Increased scrutiny of anti-aging products with sunscreen ingredients entering the U.S. presages "a major enforcement initiative" against personal care product firms making noncompliant claims, according to a food and drug attorney who worked at FDA on import enforcement.

"We've had quite a number of clients running into problems with the compliance officers," said Benjamin England, founder of regulatory consulting firm FDAImports.com, and former regulatory counsel in FDA's Office of Regulatory Affairs.

Specifically, FDAImports.com has seen increased action against products containing sunscreen ingredients approved for use in Europe or Asia but not monographed in the U.S.

"That's sort of typical. FDA looks at that and says, 'That's not compliant with the monograph, which makes it an unapproved drug,'" England said.

Based on discussions with FDA officials, England said he expects OTC and cosmetics manufacturers and importers of all sizes "will likely see increased enforcement on labeling compliance generally and drug claims in particular."

Firms should expect "a notification to the industry reminding companies about the importance of complying with all labeling requirements for topical cosmetics and over-the-counter drugs," according to England. The reminder also likely will consist of a number of warning letters sent out to offending manufacturers and distributors, the lawyer said.

He expects large global companies to receive some of the warning letters, which would "bring a measure of parity to FDA's enforcement practices."

England observes the agency's enforcement activity in the past has targeted predominantly small cosmetics firms. "It's as if ... FDA has given multinational companies a 'Get Out of Jail Free' card on importing cosmetics bearing these kinds of claims," he said.

While at FDA, England spearheaded the agency's integration efforts with U.S. Customs and Border Protection, according to his firm's website. He left FDA in 2003.

FDA Dusts Off 1988 Guidance

He said FDA also is starting to enforce language from a 22-year-old import alert guidance related to anti-aging skin care products.

Import alert #66-38 issued in June 1988 - entitled "Skin Care Products Labeled as Anti-Aging Creams" - listed firms targeted with regulatory letters for making "exaggerated" anti-aging claims, which rendered their products new drugs under FDA regulations.

"Examples of such claims are that the products 'counteract,' 'retard' or 'control' the aging process," the agency said. "Claims that the product will 'rejuvenate,' 'repair' or 'restructure' the skin may also be drug claims," the alert said.

FDA offered a claim in full - "Molecules absorb and expand, exerting upward pressure to 'lift' wrinkles upward" - as an example of one suggesting an "inner structural change" that would qualify the product as a drug.

The agency republished the alert in April 2010, updating its "Yellow List" of companies that have received regulatory letters for claims overstepping cosmetics boundaries. The list includes importers as well as manufacturers and shippers, FDA notes.

The updated alert includes guidance to field agents: "All entries of skin care products imported by the firms or manufactured/shipped by the firms on the Yellow List for this alert should continue to be checked for drug claims until a district is convinced the firm's products are in compliance."

U.S. firms Estee Lauder, Avon, Revlon and Hain Celestial are cited, as well as Coty, Elizabeth Arden, France-based L'Oreal and Clarins, German firm Beiersdorf and Japanese firm Shiseido.

"We keep tabs on import alerts that are relatively active where the FDA starts adding companies and products to it, which is indicative of a trend that the agency is starting to focus on," England explained.

"What I find is that when FDA starts to increase enforcement at the border, it's a forecast of things to come," the attorney said. "In fact, a lot of times they'll do this kind of review [and] start focusing on imported cosmetics or cosmetic ingredients ... in order to sort of survey what's going on in the industry."

FDA has increased reviews of imported cosmetics and "has been detaining more shipments of cosmetic products bearing impermissible drug claims," FDAImports.com says.

England noted the action is occurring in multiple ports around the country, "which gives the indication that the agency is operating on some uniform guidance internally."

Columbia, Md.-based FDAImports.com's cosmetics clientele is divided roughly between foreign manufacturers and importers, either of whom can incur costs if a product is denied entry to the U.S. market.

Parallels Front-Of-Package Nutritional Reform?

England said an initiative to rein in anti-aging skin care claims could play out like the front-of-package food labeling initiative formally introduced by FDA in March.

Led by Commissioner Margaret Hamburg, the agency warned 17 manufacturers their food products "violate provisions [requiring] labels to be truthful and not misleading," according to FDA.

The action stemmed in part from questions raised by industry-sponsored programs such as Smart Choices , which was applied to such selections as Kellogg's Froot Loops . FDA's warnings to food manufacturers were announced roughly five months after an October 2009 statement encouraging firms to review their labeling to ensure compliance with regulations (¹ 'The Tan Sheet' May 3, 2009, In Brief).

According to England, there could be a recall risk associated with FDA's move against unlawful cosmetics claims that the food industry may not face under the nutritional labeling initiative.

Many of the warning letters to food firms cited labels that claimed "no trans fat" but did not alert consumers to "significant levels of saturated fat and total fat."

England noted that "they don't like you saying 'zero trans fat,' [but] that's probably not a recall. But if you have an unapproved drug on the market, that might be."

- Ryan Nelson ( ² r.nelson@elsevier.com )

FDA Crackdown On Anti-Aging Imports Signals "Major Enforcement Initiative"

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