Avon Advocates Amending Monograph For Bug Repellent/Sunscreen Combos

FDA should amend the sunscreen monograph to include a new subpart for combination insect repellent/sunscreen drug products and work with the Environmental Protection Agency to institute other minor changes, Avon states in May 23 comments.

Avon, which markets six products under the Skin So Soft Bug Guard brand, submitted its comments in response to FDA's request for information published in the Feb. 22 Federal Register (¹ (Also see "FDA Mulls Adding Insect Repellent Combinations To Sunscreen Monograph" - HBW Insight, 26 Feb, 2007.), p. 4).

While the company believes current FDA and EPA regulatory frameworks are sufficient to police combination insect repellent/sunscreen products, it does propose certain changes to "help ensure consistency in future labeling, facilitate cooperation between the two agencies, and assist FDA's compliance efforts."

In order to "avoid unnecessary repetition between the agencies' requirements and provide clarity for the consumer," the company recommends that FDA exempt combination insect repellent/sunscreen products from certain format requirements for OTC drug product labeling.

This would "obviate the requirement for the 'Drug Facts' format, and the required "warning" statements, to the extent that they are substantially equivalent to EPA's precautionary statement requirements."

Generally, Avon suggests that FDA defer to EPA's specific labeling requirements in situations where the two agencies have labeling inconsistencies, as "EPA's statements tend to be more tailored to the characteristics of the particular product."

For example, with respect to eye safety, FDA requires the statement: "When using this product keep out of eyes. Rinse with water to remove," Avon says.

Meanwhile, EPA requires much more specific statements, such as: "If in eyes: hold eye open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye."

The company also recommends that FDA defer to EPA's "signal word" because EPA's choice of signal word - either "Danger," "Warning" or "Caution" - is based on a toxicological review of the product and the relative risk it is determined to pose.

For instance, "Danger" denotes the most hazardous material while the least hazardous may bear the word "Caution" or no signal word at all.

In contrast, FDA requires the word "Warning" on all OTC drug products, which could lead to misunderstanding that the product is more hazardous than it actually is, according to Avon.

While FDA requires the signal word to appear on the back panel, EPA mandates its inclusion in various places on the label, including the front panel. This increased prominence "ensures increased protection for the consumer," Avon says.

An Inter-Agency System For Ensuring Compliance

The second change Avon proposes is the establishment of a system by which EPA provides FDA with copies of labels of registered insect repellents containing sunscreen.

The company explains that although it feels "primary regulatory oversight with respect to insect repellents containing sunscreen should remain with EPA, we believe it is important for FDA to easily monitor labels of these products for OTC drug compliance purposes."

Avon recommends that the agencies develop an inter-agency system in which a designated EPA liaison forwards the final label of the registered combination product to an FDA liaison.

The label exchange would come after the registration process is completed, and FDA review of the label would not be a condition of registration, Avon says.

Nevertheless, the scheme would allow FDA to conveniently monitor the labels of recently registered insect repellents containing sunscreen and allow it to exercise its OTC drug enforcement jurisdiction.

Avon says there is "ample precedent" for such a system, as FDA has set up a similar system with the Securities and Exchange Commission that allows the agency to share information with SEC and SEC to seek FDA's input "where appropriate."

Lastly, the company recommends that EPA work with FDA to create a new chapter in its Label Review Manual to address both agencies' regulatory requirements associated with these products.

According to Avon, insect repellent manufacturers would benefit from EPA guidance regarding joint regulation, as some of the manufacturers may have previously marketed only insect repellents and may not be familiar with FDA's requirements for those that contain sunscreen.

The chapter would ensure that manufacturers of insect repellent/sunscreen combination products are aware of their obligation to comply with FDA's requirements under the sunscreen monograph, the firm says.

For example, the chapter could alert applicants that FDA requires products containing sunscreen to include a list of inactive ingredients and that the absence of such information can lead to FDA enforcement action, Avon notes.

FDA's Concern Is Ingredient-Specific, Avon Says

When addressing the questions FDA posed in its Federal Register notice, Avon points out that the agency's focus is on insect repellent/sunscreen combination products that contain DEET (N,N-diethyl-m-toluamide).

Avon maintains that any concerns associated with the use of DEET "are ingredient-specific and thus do not apply generally to all insect repellents containing sunscreen," such as the firm's Skin So Soft Bug Guard line, which features the insect repellent IR3535 .

For instance, while DEET is not supposed to be applied to the ears or to children's hands, IR3535 carries no such restrictions, according to Avon.

The firm also addresses FDA's concerns about different use instructions for the sunscreen and insect repellent components.

The agency had noted that instructions for sunscreens to be "applied liberally" are incompatible with products containing a repellent such as DEET, which are to be "applied sparingly." The conflict could lead to over-application of the repellent or under-application of the sunscreen, FDA suggested.

Avon maintains that while "frequency of application" may be a point of inconsistency between EPA and FDA labeling requirements for combination products employing certain insect repellents, "this is not true for products containing IR3535," Avon says.

The company explains that its labels - which have been approved and accepted by FDA - include statements such as "Apply liberally and evenly before sun and insect exposure" along with the statements "For continued protection from insects re-apply after [a certain number of] hours" and "Do not exceed [a certain number of] applications per day."

"These directions do not encourage 'over-application of the repellent' nor 'under-application of the sunscreen,'" Avon says.

With regard to FDA's concerns that sunscreen ingredients and insect repellent ingredients could diminish one another's efficacy when combined, Avon maintains that any lowered effectiveness would be observed during formulation and the efficacy testing process.

"The formulating company would have the option to adjust the final formulation accordingly to compensate for any loss in effectiveness," the firm says.

It notes that the manufacturer must either adjust the concentration of the sunscreen ingredients to compensate for the reduced SPF or report the lower SPF on the label.

"Simply put, the stated SPF on the product label should accurately reflect the SPF regardless of any effect of the insect repellent active ingredient," Avon says, stressing that premarket testing should always be conducted to establish the actual SPF level.

This would be true of any other ingredient in the sunscreen formulation, according to Avon.

"It is unclear as to why EPA's questions are centered primarily on combination insect repellent/sunscreen drug products," the company says.

Avon highlights the benefit of combination products by pointing out that if a consumer applies separate insect repellent and sunscreen products, he or she has less assurance that the resultant SPF protection and duration of insect repellent remains the same as indicated on the labels.

- Melina Vissat ([email protected])