The long and winding road to sunscreen regulation reform in the US may have gotten shorter, but we’re not home just yet. The journey started 42 years ago in 1972 when the FDA began reviewing over-the-counter products not covered by a New Drug Application (NDA). The FDA established review panels to evaluate OTC products/drugs and began developing monographs for each category of drug product. If an OTC drug meets the criteria established in a monograph, it is considered generally recognized as safe and effective (GRASE) and does not need independent pre-market approval. In comparison, many sunscreen ingredients in markets overseas are not approved for use in the US. If this trend continues, the US will lag far behind the rest of the world in providing effective protection from the sun.
There have been many stops on the journey toward regulation. The existing OTC drug monographs are codified in 21 C.F.R. Part 330. Although several versions of a final monograph for sunscreen products have been developed, no final regulations have been implemented. In August 1978, the first regulation, the Advanced Notice of Proposed Rulemaking (ANPR) was issued and a listing of 21 allowed Category I UV Filters was included. It was followed in 1993 by a Tentative Final Monograph. In August 2007, the Proposed Final Rule came out and, finally, in June 2011, the Final Rule was released and later implemented in 2013.
Unfortunately, this Final Rule only addresses three conditions regarding a product’s ability to be considered a sunscreen and make the claim that “sunscreens reduce the risk of skin cancer and early skin aging when used as directed.” These conditions are:
- The product must pass a broad spectrum test;
- It must have a minimum of SPF 15; and
- It must comply with the modified Principal Display Panel (PDP) Drug Facts.
- A decision on the TEA (Time and Extent Application) Ingredients. Since 2002, only two of the eight applications have received notices—one as recently as last month—for additional information. None were adopted.
- The Proposed Rule to decide on the current practice of labeling sunscreen products with more than SPF 50.
- The ANPR of deciding on the current practice of marketing spray products.
The rule does not address a host of other shortcomings including a ruling on the use of nanoparticles, the recent controversies surrounding the safety of a few Category I ingredients, natural sunscreen claims and other testing issues.
Settling all these issues seemed unlikely unless more drastic action was taken. This led to a group of scientists and dermatologists, a number of major manufacturers with deep pockets, and some health organizations to retain a powerful lobby group in Washington, DC to take our case to Congress. The PASS (Public Access to Sunscreens) Coalition has managed, in a little more than a year, to lobby members of Congress to enact the first legislation in recent memory that specifically deals with sunscreens.1
On March 13, 2014, Senate Bill S-2141 and House Bill H.R. 4250 were introduced by Senators Reed (RI) and Isakson (GA) in the Senate and Congressmen Whitfield (KY-1) and Dingell (MI-12) in the House. The Sunscreen Innovation Act was introduced on a bipartisan and bicameral basis and currently has 12 co-sponsors in the Senate, including Reed (RI), Ayotte (NH), Brown (OH), Carper (DE), Coons (DE), Isakson (GA), Kirk (IL), Landrieu (LA), McConnell (KY), Portman (OH), Roberts (KS) and Warren (MA). It also has 30 co-sponsors in the House. They are: Barr (KY-6), Barrow (GA-12), Bishop (NY-1), Blackburn (TN-7), Carney (DE), Crenshaw (FL-4), Dent (PA-15), Diaz-Balart (FL-25), Dingell (MI-12), Ellmers (NC-2), Farr (CA-20), Forbes (VA-4), Graves (GA-14), Griffin (AR-2), Guthrie (KY-2), Johnson (OH-6), Kingston (GA-1), Lance (NJ-7), Lankford (OK-5), Latta (OH-5), Maloney (NY-12), Matheson (UT-4), Murphy (PA-18), Noem (SD), Perlmutter (CO-7), Rogers (KY-5), Rooney (FL-17), Ross (FL-15), Stivers (OH-15), Tiberi (OH-12) and Whitfield (KY-1).
Recently, the House Energy and Commerce Health subcommittee held a hearing attended by Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research. Dr. Woodcock acknowledged that the problem with sunscreens is a “microcosm” of larger problems with agency regulations and concluded that the FDA would like to overhaul the whole process behind those regulations, which are known as OTC drug monographs. On May 29, the House Appropriations Committee released a bill that included strong language on the current state of the eight pending TEA applications. The Committee stated that immediate action should be a priority and that Congress is “extremely concerned” that another year has passed without the FDA completing its review of the pending Time and Extent Applications (TEAs) and the OTC Monograph rulemakings on sunscreens.
The report language continued “Committee directs the FDA to complete its review by 2014 and to work expeditiously on completing the OTC monograph rulemakings.”2
Is this for real? Does Congress have the power to force the FDA to finalize the OTC Sunscreen Monograph by the end of 2014? Perhaps it is wishful thinking but, clearly, we finally have a mechanism to forge ahead and assure that legislation is issued that will move this process to a speedier conclusion.
