The Sunscreen Innovation Act does not relax the FDA’s scientific standards for evaluating safety and effectiveness of sunscreen ingredients. It also does not reduce the amount of adequate and relevant data on which to base FDA determinations regarding sunscreen ingredients. Rather, the regulatory process known as a time and extent application process, or “TEA”, for short, allows manufacturers to request that the FDA inspect certain active ingredients in over-the-counter (“OTC”) products. This process is mostly used when a manufacturer is able to sell an OTC product in foreign countries, but not the United States.

The first step of the TEA is for a manufacturer to prove to the FDA that it has been selling their product, with the requested active ingredient, as an OTC in one or more countries for a certain amount of time and in a manner consistent with the way it would be used in the United States. Next, the FDA will evaluate the available data on the active ingredient to determine whether it is safe for OTC use. The FDA evaluates the data submitted to determine whether an active ingredient is generally recognized as safe and effective (GRASE) for its intended use. If an ingredient is found to be GRASE, then it can be sold OTC in the United States.

Before the Act went into effect, there were 8 TEAs submitted to the FDA for review. On January 7, 2015, six (6) of the eight (8) ingredients were classified as not GRASE for use in sunscreens because more data was needed from the manufacturers to help establish the safety and effectiveness of these ingredients. On February 24, 2015, the final two (2) ingredients were also classified as not GRASE by the FDA for the same reasons as the others, in that more data was needed to demonstrate safety and effectiveness for OTC use.

As the Sunscreen Innovation Act and FDA regulation of sunscreen illustrates, even though some products may be legally sold in other countries, they may still be banned or heavily regulated in the United States. The United States has very stringent controls in place to ensure the highest quality and safety of products sold to consumers. If you are selling a product that is to be ingested or applied to the skin, it can be a difficult process to figure out which rules apply to your product and what procedures must be undertaken in order to safely get your product to market.

We offer assistance with premarket review, label reviews, and ensuring that your product complies with FDA regulations. If you would like assistance with your products, please contact us at contact@sglawfl.com.

The proposed rule is part of the FDA’s ongoing review of the safety and effectiveness of the active ingredients in antibacterial soaps and related products, which are not found in non-antibacterial, or plain, soap. Further, as noted above, these products are regulated as OTC drugs, etc., as opposed to soaps generally, which are typically regulated as cosmetics by the FDA. As far as the ingredients found in these antibacterial products, the FDA notes that new data suggests that long-term exposure to certain active ingredients—primarily triclosan and triclocarban–in antibacterial products poses health risks such as hormonal effects and resistance to antibiotics. Also, according to the FDA, there is no evidence that antibacterial soaps and hand washes are more effective at preventing illness and reducing infection than plain soap and water.

If finalized, the rule would require manufacturers to submit additional evidence that the active ingredients in antibacterial soap and other products are safe for repeated daily use and provide a clinical benefit as compared to non-antibacterial soap and water. Specifically, the risk must be balanced by the clinical benefit to establish that the OTC antibacterial active ingredients are generally recognized as safe and effective (GRASE) for their intended use. Otherwise, to continue marketing the products, manufacturers would need to remove the antibacterial active ingredients from the product and the antibacterial claims from the product’s labeling. Accordingly, if finalized, the rule would require both formulation and labeling changes for those companies marketing these products.

In sum, the proposed rule will be available for comment for 180 days, until June 16, 2014, with a concurrent one-year period for companies to submit new data and information. If you have any questions about this announcement, GRASE status, or compliance with any FDA regulations pertaining to cosmetics or OTC drugs and need a food and drug (FDA) lawyer, please contact us at:  contact@sglawfl.com.