Product Regulations in the U.S.
Pre-Market Approval
With the exception of disinfectants, saniziters, and color additives, products in the US do not need pre-market approval. That means many cosmetics, personal care products products, household cleaners, and even menstrual products have not been vetted and approved for safety.
However, each category of products does have a different set of regulations.
Household Cleaning Products
Generally, household products are not regulated because no federal agency has the authority to collect information on their chemical content. Some cleaning products will list ingredients, others will not. The Federal Hazardous Substances Act requires labeling on hazardous household products indicating how to safely store and use the products and first aid information. The Environmental Protection Agency (EPA) regulates disinfectants and sanitizers by requiring companies to test them for efficacy, stability, and toxicity, and to give explicit directions for use on the label.
Cosmetics and personal care products
Cosmetics and personal care products do not need pre-market government approval, with the exception of color additives other than coal tar hair dye. The FDA does require all ingredients to be listed on the label with the exception of fragrance ingredients. Fragrance is considered a trade secret and companies are not required to list the ingredients in the fragrance. Learn more about why you should avoid products with fragrance here.
Menstrual Products
Companies are not required to disclose the ingredients in menstrual hygiene products such as tampons, pads, and cups. However, in 2019 New York passed legislation requiring companies to disclose all ingredients in tampons and pads.
Modernization of Cosmetics Regulations Act of 2022
The Modernization of Cosmetics Regulations Act (Title VIII of the “Food and Drug Administration Safety and Landmark Advancements Act of 2022”) is the first legislation to change cosmetic regulations in the US since 1938.
Here are the highlights from the legislation:
Reporting of Adverse Events
Whenever adverse health events occur, companies must now report them to the Secretary of Health and Human Services ("Secretary") within 15 days and keep records of adverse events for six years. However, exemptions are allowed if it would have no significant adverse effect on public health. If there is reasonable grounds to believe fragrance or flavor has caused an adverse event, the Secretary can request a list of the fragrance ingredients to be provided within 30 days. Unfortunately, companies are still not required to list fragrance ingredients on packaging. Read more about why I recommend avoiding fragranced products here.
Good Manufacturing Practices
Consistent good manufacturing practices will be established and regulated within 2-3 years. These will be flexible for businesses of different sizes and are done with the intention of ensuring products are not adulterated.
Product Registrations
Facilities that manufacture or produce cosmetics must now be registered. Product listings must be submitted to the Secretary, updated annually, and include where the product is manufactured, the applicable categories, and the person responsible. Products that are the same with the exception of different colors, fragrances or flavors, or quantity of contents, can go under one listing. This does not give full transparency on products since different flavors and fragrances are made of many different ingredients.
Facilities can be suspended if cosmetic products registered there might reasonably cause an adverse event.
Safety Substantiation
Previously
The FDA website stated “Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.” “The law also does not require cosmetic companies to share their safety information with the FDA.”
Now
Companies must maintain records showing adequate substantiation of safety of their cosmetic products. "Adequate safety substantiation" is described as "tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe." Ingredients that would not be considered unsafe are those that cause minor and transient skin irritations in some users, though the Secretary may consider cumulative exposure if appropriate and available.
It remains vague what will be considered unsafe, so it is still important for us to determine what is inside products and whether or not they are safe.
Product Labels
Fragrance allergens must be identified on the label, though the Secretary may establish threshold levels of amounts of substances subject to disclosure.
This means that there still may not be full disclosure in certain circumstances.
Product Recalls
Previously
Up until the Modernization of Cosmetics Regulations Act of 2022, the Secretarylacked the authority to recall products. When products were deemed harmful, it was up to companies to choose to recall the product or not.
“Recalls of cosmetics are voluntary actions taken by manufacturers or distributors to remove the marketplace products that represent a hazard or gross deception ,or that are somehow defective.” 21 CFR 7.40(a).
Unfortunately, companies did not always recall unsafe products even after many complains. For example, after the FDA found asbestos in Johnson & Johnson talc baby powder, Johnson & Johnson continued to sell the powder for years. Another example is Wen haircare. Wen had thousands of complaints of hair loss or scalp irriation yet the products remain on the market. Claire’s adolescent makeup was reported to contain asbestos in 2017, and it wasn’t until 2019 that FDA ran tests confirming this. Claire’s eventually voluntarily recalled the products.
Now
If there is a reasonable probability that a cosmetic is harmful, companies are first given the opportunity to recall the product and cease distribution. If the responsible party decides not to issue a recall, then the Secretary can require them to do so if they chose.
This is a notable change, as previously recalls were strictly voluntary. However, it is important to note that there is no mention of a process to ensure that recalled products are pulled from the shelves.
Talc & PFAS
Talc is used in everyday products like deodorant, eyeshadow, powder, foundation, and even supplements. For decades, asbestos (a carcinogen) has been a known potential contaminant of talc due to how it is mined. Yet products with talc remain on shelves today. The legislation will establish standardized testing for detecting asbestos in cosmetics with talc within 18 months. Read more about why you should avoid products containing talc here.
Per- and polyfluoroalkyl substances (PFAS) are a group of over 9,000 chemicals used in the manufacture of water-repellant personal care items and fabrics, non-stick cookware, polishes, paint, wax, cleaning products, firefighting foam, microwave popcorn bags, floss, and even some menstrual underwear. PFAS are toxic to the cardiovascular system and linked to adverse health effects. The safety of PFAS in cosmetics will be assessed and a summary of the findings will be published on the FDA website within 3 years of the legislation. Learn more about why PFAS are harmful plus how to avoid them here.
Other US Product Regulations
Kids’ Pajamas
Regulation for kids’ pajamas actually does more harm than good. Under US law, kids’ pajamas from 9 months to size 14 must be flame resistant or tight fitting. This dates back to a law from the 1970s to protect kids from burns by candles and space heaters. To comply, manufacturers treat fabrics with flame retardants including halogenated hydrocarbons (chlorine and bromine), inorganic flame retardants (antimony oxides), and phosphate based compounds. Flame retardant are linked to reproductive toxicity, endocrine and thyroid disruption, immune system impacts, cancer, and adverse effects on fetal and child development and neurologic function. Because of this, it is best to choose snug-fitting cotton pajamas which doe not have flame retardants.
Conclusion
The onus is on us to determine the safety of products we use by asking questions & doing our own research.
