency would be required to review the safety of any ingredient intended for use in a personal care product and set safety use levels for such ingredient on a specified timetable
- New FDA Oversight of CIR Findings; FDA would be required to review current and future findings on the safety of cosmetic ingredients by the Cosmetic Ingredient Review (CIR) Expert Panel and determine if FDA agrees with these findings. If there are instances in which it does not agree with a CIR ingredient review, FDA would determine by guidance or regulations if, or under what conditions, the ingredient can be used safely in personal care products
- FDA-Issued Good Manufacturing Practices; FDA would establish industry-wide “Good Manufacturing Practices” requirements
FDA Position (Full Report)
In the words of Michael R. Taylor, Deputy Commissioner for Foods and Veterinary Medicine, “I’m writing to express my profound disappointment in your proposed draft legislation on FDA oversight of cosmetic safety. As you know, FDA and your organizations worked diligently for over a year to reach agreement on a modernized regulatory framework.” So, here’s what the FDA had to say on how the industry draft legislation would undercut the safety of American cosmetics, it would:
- Force Congress declare a wide range of potentially harmful chemicals “safe” for use in cosmetics without a credible scientific basis, shifting the burden to FDA to prove them unsafe through a lengthy rulemaking;
- Require FDA to affirmatively find other cosmetic ingredients “safe” even if we knew that they posed real and substantial risks to consumers
- Require FDA to undergo a lengthy, unnecessarily burdensome process before declaring an ingredient unsafe, delaying actions to protect consumers by removing unsafe chemicals from cosmetics
- Virtually eliminate FDA’s ability to verify that cosmetic companies have substantiated the safety of their products
- Undercut FDA’s ability to enforce quality control rules for the safe manufacturing of cosmetics
- Prevent FDA from receiving reports of most illnesses and injuries from improperly manufactured or otherwise dangerous cosmetics, as well adding a provision that would severely undermine FDA’s ability to use the reporting system for its fundamental purpose: to detect signals of harm from cosmetics
- Fail to give FDA the authority to require cosmetic companies to register annually with FDA, reducing the agency’s ability to know who is making cosmetic products for sale to our citizens and what those products are
- Severely restrict FDA’s authority to keep unsafe cosmetics off the market; the industry draft would entirely eliminate States’ ability to oversee any aspect of the safety of cosmetics
It is clear that the FDA and the industry want the same outcome where we have a regulator that is not overburdened with conducting an overwhelming number of product reviews to ensure ingredient safety and where the FDA has the ability to “detect” when a product poses a risk to the public and respond with a swift hand. Unfortunately, PCPC’s draft is unlikely to garner the congressional co-sponsors and support it needs to pass congress. Why? PCPC’s draft bill is rooted is what is most favorable to the industry alone. Despite member fly-ins hosted this year by both PCPC and ICMAD, PCPC needs to work on forming a transparent coalition to craft legislation that protects consumers, provides the industry some certainty, but most importantly is actually a legislative vehicle for change. Likewise, the FDA may need to lick their wounds and come back to the table to reach an agreement on a legislative plan keeping in mind that what’s most important is to have a law protecting American consumers rather than ego.