On March 27, 2012, the Subcommittee on Health held a hearing—Examining the Current State of Cosmetics—gathering FDA, industry trade groups and more, debating the need for a national standard, preemption of state legislation and a modernization of FDA’s regulatory authority over the personal care and cosmetic industry.
From U.S. Rep. Leonard Lance (R-NJ) to the Personal Care Products Council (PCPC), many are in agreement for a need to create a national standard. “I believe a uniform standard for cosmetic ingredients would serve to enhance public health so long as it’s based on sound science and rigorous safety standards," Lance said.
Lezlee Westine, president and CEO, PCPC, agreed: “While cosmetic products remain among the safest in commerce, the existing system for regulating our industry is overdue for a makeover. The current process has served the public well for decades, but the time has come for us to advocate for additional safeguards as science and technology evolve."
During the opening statements, Congress proposed three questions:
- What deficiencies, if any, do you currently see in FDA’s regulatory authority over the cosmetic industry?
- What new authorities, if any, do you believe FDA needs in this area?
- And if new authorities are needed, what will be the impact on small businesses across the country?
Currently, cosmetic companies can register with FDA on a voluntary basis but FDA can’t compel them to register. FDA can enter and inspect cosmetic manufacturing facilities, but the industry doesn’t pay user fees for this purpose. Ranking Rep. Henry A. Waxman expanded this list, stating: “Cosmetics companies are not required to report cosmetic-related injuries to FDA or to let FDA know what ingredients are in their products. FDA doesn’t even have the ability to recall these products if they are found to be unsafe. To illustrate just how small FDA’s role in cosmetics oversight truly is, it is worth noting that FDA’s cosmetics program is staffed by just 53 people—only 14 of whom focus primarily on cosmetics—compared to the more than 3,000 staff that make up FDA’s drug review program."
Besides the use of color additives in cosmetics, FDA authorities are mainly post-market. Presently, no premarket notifications are required and the burden lies on companies, not on FDA to substantiate claims and test products for safety.
According to a June 2010 study conducted by PriceWaterhouseCoopers LLC (PwC), the personal care and cosmetics industry is responsible for 2.8 million jobs in the United States, made mainly up of small businesses, which creates a problem. State legislation makes it more than difficult for personal care and cosmetic companies to distribute their products across the country, as each state has the ability to create its own set of regulations and standards, clearly stifling the process of distribution and sale across state lines.
“What seems to be driving the train is that some states are beginning to adopt state regulatory issues that make it difficult for business themselves across state lines to operate in some of those states," said U.S. Rep Joe Barton (R-TX). In contrast to PCPC and others’ view, he argued working with each of the state legislatures is the best way to address this issue instead of creating a national standard, cautioning against more federal authority.
“State regulations would increase the cost with a disproportionate impact on small business owners," argued Curran Dandurand, co-founder and CEO of Jack Black LLC. “Science doesn’t change from state to state so individual state regulations make no sense."
The Small Business Dilemma and User Fee Controversy
The proposed bill at hand would require an annual registration for all companies—domestic and foreign—along with a user fee to help maintain that facility. It would also give FDA more authority and comprehensive oversight, including an annual listing of company products, serious adverse event reporting (AER), FDA recall authority and more. According to Michael M. Landa, J.D., director, Center for Food Safety and Applied Nutrition (CFSAN), FDA, user fees would help set safety standards and enable FDA to focus on ingredient safety and help establish good manufacturing practices (GMPs), add more investigators in the field, conduct training and education and outreach, and perhaps strengthen the voluntary system currently in place.
U.S. Rep. Jan Shikowsky (D-IL) urged for more, stating: “Cosmetics contain ingredients that can cause cancer, mutate cellular structure, and cause reproductive and development harm and the accumulative effects of exposure have to be considered. Any bill needs to include: the banning of carcinogens and reproductive toxins, full ingredient disclosure and labeling, and mandatory recall authority by FDA."
But Chairman Pitts challenged FDA’s budget request for $19 million in user fees. “Hasn’t FDA already received a significant increase in funds?" Landa said yes, but argued FDA only has a small amount of employees dedicated to cosmetics (53 total).
“Make no mistake," Barton cautioned. “If we give FDA authority they are going to use it. And if we give FDA user-free authority they will expand upon it. It’s almost a law of nature. If you give a federal authority more revenue they consume it and come back for more." It may seem cumbersome now, he noted, but down the line it will become more complicated.
Some even say—Deborah May, president and CEO of Wholesale Supplies Plus Inc.—$19 million wouldn’t be enough to execute all the agencies new proposed authorities, and we not in support of it.
With regards to small businesses and user fees, Landa said the details would have to be negotiated—the size of the fees could vary or possible exclusion and/or exemption. However, outside of the context of user fees, FDA has nothing to add about exemptions or exclusions with regards to small business; but others do.
