Will the Personal Care Products Safety Act Ensure the Safety of Cosmetics, Salon Products?

Jamie McConnell Director of Programs & Policy

This year, Senators Feinstein (D-CA) and Collins (R-ME) re-introduced the bi-partisan Personal Care Products Safety Act (S. 1113). The bill is intended to fix the deeply flawed system currently in place that is supposed to oversee cosmetic and salon product safety. The system was put in place over 75 years ago (that’s right 75 years ago) and, not surprisingly, a lot has changed in the cosmetics and salon products industry since the Food, Drug, and Cosmetic Act was passed in 1938. The 1940s saw an explosion of chemical manufacturing—with new chemicals being used in everything from plastics to yes, cosmetics.

The core of the problem is that 75 years ago the Food and Drug Administration was not given the authority to require ingredients used in cosmetics and salon products (from hereon when I refer to cosmetics that includes salon products) to be tested for safety. As a result, today it is perfectly legal for cosmetics to contain harmful ingredients like formaldehyde (a known carcinogen), toluene (linked to birth defects), phthalates (also linked to birth defects and reproductive harm), styrene (a carcinogen), and even lead (a potent neurotoxin), to name just a few. What’s more, some of these chemicals can be found in fragrance, yet manufacturers are not required to disclose those ingredients on the product label. And for salon products, manufacturers are not required to disclose any ingredients, besides what may be found in a safety data sheet.

Okay, so back to the Personal Care Products Safety Act. And more importantly, the question is “will this bill ensure the safety of cosmetic ingredients?”. While there are definitely some great things in the bill, there are just too many giveaways to industry that we feel won’t result in meaningful cosmetic ingredient safety. For the most part, the bill is nearly identical to the version that was introduced in the 114^th Congress, with the exception of some exemptions for small businesses.

Areas of Concern

Safety Standard/Substantiation

• Manufacturers can substantiate the safety of ingredients based on “adequate evidence.” Adequate evidence can include an official statement of safety by an official medical or scientific body. There are very few “expert medical or scientific bodies” that produce official statements that cosmetic ingredients are safe as recommended to be used. The few that exist, like the CIR and RIFM, are all paid for and operated by the cosmetic industry itself. Allowing industry to rely on this data to prove the safety of ingredients is a clear inherent conflict of interest. For example, Cosmetic Ingredient Review (CIR) is convened by the Personal Care Products Council, an industry trade group (that also supports the bill). And the International Fragrance Association (IFRA) convenes the RIFM Expert Panel to assess ingredients in fragrance. Not surprisingly, the overwhelming majority of assessments of cosmetic ingredients produced by either body have determined the safety of their use. Given this situation, very little new safety testing or independent safety substantiation of cosmetic ingredients would actually be generated in order to comply with this legislation.

• Manufacturers are not required to meet the safety standard of “reasonable certainty of no harm” that the FDA is required to use to evaluate the safety of the 5 or more chemicals the agency will select to review on an annual basis. Manufacturers are also not clearly required to substantiate the safety of ingredients based on long term health effects such as cancer, reproductive harm, birth defects, etc. Manufacturers should be required to use the same safety standard when substantiating the safety of ingredients.

Fragrance

• Manufacturers would also not have to substantiate the safety of individual fragrance components. In the European Union — where a similar product safety substantiation scheme is already in place — fragrance houses may provide a statement to manufacturers which claims that they have substantiated the safety of the fragrance, without providing any additional information about that specific substantiation process. See here for what a sample fragrance safety substantiation looks like: https://www.cosmeticseurope.eu/publications-cosmetics-europe-association/guidelines.html?view=item&id=77

• Although the bill requires manufacturers to register each cosmetic product and file an ingredient statement with the FDA, the ingredient statement does not require manufacturers to disclose the components of their fragrance ingredients to the FDA. Instead they must simply provide the name or code for the fragrance, and the name of the manufacturer. Knowing that a product contains “Lavender #7 made by XYZ Corp” does not give the FDA enough information to assess what’s in the fragrance mixture. Manufacturers should disclose all fragrance ingredients to the FDA.

Right to Know

• Reports of adverse events or reactions to a cosmetic product reported to the FDA would not readily be made public. Instead, a member of the public would have to submit a Freedom of Information Act (FOIA) request in order to gain information on adverse event reports for a product or ingredient. In contrast, adverse event reports for drugs, medical devices, and toys, are readily accessible. Access to information about a product that has caused harm has a clear public health benefit to consumers nationwide. Cosmetics shouldn’t be treated any differently.

• The safety studies manufacturers use to substantiate the safety of ingredients are not submitted to the FDA, nor will they be made publicly available. The FDA can request the safety studies, but members of the public will not have access to studies. Without making the safety studies publicly available, it’s impossible to verify the veracity of manufacturers’ safety claims.

Adverse Event Report

• Adverse events are defined as a reaction that results in significant disfigurement, including serious and persistent rashes or infections and significant hair loss (the definition was expanded in the re-introduced bill to include hair loss). This definition is very narrow, and doesn’t include respiratory or reproductive health impacts.

• Small businesses are exempt from filing adverse health reports to the FDA, which is very concerning considering small businesses are more likely to have fewer health and safety controls in place (exemption was added to this version of the bill).

What we like about the bill

• Requires manufacturers to register their facilities, products and ingredients with FDA. This will help the FDA better track the facilities, products, and ingredients used to manufacture cosmetic and salon products. It also requires manufacturers to pay a fee to register, which will help to raise 20 million in funds to operate the FDA cosmetics program.

• Closes labeling loopholes by requiring full ingredient disclosure (except for fragrance ingredients) for professional salon products and web-based sales of cosmetic products.

• Requires manufacturers to include contact information directly on the label, including a domestic telephone number or email to report adverse events or to gain more information about product ingredients

• Gives the FDA mandatory recall authority to get unsafe products off the shelves.

• Reverses coal tar’s protected status (found in certain hair dyes). (Coal tar is a carcinogen but current law prevents the FDA from taking action on this chemical for safety reasons, as long as products include a warning label.)

• Directs the FDA to assess a safety of a minimum of 5 cosmetic chemicals a year — included on the list for the first year are methylene glycol/methanediol/formaldehyde, lead acetate, propyl paraben, quaternium-15 (a formaldehyde releaser), diazolidinyl urea (a formaldehyde releaser).

• Requires manufacturers to report adverse reactions to the FDA (currently if manufacturers receive an adverse event report from a salon worker/consumer they are not required to pass that information on to the FDA).

So, with a few tweaks, this bill is essentially the same as what was introduced in the last congressional session. And while it is great to see members of Congress taking on this issue, there are areas where it needs to be strengthened.  We recognize that this is a compromise bill and not everything advocates want will be included. However, if we want a system better than what we have now, at the very least the bill must be amended to require manufacturers to meet an adequate bar of safety, including for fragrance ingredients, an area where the industry has received a pass on for too long.

Join us in urging Senators Feinstein and Collins to make the necessary changes to this bill so that we can truly protect the health of salon workers and consumers from exposure to harmful ingredients in these products.