Tag Archives: labeling

FDA Issues New Rules for Sunscreen Labels

Today the U.S. Food and Drug Administration (FDA) issued new rules for labeling sunscreen products.  Just in time for next year’s peak summer season (the rules take effect in 2012), the new regulations and guidance may help demystify the many labels consumers must wade through while browsing the drugstore aisles for protection against sun damage.  According to Dr. Lydia Velazquez of FDA, “We want consumers to understand that not all sunscreens are created equal.”

SPF is the ability of a sunscreen to block UVB rays, which cause sunburns.  The SPF number that has been used on sunscreen packaging gives no indication of how well a product protects the skin from UVA rays which, like UVB rays, can damage the skin, cause wrinkles and other signs of skin aging, and can also contribute to the development of skin cancers (watch the FDA video here).  The SPF number also does not indicate how long a person who uses the product can be exposed to sunlight before developing sunburn.   

Typically, a product marked SPF 15 will generally block about 94 percent of UVB rays, SPF 30 will block about 97 percent, and SPF 50 will provide about 98 percent blockage.

The new rule sets testing standards for what are called broad spectrum protection products – those that sufficiently block both UVA and UVB rays.  Sunscreens that meet these standards and receive a SPF rating of 15 or higher can be labeled with a statement that use of the product may reduce the risks of skin cancer and signs of early skin aging if used as directed and in combination with other sun protection measures.

FDA believes SPF values above 50 cannot be verified with scientific accuracy, and even then they may not necessarily offer adequate protection against UVA rays.  Accordingly, the agency also issued a proposed rule today that, if finalized in its current form, would ban the use of SPF designations above 50.   

Sunscreens not labeled as “Broad Spectrum,” or which have SPF values between 2 and 14, will now have to labeled with a warning that the product has not been shown to help prevent skin cancer or early skin aging.

Some of the now familiar terms used for sun care products, such as “sunblock,” “waterproof” and “sweat proof” must also now be removed from the labeling.  However, products can be labeled as water-resistant under certain conditions.

Large companies will have one year from the effective date of the Sunscreen Rule to change the sunscreen-related labeling on their products, while small companies will have two years to implement the changes.

For more information about labeling of consumer products, contact Baxam Law Group.

FDA To Further Study Standardized Risk/Benefit Labeling for Drugs

The Patient Protection and Affordable Care Act requires the Food and Drug Administration (FDA) to determine whether adding quantitative summaries of the risks and benefits of a prescription drug medication in a standardized format would help healthcare providers and consumers make better decisions about using the drug.  For the better part of the last decade, FDA has been discussing whether the types of information now provided are sufficient to advise these decisions.  Currently, a patient package insert (PPI) is required for some classes of drugs, or if there is a risk evaluation and mitigation strategy (REMS) in place for a high-risk drug; otherwise it is voluntarily submitted by manufacturers for other products.  A medication guide is usually required to be distributed with the drug if there is a REMS in place.

While the PPI and the Medication Guide are often required to be distributed, consumers may also be given consumer medication information (CMI). CMI is developed by drug manufacturers according to general guidelines provided by FDA, but is not subject to the same distribution requirements or oversight when used in association with products.

For most of the last decade, FDA has been evaluating the effectiveness of these types of written prescription drug information, and the agency has held several public meanings to discuss the matter with the industry.  Among the issues being looked at is the report that most patients prefer written information rather than numerical data; and numbers, percentages and statistics might be difficult for the consumer to understand unless they are presented in a simple, straightforward organization.  Patients most prefer verbal communication about a drug’s risks and benefits, but relying on this as a primary means of communication could increase the risk of inaccurate medication compliance. 

At the last meeting in 2009, FDA concluded that there are too many forms of written patient information, and that more study is needed to come up with a user-friendly format that would be sufficiently educational to the patient.  The healthcare reform statute supports this conclusion. Section 3507 of the statute directs FDA to continue studying whether providing quantitative summaries of the risks and benefits of each prescription drug in a standard format would be helpful to the process of making individual healthcare decisions.

Baxam Law Group, LLC