Regulatory Explainer: Understanding the Regulation of New Sunscreen Ingredients

Posted 19 March 2014 By Alexander Gaffney, RAC

For the last few years, the US Food and Drug Administration (FDA) has come under fire from advocates of new sunscreen ingredients who claim the agency has been dragging its feet at the expense of consumers.

As part of our ongoing series of Regulatory Explainers, we thought we would break this issue down to make it easier to understand.

What Kinds of Products Contain Sunscreen?

Sunscreen ingredients are in a huge number of consumer skin products. Pick up almost any tube of lip balm, in fact, and you're likely to find active sunscreen ingredients such as avobenzone, octinoxate, oxybenzone. Plenty of lotions also contain these ingredients as do-of course-sunscreen products intended for people spending time in the direct sun, such as at the beach.

How are these Ingredients Regulated by FDA?

Sunscreen ingredients are primarily regulated under what's known as a monograph, which is essentially a standard for active ingredients. If a monograph has been issued for a product, all a company has to do is show that it has met the standards of that monograph to be allowed on the market.

The monograph process allows companies to avoid other more rigorous regulatory pathways, such as the New Drug Approval (NDA) process for new ingredients, the Abbreviated New Drug Approval (ANDA) process for generic drugs, or the lengthy and rarely used Time-and-Extent Application (TEA) process for products that have long been on the market.

Because FDA regulates sunscreen ingredients as drugs, each active ingredient must be approved before it can be allowed on the market. The overwhelming majority-if not all-of these ingredients are regulated under a series of monographs which have been approved over the past several decades.

For example, FDA approved several final monographs for sunscreen ingredients in May 1999, bringing to a close a process that had started in August 1978. With the exception of some technical amendments made to the monographs in June 2003 and changes to labeling requirements, FDA has not approved any new sunscreen ingredients through the monograph process since 1999.

FDA's sunscreen monograph may be found in the Code of Federal Regulations (CFR) at 21 CFR 352.

Which Ingredients are Currently Allowed on the Market?

Twenty-four Ingredients are now regulated by FDA under its various final monographs.

Sunscreen Ingredients Regulated by OTC Monograph (21 CFR 352.10)

Aminobenzoic acid (PABA) up to 15%Avobenzone up to 3%
Cinoxate up to 3%Dioxybenzone up to 3%
Homosalate up to 15%Menthyl anthranilate up to 5%
Octocrylene up to 10%Octyl methoxycinnamate up to 7.5%
Octyl salicylate up to 5%Oxybenzone up to 6%
Padimate O up to 8%Phenylbenzimidazole sulfonic acid up to 4%
Sulisobenzone up to 10%Titanium dioxide up to 25%
Trolamine salicylate up to 12%Zinc oxide up to 25%
Ensulizole up to 4%Homosalate up to 15%
Meradimate up to 5%Octinoxate up to 7.5%
Octisalate up to 5%Octocrylene up to 10%
Oxybenzone up to 6%Padimate O up to 8%

Have any New Ingredients Attempted to Reach the Market?

Several have, all through the Time and Extent process. Let's explain the TEA process first.

TEA applications are meant to allow companies to bring technically-new ingredients to US consumers based on their profile of use in other countries.

For example, if a sunscreen ingredient had been in use for five years in the EU, a company could apply for approval in the US based on the product's use abroad, allowing it to bypass FDA's extensive (and expensive) clinical trial requirements, which generally call for at least two Phase III clinical trials to prove the safety and efficacy of the product. The underlying regulatory theory is that a product that is safe for consumers in one country is likely safe for the consumers of another.

TEA applications are regulated under 21 CFR 330.14, which explains the various standards the applications must meet in order to be considered.

For example, a drug subject to a TEA submission must have been on a market for a "material extent" and "for a material time," taken to mean at least five continuous years in the same country and in large quantities ("extent"). Some simple rundowns of the TEA process are also available on FDA's website.

What does the TEA Process Look Like?

TEA might save you costs on clinical trials, but it's not designed to be a shortcut. Sponsors of TEAs must undergo a five-part process, any part of which can experience lengthy delays:

  1. Sponsor must generate a TEA application, including information about the drug, the time and extent of its marketing, and its use.
  2. FDA must then determine if the drug is eligible under the monograph system. In essence: Would this drug be able to be used without the supervision of a healthcare professional by most people?
  3. The TEA submission is then opened to public comment, including comment from rival manufacturers and public interest groups.
  4. FDA determines whether the ingredient is generally regarded as safe and effective (GRASE), and thus eligible under the monograph system.
  5. FDA then proposes and later finalizes a regulation (rule) on adding the drug ingredient to the sunscreen monograph. In some cases, it also publishes an advanced notice of public rulemaking, which is a notice that it plans to issue a draft regulation in the future.

OK, So Which Sunscreen Ingredients Have Tried to Reach the Market via the TEA Process?

At least eight sunscreen ingredients have applied for FDA approval under the TEA process:

Ingredients Year Application Began Rulemaking Process
Amiloxate, enzacamene, and octyl triazone2003 (Amiloxate Delayed in 2014)
Bisoctrizole and bemotrizonol2005
Diethylhexyl butamido triazone2006 (Delayed in 2014)
Terephthalylidene dicamphor sulfonic acid (ecamsule)2008
Drometrizole Trisiloxane2010

As you can see, one of these ingredients has been under formal review for more than a decade, while three others have been sitting at the agency for between six, eight and nine years, respectively.

There Are a Lot of Sunscreen Ingredients on the Market Already. Why Does This Matter?

Advocates for the new sunscreen ingredients tend to cite four arguments when calling for FDA to approve these products.

