Senate Personal Care Product Safety Act of 2015

Most people assume cosmetics and personal care products are tested for safety before being stocked on store shelves. In truth, personal care products are one of the least regulated industries in the U.S. On April 20, 2015, Senators Dianne Feinstein, D-Calif., and Susan Collins, R-Maine, introduced the Personal Care Products Safety Act of 2015. The bill seeks to reform a $71 billion industry that is currently regulated by approximately two pages of federal law that has only been updated once in the past 76 years. Strong provisions in the bill would advance the FDA’s ability to protect Americans’ health by improving current law in the following areas:

– Directing the FDA to assess the safety of a minimum of five cosmetics chemicals a year;

– Requiring companies to register their facilities, products and ingredients with the FDA;

– Requiring companies to comply with good manufacturing practices;

– Closing labeling loopholes by requiring full ingredient disclosure for professional salon products and web-based sales of cosmetic products; and

– Giving the FDA mandatory recall authority to get unsafe products off the shelves. 

However, strengthening amendments are needed in the following areas:

– Strengthen the bill’s weak safety standard MORE...

The breadth and depth of the bill’s safety standard, used by the FDA to assess the safety of 5 or more cosmetic chemicals a year, needs to be more robust. In its current proposed form, it applies only to the FDA and not to manufacturers who will be responsible for the lion share of safety substantiation; and lacks clarity regarding the protection of vulnerable populations including workers. It also does not provide clear direction on the long term, chronic health endpoints that should be considered in safety assessments, including but not limited to cancer, reproductive and developmental harm.

– Industry self-certification of safety needs to be more robust MORE...

The bill falls short of what is needed to elevate the rigor of ingredient safety reviews conducted by cosmetics companies. In key areas, it preserves the status quo – industry-led safety assessments benchmarked by industry-funded science. This is essentially the same inadequate system we have in place now. Industry safety substantiation of cosmetic chemicals should be based on the same safety standard used by the FDA. With the exception of a few ingredients, the bill’s provisions miss key opportunities to shore up the safety of cosmetic and personal care products.

– Fragrance ingredients should not remain a mystery MORE...

The bill exempts fragrance and flavors from FDA ingredient disclosure, which means the FDA will not be getting the information it needs to effectively regulate cosmetic ingredient safety.  Fragrance chemicals are also kept secret from manufacturers and consumers, making it impossible for manufacturers to fully substantiate the safety of all of the ingredients in their own products. Because 40% of personal care products include fragrance, this means almost half of all products on the market today will not be fully assessed for safety.  Consumers have an urgent right to full disclosure of all, and not just some, of the chemicals in their cosmetics and personal care products so they can make safer, more informed purchases.

– Data sharing of safety studies should be required MORE...

Cosmetics manufacturers and suppliers of ingredients, raw materials and fragrance should be required to submit their safety studies to the FDA, which should then make them publicly available. Industry data sharing of safety studies will result in less animal testing, will help small businesses and will increase the number of cosmetic chemicals the FDA is able to substantiate for safety.

– Provide consumer-right-to-know about cosmetic products causing adverse reactions MORE...

The bill does not require that adverse and serious adverse events reported by cosmetic manufacturers be made public. Adverse reactions to drugs, medical devices, even toys are publicly available. The public has a right to know if a cosmetic product is causing adverse or serious adverse events like hair loss, burns, disfigurement, and more.

– Remove federal preemption MORE...

States are preempted from establishing legislation to address the registration, good manufacturing process (GMP), recalls and adverse event reporting of cosmetic products; and preempted from adopting legislation or regulation addressing the safety of chemicals under safety review by the FDA.  States have led the way and should retain the right to protect their citizens from unsafe chemical exposures from cosmetics and other consumer products.

The Breast Cancer Fund’s Campaign for Safe Cosmetics has taken the lead to organize concerned consumers, businesses, workers and NGO’S on behalf of amending the bill to make it as truly  health-protective as possible.

More information on the legislation:

If you would like more information about the bill, or want to get more involved, please email

FDA’s Lack of Authority

The Federal Food, Drug and Cosmetics Act (FFDCA) includes 112 pages of standards for food and drugs, but just a single page for cosmetics. The cosmetics title of the FFDCA, which has not been amended significantly since it was enacted more than 75 years ago, provides virtually no power to perform even the most rudimentary functions to ensure the safety of an estimated $71 billion cosmetic industry.

What the FDA Cannot Do

  • Require companies to conduct pre-market safety testing of cosmetics products and ingredients.
  • Review or approve cosmetic products or ingredients before they are sold to the public.
  • Effectively and efficiently regulate cosmetics products without facing cumbersome legal proceedings with manufacturers.
  • Require product recall. The agency must go to court to remove misbranded and adulterated products from the market.
  • Require manufacturers to register their cosmetic establishments, file data on ingredients or report cosmetic-related injuries. Instead, FDA relies on voluntary reporting of ingredients, injuries and establishments.

What the FDA Does Not Know

  • The overall number of ingredients in personal care products.
  • The ingredients in a particular product that lists “fragrance” as a mask for dozens of component chemicals.
  • The number and location of companies that manufacture and distribute personal care products. The FDA’s primary enforcement tool is facility inspections, but they can’t inspect facilities they don’t know exist.
  • The extent of health impacts from harmful ingredients. Companies are not required to report adverse health effects to the FDA or share studies they may have conducted on chronic health effects.
  • The presence or potential health impact of nanomaterials in cosmetics.

Cosmetic Ingredient Review (CIR)

In the absence of government authority, the safety of personal care product ingredients is evaluated through a voluntary industry program known as the Cosmetic Ingredient Review process. Not only is this program run by the very industry it is intended to oversee, but compliance with CIR recommendations is totally voluntary. The CIR has reviewed less than 20% of the FDA estimated 12,500 chemicals used in cosmetics, and of those the CIR has reviewed, they have found only 9 chemicals unsafe for use in cosmetics. What safety data does exist focuses on acute reactions to products, such as skin rashes or allergic reactions, as opposed to studies that look at chronic health effects from chemicals in personal care products, like cancer, reproductive or nervous system effect that are driven by genetic susceptibility, the timing of exposure, and aggregate exposures over a lifetime.

FDA’s Voluntary Cosmetic Registration Program (VCRP)

The VCRP collects information on product ingredient listings and registration of manufacturers, packers and distributors. Again, participation in the program is entirely voluntary.

  • FDA estimates 12,500 cosmetic ingredients, and a similar number of fragrance ingredients, but has formal records for only 4,066. Environmental Working Group has documented 8,821 unique ingredients in their online product database (
  • FDA estimates that cosmetics are manufactured in more than 1,400 domestic establishments. However a GAO study stated: “Because FDA cannot mandate participation, it cannot accurately assess how many companies may be avoiding registration.”

PCPC’s Consumer Commitment Code

The Personal Care Product Council (PCPC) is the cosmetics industry trade association. The PCPC’s Consumer Commitment Code encourages voluntary reporting of adverse health events. Companies are asked to report “serious and unexpected adverse consumer experiences with cosmetic products.” However, not only is the program voluntary, but FDA must pro-actively file a written request for the information “based on an explicit, legitimate and specific safety concern or question related to the product” and inspect the safety information summary at “a mutually agreed upon location.” This process requires the FDA to spend scarce resources filing formal requests for information that should be submitted to them automatically given the threat to public health presented by adverse health events associated with cosmetic use.


For more information, please contact Janet Nudelman, Breast Cancer Fund,