In December of 2016 FDA published the first new cosmetic guidance document since June of 2014. The draft guidance covers the agency’s recommendation to limit lead in lip and other applied cosmetic products to 10 parts per million (ppm). This action brings FDA guidelines into conformance with the International Cooperation on Cosmetics Regulation, Canada and the European Union, which previously set a limit of 10 ppm for lead as an impurity in cosmetics. FDA notes in the guidance that most of the products they tested in 2011 and 2012 had lead levels lower than 10 ppm.
It is interesting to note that at about the same time FDA published a notice about lead levels in ceremonial and other specialty cosmetics that are used by some Middle Eastern, African and Southeast Asian cultures. This page entitled, Kohl, Kajal, Al-Kahal, Surma, Tiro, Tozali, or Kwalli: By Any Name, Beware of Lead Poisoning, notes that none of these products are legal in the US due to violation of the color additive regulations. The agency has placed these products under import alert and they are to be barred entry into the US.
Other Heavy Metals:
In 2012 FDA also conducted testing on the levels of the heavy metals arsenic, cadmium, chromium, cobalt, mercury, and nickel in eye shadows, blushes, lipsticks, lotions, mascaras, foundations, body powders, compact powders, shaving creams, and face paints. Most products contained very low levels of these heavy metals and FDA has not issued guidance on safe levels of use for these substances in cosmetics.
In July of this year the Microbead-Free Waters Act of 2015 comes into effect. This law amends the Federal Food, Drug, and Cosmetic Act and prohibits the manufacture and sale of rinse-off cosmetics containing intentionally-added plastic microbeads in the US. The statue includes toothpaste in the definition of ‘rinse off cosmetic’ and defines `plastic microbead’ as “any solid plastic particle that is less than five millimeters in size and is intended to be used to exfoliate or cleanse the human body or any part thereof.“
Effective July 1, 2017 rinse off cosmetic products may not be manufactured in the US using plastic microbeads. Such products may not be distributed or introduced into US interstate commerce as of July 1, 2018. The effective dates for products that are both rinse-off cosmetics and nonprescription drugs are July 1, 2018 for manufacturing and July 1, 2019 for introduction into interstate commerce.
It is unlikely that any new FDA Commissioner will greatly increase the number of new guidances or regulations for the cosmetic industry but we’ll keep you updated if they do. In the meantime, let us know what questions you have about cosmetic regulations or topics you would like to read about.