May clearly outlined her support (or lack thereof) of the current bill, recognizing her support of giving FDA recall authority for cosmetics, requiring AER of serious reactions that cause loss of life and/or hospitalization, and the closing of labeling loopholes such as the current incidental ingredient exclusion that is used to hide such things as preservatives from the consumer. She also testified to her support of small business exemptions for facility registration allowing small and micro-businesses to make products for themselves, friends and family without the fear of breaking federal laws; and small business exemptions for fees. She made it clear she does not support a requirement to register with FDA individual product batches or requiring the producer to register each ingredient supplier used in that batch.
“Emerging small businesses grow by making and marketing products," she said. “If legislation is written in such a way that it strengthens the standing of safe ingredients then the volumes of paperwork for batch reporting serves only to give large corporations, that buy in truckloads and produce millions of units in a single batch, an even greater market advantage. Quite simply, in one month if a small business were to make 100 batches of 10 differently scented sugar scrubs using 10 different sugar suppliers, the reporting requirement would result in a minimum of 1,000 reports for just one product. If soaps and lotions are included, the business is easily looking at 5,000 reports in a 30-day period."
Cosmetic Ingredient Review
PCPC’s agenda is seeking to create formal processes for FDA to review ingredients for safety at the request of all public and stakeholder groups and to review all safety determinations made by the independent Cosmetic Ingredient Review (CIR) Expert Panel, which was established in 1976 with the support of FDA and the Consumer Federation of America.
Halyna Breslawec, Ph.D., chief scientist and executive vice president for science, PCPC, highlighted CIR’s role in the safety process of cosmetics, as it is the only scientific program in the world dedicated to a thorough and continuous review of cosmetic ingredient safety in a public forum. Its panel is an independent, non-profit body of physicians and scientists who examine and assess cosmetic ingredient safety data in an open, public manner. PCPC urged “FDA [to] incorporate the CIR into its product regulatory process," Breslawec said. “FDA should formally recognize the findings of the CIR Expert Panel as part of the regulatory regime for cosmetics."
Peter Barton Hutt, senior counsel, Covington and Burling LLP, also voiced his support for CIR, supporting the enactment of “Requiring FDA review of all Cosmetic Ingredient Review determinations on cosmetic ingredient safety and either acceptance or rejection of those determinations, followed by strong FDA enforcement.," which was one of seven principles Hutt named as a guide to the “Committee’s efforts to modernize FDA’s statutory authority over cosmetic products."
PCPC feels that while companies do assess the safety of products and ingredients prior to marketing, creating these new processes will provide the added transparency that consumers are seeking.
However, Ranking Member Frank Pallone (D-NJ), posed an issue with CIR, asking, “Would FDA be comfortable with having findings of CIR be binding on FDA?"
Landa testified, “As you know, they are not currently binding on the agency. Making them binding would raise a number of questions. As indicated earlier, the CIR is composed of individuals who are employees of the industry. So I think there’s always an issue of conflict of interest, bias, objectivity, that sort of thing. I think having private sector determinations be binding on FDA would be an unprecedented approach to regulation. Finally, there is probably a question to be asked if that type of delegation is even Constitutional?"
Other Issues
Latisse® was also brought up, as many cosmetic products currently on the market are using active pharmaceutical ingredients—such as the one used in Latisse—causing concern over FDA’s request for even more money and whether or not this will solve the problem, as the agency has yet to pull products with drug-grade ingredient s off the market, even after several requests have been made.
The number of chemical ingredients banned in the United States (10) by FDA compared to the number of chemical ingredients banned in the EU (more than 1,200) was another issue discussed in various contexts. As many know, California’s Prop 65 includes a list of chemicals known or suspected by the state to cause cancer or birth defects, and mandates companies to give notice of use of these chemicals. California’s banned list of almost 25,000 hazardous ingredients implies the U.S. ban list is lacking or somehow incomplete. However, Hutt and Breslawec argued more than half of the state’s list was titanium dioxide, which is used in sunscreens and an approved ingredient by FDA. And, when asked about the use of formaldehyde, as in the case of Brazilian Blowout (which was brought up several times during the hearing), PCPC said it can be used safely as a preservative in cosmetics at very low levels. Needless to say, this was a point of contention.
Although she did not testify at the hearing, Stacy Malkan, co-founder of Campaign for Safe Cosmetics, told Inside Cosmeceuticals: “PCPC is not doing the cosmetics industry any favors by trotting out former convicts to question the motives of health groups and lawyers to testify that toxic chemicals in baby shampoo are safe. The trade association's PR and lobbying efforts are making the industry look really bad.
“We are watching this process very closely to make sure any new rules protect public health and don't set the industry back another 70 years. We would love to see the big beauty companies spending their money innovating the next generation of safer products—products without formaldehyde, 1,4 dioxane, parabens, triclosan, lead, etc.—instead of lobbying to get rid of important efforts like the state of California's safe cosmetics program."