As regulations are debated, delayed and introduced piecemeal in the US, skin cancer is on the rise. Skin cancer is the most common form of cancer diagnosed in the US. Each year there are more new cases of skin cancer—including melanoma—than the combined incidences of breast cancer, prostate cancer, lung cancer and colon cancer. On average, one person dies every hour from melanoma, the deadliest of the skin cancers, due to its ability to move quickly and spread to distant organs in the body. Melanoma rates are rising dramatically across demographics, too. During the past 40 years, melanoma rates have increased 800% among young women and 400% among young men.3 The Sunscreen Innovation Act has received extensive media attention.4
In late May, the FDA announced stricter rules on tanning beds. Too little too late again! With nearly 30 million Americans exposing themselves to the harmful rays of tanning salons each year—two million of them teenagers—only eight states banned indoor tanning for minors under 18. All the FDA did was to re-classify the risk of sunlamp products at tanning salons from low-risk items like adhesive bandages to moderate-risk ones such as dialysis equipment and several types of catheters. It also required manufacturers to put a black-box warning on the devices stating that they should not be used by anyone under the age of 18, but stopped short of banning their use altogether by minors.5
In May, several organizations held meetings and clinics during the Skin Cancer Awareness month. It has also become a tradition that both Consumer Reports (CR) and the Environmental Working Group (EWG) issue their annual reports on sunscreens at this time. Both reports are diametrically opposed to one another and offer contradictory conclusions. Whereas CR actually tests two dozen or so sunscreen products, the EWG only examines the labels of several hundred products. Consumer Reports*6 recommended seven sunscreen products:
- Banana Boat Ultra Defense Max Skin Protect SPF 110 (overall score of 99/100);
- BullFrog WaterArmor Sport InstaCool SPF 50+ (95/100);
- Neutrogena Ultimate Sport SPF 70+ (93/100);
- Up & Up (Target) Sport SPF 50 (90/100);
- Well at Walgreens Sport SPF 50 (87/100);
- Coppertone Water Babies SPF 50 (81/100); and
- Equate (Walmart) Ultra Protection SPF 50 (80/100).
In early June a well-attended Antioxidant Symposium organized by the New York Chapter of the Society of Cosmetic Chemists was held in New York City and addressed a number of issues dealing with protection from the sun and the elements (see p. 46 for more coverage). The highlight of the symposium, for me, was Dr. Krutmann’s presentation on the dangers of IR radiation and the need for protection from those wavelengths as well.8 In addition, Dr. Olga Dueva-Koganov shared with me her latest publication on in-vitro evaluation of topical products against infrared radiation.9
It has been a long road to better protection. With relatively few innovations for better sun care protection being introduced in the US, with conflicting regulations and the lack of definitive legislation, we will continue to lag behind other nations in introducing more effective products and protocols to protect consumers from the rising incidence of skin cancer. Further delay is measured in lives lost to the harmful effects of the sun. Forty-two years is a long enough time on the road to the Final Monograph. I trust that 2015 will usher in a new era of sun protection in the US.
- The PASS Coalition is a multi-stakeholder coalition of public health organizations, dermatologists, sunscreen ingredient companies, and concerned citizens who will work collaboratively with the FDA, the White House and Congress to establish a timely and transparent framework for approval of the next generation of UV active filters for OTC sunscreens, www.passcoalition.com
- See for example, The New York Times, May 30, 2014 “New, better sunscreens could be coming,” by Alexandra Sifferlin. Also, The Huffington Post, May 9, 2014, “It’s time for the US to catch up on Melanoma Prevention” by Wendy Selig.
- “Increasing incidence of Melanoma among young adults,” Reed, Kurtis et al, Mayo Clinic Proceedings, Vol 87, issue 4, pp328-334 (April 2012).
- www.fda.gov/radiation-emitting products/tanning/default (5/29/2014)
- www.comsumerreports.org./sunscreens/May 2014
- C. Calles, M. Schneider, F.Macaluso, T. Benesova, J. Krutmann and P. Schroeder, J. Invest. Dermat. (2010), 130, 1524-36.
- O. Dueva-Koganov, A. Duev, R.Turner, S. Micceri, H & PC Today, Vol 9, No 2, March/April 2014 pp 37-43.
Alpha Research & Development Ltd
Dr. Nadim Shaath is the president of Alpha Research & Development, Ltd. in White Plains, NY. He has over 30 years of experience as chairman of the chemistry department at SUNY-Purchase and the CEO of Kato Worldwide. Recently he formed a consulting company serving the cosmetic industry called ShaathMeadows Corporation (SMC) with laboratories in New York, New Jersey, Texas, Florida and Egypt.