The first is that the new ingredients have already been on the market for years-more than a decade in some cases-with no apparent issues, making their failure to obtain FDA approval all the more curious. The ingredients are available in Canada and Mexico, as well as parts of Europe, Asia and South America.

The second is argument is that the new ingredients are (purportedly) better. The combination of sunscreen ingredients offers wider spectrum protection against ultraviolet (UV) rays, which are the cause of sunburns and many skin cancers. They also reportedly allow for longer time periods of protection-a particular benefit for consumers who may be spending long periods of time in the sun and who might not remember to re-apply sunscreen every hour.

The third is that some of these ingredients are already approved in the US under more limited applications. L'Oreal's drug, ecamsule, is already approved for use in three products on the US market, having obtained approval under the New Drug Application (NDA) process. FDA approved one, L'Oreal's Anthelios SX, in 2006, touting its effectiveness against UVA and UVB radiation. The drug has been approved in Europe and Canada since 1993.

The fourth argument is one of regulatory certainty. If companies know that their competitors have been waiting for more than a decade to obtain approval for an ingredient, they argue, then companies will be reluctant to file their own applications since it will likely take so long to see a return on their initial investment. No new applications, no new or potentially better types of sunscreen.

What's FDA's Response to these Delays?

FDA has been relatively silent on the issue, but has made a number of public statements defending its actions.

In November 2013, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER) told House legislators that FDA is "more frustrated than the manufacturers are" about the delays, citing the difficult process of establishing new regulations to issue final monographs.

"They're backlogged and slow to get through," she added, saying that on average this process takes between six and eight years to complete.

And as reported by The Tan Sheet, in other cases FDA has found the company's TEA submissions lacking, finding the submitted data "insufficient to affirm the safety" of the products. A lack of acceptable data was also cited by experts consulted by The Wall Street Journalfor a May 2013 article.

Regulatory standards differ widely between countries, and what is acceptable to regulators in Europe or Canada is not always acceptable to US regulators. And as noted by some consumer watchdog groups, sunscreen ingredients that aren't effective can have dangerous implications for consumers, who may later develop skin cancer. Other ingredients can cause allergic reactions or other adverse reactions.

Delays to seek out more conclusive safety and efficacy data, in other words, aren't always a bad thing.

"FDA recognizes the public health importance of sunscreen use, and has prioritized its review of the safety and effectiveness of additional sunscreen ingredients, and is proceeding as quickly as practicable given available review resources and competing public health responsibilities," FDA spokeswoman Andrea Fischer told Focus. "FDA remains committed to making sunscreens containing additional ingredients available to consumers if sufficient data to establish that they are generally recognized as safe and effective for use in over-the-counter (OTC) sunscreens are provided."

What Have Manufacturers Been Doing in Response to these Delays?

In March 2013, manufacturers launched a new legislative-focused group known as the PASS Coalition, standing for Public Access to Sunscreens. The group said its aim is to bring together stakeholders-including FDA-to "Establish a framework for approval of the next generation of UV light active filters for over-the-counter (OTC) sunscreens."

"The current pre-market review process needs to be reformed to ensure timely review and add transparency and predictability," the group writes on its website.

The group noted that recent research indicated that as many as one in 10 people in the US will develop skin cancer in their lifetime, making access to more effective sunscreens all the more important.

The PASS Coalition is recommending that the TEA process be reformed and that FDA be given the resources it needs to process current and future applications.

What Have Legislators Been Doing in Response to these Delays?

Legislators have been slowly ratcheting up pressure on FDA for several years.

In 2013, several legislators pressed FDA on the issue at various times, such as Sen. Charles Schumer, Reps. John Dingell and Ed Whitfield and Sen. Diane Feinstein, as well as others.

In March 2014, legislators in the House (H.R.4250) and Senate (S.2141) released companion versions of legislation known as the Sunscreen Innovation Act (SIA).

The bills call for FDA to review all sunscreen ingredients that would be eligible under the TEA process through an expedited process. That process would see applications reviewed in a timeframe measuring months-not years. Even accounting for delays (such as FDA seeking additional data), most submissions would likely be able to receive approval within two years of submission.

The law calls for existing applications to be reviewed within 8 months, and new submissions to be reviewed within 11 months, reports FDA Law Blog.

An advisory committee would also review all drugs submitted through the sunscreen TEA pathway.

FDA would also be charged with developing testing and labeling requirements for sunscreens sold as an aerosol, and also charged to revisit whether sunscreen may be labeled with a sun protection factor (SPF) greater than the current limit of 50.

What Now?

FDA is currently preparing its own overhaul of the OTC drug monograph system, so it's possible that change will come even if the above legislation is never passed.

FDA's 25-26 March 2014 hearing on the "Past, Present and Future" of the OTC monograph system is set to explore how the current monograph system can be improved with an eye on making it faster, easier and more efficient. While that process may take a year or longer to bear fruit, by FDA's own admission, the system seems to be broken and in need of change.

Where can I Learn More about this Issue?

  • Read more about the rulemaking history for OTC sunscreen products here.
  • Read FDA's sunscreen monograph here.
  • Read FDA's Guidance on the TEA process here.
  • Read about the OTC drug monograph process here and here and here.
  • Read about FDA's new sunscreen labeling rule here and here.
  • Read up on all instances of Regulatory Focus specifically writing about sunscreen here, and every time our news editors mention the topic (such as in a link to another news story) here.

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Categories: US, FDA

Tags: How is Sunscreen Regulated?, FDA Regulation of Sunscreen, Regulation of Sunscreen, Regulatory Explainer, Sunscreen, Latest News

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