Comments on Proposed FDA Regulations For Sunscreen

It should be noted that all the current hubbub regarding the FDA Sunscreen guidelines are only proposed regulations that are scheduled to go into place the summer of 2012. Final regulations are still in the making.

The FDA’s new regulations have been developed to help consumers better understand what they are purchasing when they buy a bottle of sunscreen. Sunscreen manufacturers have been overstating claims of the effectiveness for their product. Let’s take a look at those claims one by one:

Claim #1: High SPF, such as an SPF of 100 for example, provides a lot more sun protective than say SPF 30. It certainly captures the consumer’s eye but, high SPF ratings are just a marketing ploy. The difference between an SPF of 100 (99% UV block) and that of SPF 30 (98% UV Block) is only 1%. The FDA proposes to limit sunscreen manufacturers to an SPF of 50… using 50 SPF verses 30 as the maximum SPF rating is possibly a compromise by the FDA for the manufacturers benefit since the difference in sun protection is negligible.

In the past, SPF has only been a measure of UVB (also called the sunburn ray) radiation and did not take into account the importance of UVA protection. Sunscreens will now have to pass FDA’s broad spectrum test procedure, which measures a product’s UVA protection relative to its UVB protection. It was not clear to me how they plan to test and rate the UVA penetration but, if the sunscreen does pass, the manufacture will be able to use a Broad Spectrum SPF rating indicating the amount or magnitude of overall protection.

Claim #2: Using sunscreen prevents skin cancer and premature aging caused by sun damage? Scientist are considering the fact that geographical areas using more sunscreen have shown an increased incidence of skin cancer.

The FDA Proposed wording for sunscreen manufacturers: Non-Broad Spectrum sunscreens and Broad Spectrum sunscreens with SPF values between 2 and 14 can only claim to help prevent sunburn. Only Broad Spectrum sunscreens (sunscreens that protect against UVA and UVB radiation) 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 protective measures.

That said, it should be noted that sunscreen, no matter how high the SPF rating or how broad the spectrum, will always allow damaging UV radiation to harm the skin if you stay out for a prolonged period of time. The amount of sun damage varies with an individual’s skin type, latitude, altitude, etc., but if you plan to be out for hours, you are going to get sun damage! Sunscreen is an important tool for sun safety but it is one of the last precautions to depend on. Sun protective clothing, sun hat, sungloves, etc. provide far more reliable sun protection than sunscreen.

Claim #3: “Waterproof”, “sweatproof” or “sunblock” claims. Sunscreen manufacturers cannot label their products as “waterproof” or “sweatproof,” or identify their products as “sunblocks,” because such 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 without submitting data to support these claims and obtaining FDA approval.

Water resistance claims on the front label will need to indicate whether the sunscreen remains effective for 40 minutes or 80 minutes.

The new regulations also mandate sunscreen manufacturers to include “Drug Fact” information on the back and/or side of the sunscreen container that list warnings and other important information for the consumer.

After 30 years in the making I am delighted to see something coming through the FDA to protect the consumer. My concerns lie in how the FDA will rate UVA penetration and that most people view sunscreen as their primary means of sun protection. If the FDA’s UVA rating system is not strict enough we will get what we have gotten in the past and that is an inaccurate measurement of a sunscreens ability to protect the skin. And, if people do not use sensible sun protective measures, such as finding shade or wearing sun protective clothing and hats, and rely on sunscreen only to keep their skin healthy, they will most possibly pay the price in later years.


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