Monthly Archive for: ‘June, 2011’

New FDA Labeling Rules Allow Sunscreens to Claims of Reduced Risk of Skin Cancer and Early Skin Aging

Sunscreen products now may be labeled with new information stating that they reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn, , when used with other sun protection measures, under a new FDA regulation effective June 14, 2011.

Products that pass the FDA’s test for protection against both UVA and UVB rays now may be labeled as “Broad Spectrum.”  Under the new labeling, sunscreens labeled as both Broad Spectrum and SPF 15 (or higher), if used regularly, as directed, and in combination with other sun protection measures will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging.

However, products that have SPF values between 2 and 14, while they may be labeled as Broad Spectrum if they pass the required test, cannot state that they reduce the risk of skin cancer and early skin aging, when used as directed. Only products labeled Broad Spectrum and with SPF values of 15 or higher may make that statement.

The new regulations will become effective for most manufacturers in one year. Manufacturers with annual sales less than $25,000 have two years to comply.

The specific requirements of the final rule include:

  • Broad Spectrum designation. Sunscreens that pass FDA’s broad spectrum test procedure, which measures a product’s UVA protection relative to its UVB protection, may be labeled as “Broad Spectrum SPF [value]” on the front label.
  • Use claims. Only Broad Spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non-Broad Spectrum sunscreens and Broad Spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn.
  • “Waterproof, “sweatproof” or “sunblock” claims. Manufacturers cannot label sunscreens as “waterproof” or “sweatproof,” or identify their products as “sunblocks,” because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection for more than 2 hours without reapplication or to provide protection immediately after application (for example– “instant protection”) without submitting data to support these claims and obtaining FDA approval.
  • Water resistance claims. Water resistance claims on the front label must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating.
  • Drug Facts. All sunscreens must include standard “Drug Facts” information on the back and/or side of the container.

In addition to the final rule for sunscreen labeling, the FDA released three additional regulatory documents — a Proposed Rule, an Advance Notice of Proposed Rulemaking (ANPR) for Dosage Forms, and a Draft Enforcement Guidance for Industry.

  • The proposed rule would limit the maximum SPF value on sunscreen labels to “50 +”, because, FDA says,  there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50.
  • The ANPR will allow the public a period of time to submit requested data addressing the effectiveness and the safety of sunscreen sprays and to comment on possible directions and warnings for sprays that the FDA may pursue in the future, among other issues regarding dosage forms for sunscreens.
  • The Draft Enforcement Guidance for Industry outlines information to help sunscreen product manufacturers understand how to label and test their products in light of the new final rule and other regulatory initiatives.

FTC Finalizes Agreement with Oreck Settling Complaint Concerning Deceptive Health Claims

The FTC has finalized the order settling charges with Vacuum cleaner and air cleaner marketer made false and unproven claims that two of its Halo vacuum and the ProShield Plus air cleaner can reduce the risk of flu and other illnesses, and eliminate virtually all common germs and allergens. As part of the settlement, Oreck agreed to pay a $750,000 fine to the FTC.

The Halo is a $599.95 upright vacuum with a light chamber that generates ultraviolet light onto the floor while vacuuming. The ProShield Plus is a $399.95 portable air cleaner that filters air particles using an electrostatic charge.

According to the FTC complaint, Oreck used infomercials, traditional TV and print ads, in-store displays and online ads to promote the products, most of which highlighted germ-killing and illness-prevention claims. The FTC charged Oreck Corporation with making these allegedly false and deceptive claims about the two products, including:

The Halo and the ProShield Plus prevent or substantially reduce the risk of flu.

The Halo and the ProShield Plus prevent or substantially reduce the risk of other illnesses or ailments caused by bacteria, viruses, molds, and allergens – such as the common cold, asthma, and allergy symptoms.

The Halo eliminates all or almost all common germs and allergens found on the floors in users’ homes, and is scientifically proven to do so.

The Halo’s ultraviolet light is effective against germs, bacteria, dust mites, mold, and viruses embedded in carpets.

The ProShield Plus eliminates all or almost all airborne particles from a typical household room under normal living conditions, and is scientifically proven to do so.

The complaint also alleges that Oreck provided deceptive advertisements to its franchised stores for their use in marketing the Halo and the ProShield Plus. By doing so, the FTC said, Oreck provided the means and instrumentalities to its distributors to deceive consumers.

Under the terms of the administrative settlement, Oreck is barred from making any of the allegedly deceptive claims in the complaint for any vacuum cleaner or any air cleaning product unless it has competent and reliable scientific evidence to support them. The company also is prohibited from making any claims about a product’s comparative health benefits without competent and reliable scientific evidence, and from misrepresenting the results of any scientific test, study, or research.

More information on the case is available in the original complaint, settlement agreement and print promotional materials exhibits.