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.

Banaba and Diabetes

While traveling outside the US recently, a kindly woman encouraged me to investigate a natural product she said was a “miracle worker” for people managing diabetes as a chronic condition.  I forgot all about it for a while, but recently I was reading a supplement label and noticed that name again — Banaba extract.  Also known by a host of other names, such as Corosolic acid, Queen’s Crape Myrtle, Pride-of-India, and perhaps more formally as Lagerstroemia speciosa, this extract is being touted by many diabetes sufferers as a good naturopathic option.  According to other online sources, Banaba extract may also be helpful in weight loss.

Read more from WebMD about Banaba extract.

If you make or sell natural therapies, contact us learn more about how to label and market your products in compliance with federal rules and guidelines.

Photo from Dave’s Garden.

Baxam Law Group, LLC;  www.baxamlaw.com

A Billion Dollar Plan to Reduce Hospital Errors, Infections and Repeat Admissions

Today, the Department of Health and Human Services quietly hosted (if that’s possible) a conference call to unveil its new Partnership for Patients initiative.  This initiative promised $1B in cash to hospitals, who eagerly participated in the call.  HHS says the purpose of this initiative is to find ways to reduce hospital infections and medication errors, and to prevent repeat admission of patients caused by lack of continuity in their care after they are discharged from the hospital environment.

According to HHS Secretary Kathleen Sebelius, “Americans go the hospital to get well, but millions of patients are injured because of preventable complications and accidents.”  On this basis, the Partnership for Patients is poised to spend $500M to fund research on best practices and model systems that reduce the occurrence of hospital-acquired infections and hospital errors by 40% by 2013. 

The initiative will also provide $500M for the Community-Based Care Transitions Program.  Hospitals are expected to use this money to develop ways in which patients can transition from a hospital to other patient care settings in ways that reduce the risk of readmission.  The goal is a 20% reduction in the number of patient readmissions by 2013.

Pragmatic hospital administrators who may see this initiative as an oasis of encouragement in the increasingly arid healthcare environment, but they might not have much choice but to do so.  What will probably happen somewhere down the road is that hospitals which cannot meet the standards for reduced errors will have to worry about the risk of cuts to their federal healthcare reimbursements.


Read today’s press release here.

Baxam Law Group serves entrepreneurs in healthcare.  Visit us at www.baxamlaw.com.

Dear Doctor Letter – risk evaluation & m

Dear Doctor Letter – risk evaluation & mitigation strategy for serious adverse effects from melanoma drug Yervoy is here: http://ow.ly/4uMMn

FDA Forum On Clinical Trial Design For Small Companies

Of the 18 new drug and biologics molecules approved in 2010, about half seemed to have been developed by small companies. The Center for Drug Evaluation and Research (CDER) just announced an upcoming forum on designing clinical trials.  This session is specifically for small businesses who want to learn more about how to plan and execute trials so they will generate data that meets FDA‘s review standards.

The meeting will be held on April 21, 2011 from 9:00 a.m. to 4:45 p.m. at the FDA White Oak Campus in Silver Spring, MD, just outside Washington, D.C.

According to CDER, topics to be covered include:

– Clinical trial design – the phased approach and the staged approach

– FDA’s Bioresearch Monitoring (BIMO) Inspection Program

– Challenges to conducting clinical research in the 21st century

– Practical concerns of electronic source documentation

– Different types of pharmacokinetic studies conducted during drug development

– Importance of bioequivalence studies

– Strategic Quality for Clinical Trials

– FDA inspection process

There is no fee to register for this meeting, and there are limited seats available.

Register, and download the agenda and presentation slides here.

Baxam Law Group, LLC advises startups and small business clients in intellectual property, regulatory and commercial law.

Pfizer Takes Supplements

Pfizer®, that pharmaceutical behemoth of the late 20th century, announced today it is buying the consumer products business of Ferrosan, a Danish supplement maker.  The deal price was not disclosed, but according to Yahoo Finance, Ferrosan said its 2010 earnings were about $55 million.  That is small pickings for a company of Pfizer’s size, but it is yet another trickle in the shifting tides of big pharma’s business focus.  

Truly novel blockbuster drugs are few these days.  One could speculate ad nauseum on the reasons for this, but one possible cause is that the companies who invest money in bringing drugs to market don’t want to risk big money on unproven chemical entities and metabolic pathways that might also be a challenge to cautious regulatory reviewers like those at the FDA.  The results of this very conservative approach from the industry (and from the government)are drugs that for the most part improve upon or modify some known molecular structure or sequence that has shown some success in the past.  It is good business investment for the drug companies, but not so much for the consumers who need “disease preventers” instead of palliative treatments, and for those who are already sick and need a new therapeutic approach instead of a variation of the tried and true.

There is a new wave coming, and in my opinion big cures will be coming from natural products and botanicals in the early part of this century, so this is a good move on Pfizer’s part.  It’s good for consumers too, because big drug companies have the cash to do the studies that would support approval of natural products and botanical therapies, even by the most conservative of regulatory systems.  Let’s hope we see more moves like this. 

Read Pfizer’s press release

Other new product prototypes to watch include Dendreon’s Provenge® immunotherapy treatment for advanced prostate cancer.

The Right to Complain – Medicare/Medicaid Rules Require More Notice

Today, the Centers for Medicare & Medicaid Services (CMS) released proposed new regulations that would expand the scope of notice that healthcare facilities are required to provide when they treat patients who are Medicare or Medicaid beneficiaries. 

As the law now stands, only hospitals where Medicare/Medicaid patients are treated as inpatients are required to let the patients know they can complain to a Quality Improvement Organization (QIO) if they take issue with the care provided to them in those facilities.  Patients might, for example, receive this notice as one of the forms they or their representatives must read and sign at the time of hospital admission.

The proposed CMS Rule requires that healthcare facilities which are not hospitals must also give patients the same notice of the right to complain.  This change would affect healthcare facilities such as ambulatory surgery centers, home health agencies, rehab facilities, hospices, long-term care facilities, physical/speech therapy centers, portable X-ray service providers and rural clinics.  Dialysis centers are exempt from this requirement.

QIOs are private organizations with doctors and other health care professionals on staff to review medical care, investigate complaints about the quality of care and implement improvements in the overall quality of care. There is at least one QIO located in every state.   The most recent listing of organizations that function as QIOs is here.

 The theory behind the new rule is that informing patients about their right to complain, not just about hospital care but about home health agencies or other forms of outpatient care as well will give the QIOs more insight into the performance of all these players in the managed care system.  In return, this should lead to better patient care and, in theory, reduce costs and eliminate waste in the Medicare/Medicaid system.  However, the  requirement to document that notice has been given might also increase the paperwork burden on small healthcare providers and perhaps expose them to cost-cutting in reimbursements that may not be justified.

The proposed rule is here

CMS is interested to know whether notice should be given after treatment as well as before treatment.  Comments from the public will be accepted until April 3, 2011.

Visit us at www.baxamlaw.com

FDA just announced it will hold an open

FDA just announced it will hold an open public meeting on food additives. Details to follow..

The Senate passed the food safety bill t

The Senate passed the food safety bill today with a bipartisan vote of 73-25. http://ow.ly/3hJ8k

Senate just deferred the final vote on t

Senate just deferred the final vote on the Food Safety Amendments bill to tomorrow.