WASHINGTON — An overhaul of the U.S. Food and Drug Administration’s oversight of cosmetics has been a long time in the making and efforts to reach a compromise on legislation appear to be slowly moving forward.
The FDA’s regulatory authority over cosmetics is contained in a two-page section of the Federal Food, Drug and Cosmetic Act of 1938, and all stakeholders involved, including the personal-care products industry, argue it needs to be expanded and updated.
Experts argue the FDA’s authority has not kept pace with the growth of the estimated $60 billion personal-care products industry that has launched thousands of products containing scores of new ingredients over the past several decades.
The need for reform has been amplified by at least two high-profile cases of products adversely affecting consumers in the past five years that have grabbed headlines, scared consumers and raised the ante in the debate over how safe the ingredients in cosmetics are.
In one case, the FDA is investigating Wen hair-care products after it received 127 complaints from consumers and found that Chaz Dean Inc. and Guthy-Renker LLC, the companies that market and manufacture the products, had received 21,000 complaints from consumers about a cleansing conditioner that has allegedly caused significant hair loss, visible bald spots and other adverse side effects.
The current statute does not require companies to share their safety information with the FDA, nor does the law require mandatory reporting of “adverse events.”
In another case, hair strengthening treatments known as the Brazilian Blowout or keratin smoothing formula, were put in the spotlight five years ago after a lab in Oregon found the formulas contained formaldehyde, which is known to cause allegoric reactions like hives, blisters and asthma.
The tests were conducted after stylists at two Portland-based salons complained of eye irritation, nose burning and other symptoms, and submitted samples of the product from their salons to the center.
Groups from opposite ends of the debate over cosmetics regulatory reform have been working together to provide input on cosmetics reform legislation with the FDA and lawmakers for the better part of a decade. While their efforts have led to the introduction of several legislative proposals over the years, no final legislative compromise has been reached.
Many stakeholders believe a compromise between competing Senate and House bills could gain traction, although it is not likely to happen until next year when Congress begins a new two-year session.
“It’s been over 70 years since there’s been significant reform in the area of cosmetics regulation and frankly we haven’t kept pace with other jurisdictions overseas [that] have started to regulate cosmetics in a more robust fashion, so it time and the industry agrees with that,” said John Hurson, executive vice president of government affairs at the Personal Care Products Council, a 600-member organization that includes some of the biggest players in the industry.
“There has been a lot of work done in this Congress and previous Congresses to get to a point where we have a lot of agreement from industry stakeholders, environmental groups, health-care groups and business groups, who believe that it is time to make some changes in the way cosmetics are regulated,” he added.
One bill introduced by Sens. Dianne Feinstein (D., Calif.) and Susan Collins (R., Maine) is considered to have support from many companies in the industry, as well as consumer and health groups. A separate bill in the House, introduced by Rep. Pete Sessions (R., Tex.) has the support from another segment of the industry.
“There is increasing evidence that certain ingredients in personal care products are linked to a variety of health concerns. For example, formaldehyde, which is used in Brazilian blowouts, has been associated with cancer,” Feinstein said in an e-mail. “Despite this, FDA has virtually no authority to review the ingredients in these products. The Personal Care Products Safety Act would change that by requiring the agency to review at least five ingredients per year.”
Feinstein noted that the European Union and Canada have had ingredient review in place for decades, and prohibit or restrict the use of 1,500 and 800 ingredients, respectively. The U.S. prohibits just 11.
“It’s long past time for the United Sates to ensure consumer safety and reform its 80-year-old personal-care products safety laws,” Feinstein said.
The Feinstein-Collins would give the FDA authority to issue mandatory recalls, require companies to report “serious health events” to the FDA within 15 days, require the FDA to test ingredients used in cosmetics and require companies to register with the FDA and provide information about a product’s ingredients.
The bill would also allow the FDA to collect a user fee from manufacturers that the lawmakers have estimated will raise $20 million to pay for the ingredients review and set up a new regulatory system. One of the five ingredients on tap to be reviewed in the bill in the first year is a form of formaldehyde found in the controversial hair-straightening treatments, Brazilian blowout.
In the House, Sessions introduced the “Cosmetic Modernization Amendments Act” last November.
The Sessions bill would establish new procedures and requirements for the registration of cosmetic manufacturing and distributing establishments as well as ingredient statements. It would also require manufacturers, packers and distributors of cosmetics to report serious adverse events. The agency must also establish a program to evaluate the safety of cosmetics and ingredients.
The bill does not give the FDA mandatory authority to recall unsafe products, nor does it impose user fees on companies to pay for the overhaul.
“This legislation reforms and improves the Food and Drug Administration’s ability to streamline and strengthen consumer safety requirements without strangling small businesses in the cosmetic industry with onerous, antiquated regulations,” Sessions said in an e-mail.
The Independent Cosmetic Manufacturers and Distributors, which represents small companies and entrepreneurs, has said it supports the Sessions bill.
“The [Feinstein bill] would basically give FDA the set of modern regulatory tools that the average person probably thinks they already have, and that they have for other products that they regulate like food and drugs,” said Tina Sigurdson, assistant general counsel for the Environmental Working Group.
Sigurdson said women use 12 products a day on average, while men use six and teenage girls use 15.
Officials are hopeful that the process is moving forward toward an eventual compromise.
“I know that stakeholders have been working together for some time to make this happen and that’s why I am optimistic that we will see a change soon,” Sigurdson said.
Hurson said he believes 90 percent of the work has been done to reach a final piece of legislation.
“That being the fact, it is really just a matter of getting Congress the momentum to pick up the pen. You get to a point where all of the interest groups know where they are and it is time for Congress to say they’ve got option a, option b and option c. At some point Congress is going to have to make a decision and we’re very close to that point.”