Guidance for Industry: Enforcement Policy OTC Sunscreen Drug Products Marketed Without an Approved Application

Name of Guidance:

Guidance for Industry: Enforcement Policy OTC Sunscreen Drug Products Marketed Without an Approved Application

Status of Guidance:

Draft guidance, final expected to be issued in 2011

Date of Guidance:

 June 2011

Names of Organizations Releasing the Guidance:

United States Department of Health and Human Services (HHS)
United States Food and Drug Administration (FDA)
Center for Drug Evaluation and Research (CDER)

Target Audience:

Manufacturers of over-the-counter (OTC) sunscreen drug products without an approved application.

Guidance Laws and Regulations Referenced in the Guidance:

21CFR 201.327, §201. §327(c)(3), §201.327(g), §201.327(l): FDA guidances pertaining to SPF labeling and testing requirements for OTC sunscreens.
21 CFR 352.10, 21CFR 352.20
21CFR 330.1: Guidance addressing GRASE drugs, ie, drugs generally recognized as safe and effective.
21CFR 310.545(a)(29)(ii): Guidance regarding active ingredients found in OTC drugs, including sunscreens.

Definitions:

Drug monograph: A description of a drug or class of drug that specifies their ingredients, directions for use, conditions of use, and contraindications.

GRASE: Acronym for Generally Recognized as Safe and Effective.

OTC: Over-the-counter. Here, OTC sunscreens are those sold directly to customers without a prescription.

SPF: Sun protection factor. A rating; for sunscreens from 2 to 50 plus, that indicates the extent of protection provided by a sunscreen.

UVA and UVB: Ultra-violet rays A and B, which are responsible for tanning, but also for sunburn, skin damage, or sometimes skin cancer.

Background:

Some over-the-counter (OTC)  sunscreens appear on the market without FDA application approval. Since there is no final description, or drug monograph, of this class of drug, the FDA has been unable to finalize guidances pertaining to these products. Concern over safety and effectiveness led the FDA to issue numerous publications to guide manufacturers by expressing its viewpoint. This draft guidance is the most recent publication on the topic and the final guidance, pending the drug monograph and other studies, should also be available in 2011. The main concerns regarding OTC sunscreens are testing and labeling requirements and proposed enforcement policy.

Summary:

Numerous Federal Register notices have be published by the FDA on the topic of OTC sunscreens. Key dates follow:

1978: Publication of notice of intent to address safety issues (SPF and GRASE).

1993: Safety issues addressed. A minimum SPF value of 2, as well as views on safe dosage forms are proposed.

1996-2000: Several active ingredients added to list of those eligible for inclusion in drug monograph.

2007: Safety and effectiveness discussed. Products containing insect repellent examined.

2011; Labeling and testing requirements modified (21CFR 201.327) for marketed sunscreens without application approval. SPF label upper limit of 50 plus required. Dosage forms eligible for inclusion in drug definition proposed.

Because a drug monograph has not yet been finalized for .OTC sunscreens, the FDA intends to use enforcement discretion until the monograph is finalized. Additional safety and efficacy data is being collected and will be incorporated in the final guidance expected to be issued in 2011. Other issues to be addressed in the final guidance include active ingredients, special warnings on sprays, and combination sunscreen and insect repellent.

Rationale:

 Manufacturers are currently marketing sunscreens without approved applications since there are no final requirements for testing and labeling of these products at this time. In addition, a final drug monograph of sunscreens is not yet completed. This guidance expresses the FDA’s expected finalized recommendations and intended enforcement approach. Manufaturers of OTC sunscreens should follow these recommendations while the final guidance is pending.

 Resulting Recommendations:

The following recommendations express the FDA’s intended enforcement policy pending finalization:

·        OTC sunscreens may be marketed without application approval if they are not potentially dangerous to use.

General safety issues concern:

o   Safety of active ingredients (21 CFR 352.10 and 352.20)

o   Appropriate claims in labeling (21CFR 201.327(c)(3) and (g) and 310.545(a)(29)(ii)

o   Adverse event reporting (21CFR 330.1) and adulteration.

o   Labeling and testing requirements (CFR 201.327)

·        In vitro broad spectrum testing must be done to test for protection across different UVA wavelengths (21CFR 201.327(i)).

·        OTC sunscreens claiming to have an SPF of over 50 should be marked 50+ or 50 plus,

·        Dosage forms differ in eligibility for inclusion in future drug definitions. Sprays.

should be labeled with special warnings to prevent inhalation, in compliance with 21CFR 201.327(e)(l)(ii).

Impact:

 This draft guidance serves to inform manufacturers of OTC sunscreens without approved applications of the FDA’s intended enforcement approach in regards to testing and labeling of these products. This will facilitate adherence to the final FDA guidance, expected to be issued in 2011.