US FDA Update: Regulation of Soap and Lead Limits in Cosmetics
Lead limit in cosmetics introduced
The United States Food and Drug Administration (FDA) has issued draft guidance on safe lead limits in cosmetics marketed in the U.S. The advice is the first time that the FDA has suggested an acceptable limit for lead concentration in cosmetic products.
Which cosmetics are affected?
The guidance covers all externally applied cosmetics (including shampoos and body lotions). It is not just restricted to lipsticks, where ingestion of lead is more arguably a potential health issue especially in teenagers or children. In general, products that contain colors frequently contain metals among which lead may be a minor contaminant.
What is the recommended lead limit?
The FDA recommends lead content of no more than 10 parts per million (ppm) in a product. New analytical detection methodology enables detection of less than 0.1 ppm.
While the FDA's guidance does not establish legally enforceable responsibilities and need only be viewed as a recommendation, it is our view that the potential impact of this new regulatory approach should not be underestimated. The new guidance should be considered with the knowledge that lead already has a reputation as a health hazard and that other jurisdictions (e.g. Canada and the EU) have adopted similar acceptable limits.
Many US cosmetic manufacturers may not previously have measured the lead content in their products because they lacked appropriate detection methods. Instead, manufacturers may have relied on recipes and certificates from color suppliers. Cosmetic manufacturers should now consider doing so. Manufacturers might consider identifying contract analytical laboratories or the development of internal analytical capability.
The guidance is stated to be open to further comment. We would be happy to help our clients understand the impact of this new regulatory approach and assist in the preparation of comments.
Change to regulation of soap products?
The Food and Drug Administration (FDA) has chosen to interpret what meets the definition of a soap very narrowly. If the United States' courts were no longer to give weight to the FDA's interpretation that would have a significant impact on the current regulation of the content and labeling of products with a soap function such as toothpaste, shampoos and other comparable products.
When is a soap a cosmetic?
Soap products are regulated in one of three ways depending upon whether they are classed as a soap, cosmetic or drug. Soaps themselves are specifically excluded from the ambit of the Federal Food, Drug and Cosmetics Act and thus completely outside the scope of FDA regulation. If the product is classed as a cosmetic while it is subject to fairly light touch regulation, the FDA has gradually increased its oversight of ingredients, other additives, manufacturing quality and labeling. Drugs require pre-approval for marketing authorization under rigid criteria.
Broadly, the FDA has indicated that if a product consists almost exclusively of detergents, that are, or primarily of alkali salts of fatty acids, the product is a soap. Any other product, if labeling is limited to a physical and not physiological action, and is intended not only for cleansing but also for other cosmetic uses, is regulated as a cosmetic. Examples of cosmetic uses include making the user more attractive, by acting as a deodorant, imparting fragrance to the user, or moisturizing the skin. The FDA has previously indicated that some shampoos, for example those with other cleansing actions such as scrubs or fragrances, may not be soaps but cosmetics.
What is changing?
A draft bill, if enacted in its current form, would change the way that U.S. courts consider regulatory agencies' legal interpretations when the application or interpretation of that law is at issue. Currently the courts apply the Chevron doctrine which provides that interpretations of law by regulatory agencies are given weight by the courts. The bill effectively proposes abolishing the doctrine.
What is the potential impact of the change?
The FDA's view of what counts as a soap would be unlikely to prevail if the Chevron doctrine were abolished. While this amendment did not go far in prior Congresses, the change in control of Congress and the White House might change its prospects. An Omnibus budget bill is anticipated this year to which the proposal to abolish the Chevron doctrine could be attached. Omnibus budget bills are not subject to the requirement for a super-majority vote and would not need Senate approval as filibuster is barred.
Abolition of the doctrine could have a significant impact on items such as toothpaste, shampoos and other comparable products by eliminating the agency's ability to enforce its views. Stated differently, many of the products currently available in Europe, but not available in the US, might more readily be imported. Similarly, production costs and more limited regulation might have an effect on domestic pricing and variety of offerings. The argument in favour of FDA regulation would be maintenance of consumer safety although fragrance and other ingredient safety is well understood.