FDA Advisors Disapproving Cosmetic Claims

With numerous products promising myriads of skincare benefits, it can be difficult to make a choice if you are planning to buy. Most products these days come with slogans and stickers claiming to reverse the ageing process or protect you from the sun. Do they actually work? FDA advisors do not think so, which is why they are exerting effort to make cosmetic brands remove their claims.

According to fda.gov, "Improperly labeled or deceptively packaged products are considered misbranded and subject to regulatory action. Under the FD&C Act, a cosmetic is considered misbranded if:

- Its labeling is false or misleading in any particular;

- Its label does not include all required information;

- The required information is not adequately prominent or conspicuous;

- Its container is so made, formed, or filled as to be misleading;

- It is a color additive, other than a hair dye, that does not conform to applicable regulations issued under section 721 of the FD&C Act; and

- Its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970." (FD&C Act, sec. 602)

The FDA's legal authority over cosmetics differs from drugs, biologics, and medical devices.Still, it may administer their initiative against products or firms and individuals that do not comply to their guidelines. Because FDA does not approve cosmetic products does not mean they will not be intervening with distribution.

According to FDAImports.com LLC founder Benjamin England, it is illegal to state that a product has SPF, anti-aging or anti-wrinkle properties. This is why FDA advisors have announced that a major initiative will be taking place against cosmetic companies with product labels bearing these prohibited claims. The FDA has been issuing import alerts on these claims since 1988 for both US and non-US based companies.

As of April 2010, the FDA has added as many as 93 products and 4 businesses to the IA 66-38 or "Yellow List." The companies subjected to this import alert will be under exhaustive FDA surveillance and increased import field examinations. With the new initiative, all cosmetic companies will be able to sense the increased implementation on product claims and labeling compliance.

Recently, the FDA has been detaining more product shipments, increasing its reviews, and notifying industries and companies on the importance of complying with labeling requirements. Failure to conform will result in receiving FDA Warning Letters, alleging the products as misbranded articles or unapproved drugs. According to the FDA, one of their goals for this operation is to achieve uniformity during their enforcement practices, since it appears that they have been targeting smaller companies in the past.