Category Archives: Law

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.

Healthcare Powers of Attorney

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New HITECH Requirements for Reimbursement Eligibility

 On July 13, Secretary of HHS Kathleen Sebelius announced final rules under the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009.  HITECH was part of the stimulus bill, also known as the Recovery and Reinvestment Act of 2009 (ARRA).    

 The new rules came from different agencies within HHS.  In its first wave of this change, CMS issued rules setting minimum requirements for the “meaningful use” of electronic health records (EHR) technology.  Healthcare providers will be asked to meet a core group of 25 requirements (23 for hospitals) that HHS says will focus on the quality, safety and efficiency of care, engage patients and their families in care, and promote the security of electronically stored personal health information.  In addition to these, providers must select from a menu of additional requirements they will also commit to meeting in order to qualify for incentive payments.  More criteria for demonstrating meaningful use would phase in as EHR technology becomes more robust.  

 The government will also provide over $27 billion in financial incentives for provider compliance over the next 10 years.  Providers can begin registering for the incentive program in January 2011.  A physician could receive up to $44,000 from Medicare and $63,750 from Medicaid for switching to a certified EHR system and implementing the minimum requirements.  On the other hand, providers failing to meet these standards by 2015 could see their reimbursements for professional services “adjusted,” presumably downward.  

 To complement the CMS rules, the Office of the National Coordinator for Health Information Technology (ONC) also issued rules setting standards and a basic certification program for EHR software programs – to ensure that the software a provider buys from an approved provider will meet the minimum compliance requirements.  The agency expects certified software to become available in late 2010.