On July 14, 2011, FDA posted an update on how it regulates cosmetic products.  The full update is below for your perusal. In my practice, I have seen warning letters from the FDA, refusals and the insertion of companies on FDA’s Import Alert List (goods are automatically detained when entering the U.S., and it is up to the importer to prove to the FDA that the products are in compliance for EACH importation).  It will be interesting to see if the FDA ramps up enforcement for violative cosmetics.  Interesting to note is FDA’s newer Import Alert (IA) for cosmetic products – IA  66-38, “Skin Care Products Labeled As Anti-Aging Creams,” dated April 8, 2011.  Getting off the Import Alert list is a rather rigorous process, which will be the subject of another post.  Interested to note if you see ramped up enforcement of cosmetics with the new administration?

How FDA Evaluates Regulated Products


The Food and Drug Administration’s Strategic Action Plan for Risk Communication is an initiative to tell consumers how the agency makes decisions on the safety and effectiveness of FDA-regulated products. This is the first in a series of articles about the data and methods—and their limitations—that FDA uses to determine whether products are safe for consumers to use.


Here’s a look at how FDA’s Office of Cosmetics and Colors evaluates the safety of cosmetics.

The Regulation of Cosmetics:

Under the Federal Food, Drug, and Cosmetic Act, cosmetic products and ingredients do not require FDA approval before they go on the market. The exception is color additives (other than those used in most hair dyes). Companies and individuals who market cosmetics have the legal responsibility to ensure the safety of their products.

To learn more, see FDA Authority Over Cosmetics.

Safety Data and Its Limitations


FDA can only act after a cosmetic is on the market and then must first establish that the product is harmful to consumers when used as intended. The agency has ways to monitor these products but even so, the information is often limited:

  • Voluntary Cosmetic Registration Program: FDA encourages cosmetic firms to report product formulations through the VCRP. The VCRP database provides important information on these cosmetics. However, the companies are not legally required to tell FDA about their products and safety data.
  • Inspections: FDA can inspect manufacturing facilities to determine if proper controls and practices are being followed. FDA also works with U.S. Customs and Border Protection to examine imported cosmetics. But because resources are limited, only a few establishments are inspected each year, and just a fraction of imports are physically examined.
  • Surveys of products: FDA periodically buys cosmetics and analyzes them, especially if aware of a potential problem. The information obtained can be used to alert consumers, support regulatory actions, or issue guidance for industry. FDA does not have the resources to sample and analyze all cosmetics on the market.
  • Cosmetic Ingredient Review (CIR) expert panel: The CIR is an independent, industry-funded panel of medical and scientific experts that meets quarterly to assess the safety of cosmetic ingredients. The limitations are that CIR bases its reviews on summaries provided by manufacturers, not the complete data sets from safety testing, and reviews only a limited selection of ingredients each year. FDA may or may not agree with CIR conclusions.

FDA’s Own Research


FDA conducts research on cosmetic products and ingredients to address safety concerns or to provide information to support regulatory actions or guidance. For example, the agency has conducted research on skin absorption of cosmetic ingredients, tattoo inks, and potential contaminants.


In considering the safety of a product, a number of factors are considered, such as:

  • whether a cosmetic is likely to be inhaled, swallowed, or absorbed through the skin
  • how often it is generally used
  • how long it stays in contact with the body (for example, leave-on or wash-off)
  • whether some people, such as children, the elderly, or people with compromised immune systems, might be more vulnerable than others 

FDA also looks for input from consumers and health care providers. If you experience a bad reaction to a cosmetic, please contact FDA’s problem-reporting program, MedWatch2, on the Web or at 1-800-332-1088; or contact the consumer complaint coordinator3 in your area.


Because the law does not require that bad reactions to cosmetics be reported to FDA, the agency may be unaware of problems. That’s why FDA is trying to increase consumer awareness about the importance of reporting cosmetic-related problems. (See Bad Reaction to Cosmetics? Tell FDA.4)


What Can FDA Do if a Cosmetic Is Not Safe?


To prevent further shipment of a cosmetic that does not comply with the law, FDA may 
  • ask a federal court to issue an injunction
  • request that U.S. marshals seize the products
  • initiate criminal action
  • refuse entry of an imported cosmetic
  • request that a company recall a product

FDA cannot require recalls of cosmetics, but works with companies to make sure their recalls are effective.