AHA Labeling Proposal Tops CFSAN's Cosmetics Priorities "A" List

The development of labeling for alpha hydroxy acid-containing products is at the top of the FDA's Center for Food Safety & Applied Nutrition's cosmetics "A" list of priorities released Feb. 7.

Labeling, which would communicate the importance of using sunscreen with the ingredient family, was discussed in December between FDA and the Cosmetics, Toiletry and Fragrance Association (¹ ).

The importance of using sunscreen with AHAs was first communicated at the time of the Cosmetic Ingredient Review board's 1996 review of the ingredient. CIR recommended AHA products either be formulated to not be sun-sensitive or contain labeling stating the need to use sunscreen.

In addition to the labeling initiative, FDA noted it would continue to support the National Toxicology Program's long-term AHA photocarcinogenicity test, which is expected to take years to complete.

AHAs led the center's 1999 priorities list, through which the agency vowed to complete the ingredient's safety review to determine whether a public risk exists (² (Also see "CFSAN Priorities List For 1999 Includes Four Cosmetics Issues" - HBW Insight, 1 Feb, 1999.)). The Office of Cosmetics & Colors completed the collection of "clinical information" last year, with the goal for 2000 "to look at options for public health," FDA said.

In its study, the agency concluded glycolic acid causes a short-term increase in skin sensitivity to the sun. However, sensitivity returned to baseline after ending use of the acid and caused no statistically significant DNA damage (³ (Also see "Glycolic Acid Increases Short-Term Skin Sensitivity To UVB Rays - FDA" - HBW Insight, 13 Sep, 1999.)).

For 2000, AHAs are categorized under the "cosmetic ingredient safety heading," which also includes continued support of NTP's safety study on beta hydroxy acids and its own diethanolamine safety review. Cosmetics enforcement and the Voluntary Cosmetic Registration Program round out the "A" list.

CFSAN's DEA priorities for 2000 call for a completion of the risk assessment evaluation - which was slated for completion by the end of 1999 - and development of risk management approaches. "We need to...see what regulatory steps to take, if any," FDA said.

The agency's Cancer Assessment Committee completed its evaluation of an NTP dermal carcinogenicity study of DEA and three DEA-derived cosmetic ingredients in 1999, according to a memo from CFSAN Director Joseph Levitt highlighting program accomplishments.

Under the second item on CFSAN's priority list, cosmetics enforcement and surveillance, FDA said it is developing a strategy for issuing warnings for products formulated with ingredients that lack adequate safety substantiation.

The category also includes the development of a strategy for issuing untitled letters for labeling violations. FDA earlier called the untitled letters, which would be sent to a company in cases of less severe violations, a "perfect fit" for the cosmetics program (⁴ (Also see "FDA "Untitled Letters" A "Perfect Fit" For Cosmetics Compliance Program" - HBW Insight, 1 Mar, 1999.)).

The third "A" list priority is continued restoration of the Voluntary Cosmetics Registration Program. CFSAN proposes designing a Web-based, interactive registration system for streamlining VCRP and is considering the feasibility of participation incentives.

One incentive may be a certificate of participation, which could be a tangible benefit to businesses involved with the program, Office of Cosmetics & Colors Director John Bailey, PhD, noted at CTFA's science conference (⁵ (Also see "VCRP Reporting Incentives To Boost Industry Participation Considered By FDA" - HBW Insight, 15 Nov, 1999.)).

Other incentives could include a registration feature to check ingredient nomenclature or e-mail news updates. FDA reinstated the VCRP program when funding for the cosmetics office was restored by Congress (⁶ (Also see "Voluntary Cosmetics Registration Program Reinstated With No Changes" - HBW Insight, 11 Jan, 1999.)). VCRP also was included as a 1999 CFSAN priority.

Of the four 1999 "A" list of priorities, cosmetics program restoration is the only topic absent from the 2000 list. In 1999, FDA developed and implemented a plan to restore $2.5 mil. to the cosmetics program while restoring staffing levels and recruiting new personnel.

In an effort to align the priorities with FDA's fiscal year, the 2000 list is intended to be a nine-month plan ending Sept. 30. "That means we have only three quarters of the year to do the work so our goal will be to complete three quarters of the 'A' list items in that nine months," Levitt said.

CFSAN also released a "B" list of priorities, led by cosmetics labeling and ingredient nomenclature. FDA anticipates completing review of the ingredient dictionary and developing a proposed regulation for cosmetic ingredient nomenclature. The agency also will "assess the feasibility of establishing a U.S. cosmetics ingredient inventory."

The second "B" list priority, cosmetic enforcement and surveillance, includes the creation of a "streamlined case development process" within the Office of Regulatory Affairs and the Center for Drug Evaluation and Research.

Consumer and industry assistance, another "B" list topic, proposes plans to "update and enhance" the cosmetics Web page and complete a revised Cosmetics Handbook.

International harmonization ranked fourth on CFSAN's "B" list of priorities. While the category is an increasingly growing area of interest for industry, FDA has struggled with where to place international issues on the list. FDA has viewed it as a business issue rather than a health priority, but recognizes that the two areas ultimately intersect.

CTFA has asked the agency to take a more active approach in international harmonization, suggesting one person from the Office of Cosmetics & Colors be dedicated exclusively to international efforts.

With the release of the 1999 priorities list, Levitt vowed CFSAN would take a more "proactive" approach to international issues in place of the largely reactive actions of the past (⁷ (Also see "CFSAN's Levitt Vows "Proactive" International Approach" - HBW Insight, 1 Feb, 1999.)).

As a result, FDA has taken part in meetings on Latin American harmonization, as well as on the Cosmetics Harmonization and International Cooperation initiatives. As part of its goals for 2000, the agency said it would continue to support EU-U.S. bilateral meetings and CHIC. This spring, the agency will host a CHIC meeting in Washington, D.C.

Color additive lakes closed out the "B" list for 2000. The agency hopes to "make progress" on the listing of its March 4, 1996 proposed rule. FDA's proposed rule would permanently list color additive lakes and allow the use of abbreviated color additive names on cosmetics labels.