The FDA’s Updates for Sunscreen Products & the Sunscreen Innovation Act

BottleTubeSunscreenIn 2002, FDA first issued regulations on providing the process – The Time and Extent Application (TEA), to create a new Over the Counter (OTC) drug monograph, or amend an existing monograph that an active ingredient or condition is Generally Recognized as Safe and Effective (GRASE). The steps are two fold:

  • First, the drug must be determined to be eligible
  • Second, the drug must be determined to be GRASE

The Sunscreen Innovation Act (SIA) enacted in 2014, amended the FDC Act to provide specific deadlines for FDA’s TEAs for sunscreen active ingredients. In addition to these deadlines, the Sunscreen Innovation Act also required that the FDA publish Draft Guidelines on the implementation and compliance of approving new sunscreens. A few days before the deadline in November 2015, drafts were issued for the following guidelines for sunscreens.

  • Format of submissions by the sponsor to support GRASE Status – Evidence of safety and efficacy that the sponsor has submitted must be publicly available, and not marked as confidential.
  • Withdrawal of a Sunscreen TEA – The draft describes the consequences of withdrawal in various stages of the Sunscreen Innovation Act FDA will consider a TEA withdrawn if a sponsor fails to respond within 90 days for a request for a data or update by the FDA.
  • Requesting an Advisory committee review – This guidance clarifies what conditions may merit an advisory committee review and the process that FDA uses to warrant such a review. Importantly, there is a limit in the number of advisory committee meetings that the FDA must convene per sunscreen TEA per year set by the Sunscreen Innovation Act.
  • Safety and Effectiveness data to determine whether a sunscreen active ingredient is GRASE – This guidance outlines the various studies that may be needed to support safety and effectiveness of sunscreens. With respect to safety, the FDA wishes to address dermal irritation tests, photo-safety (exposure to sun) reactions, and adverse event – and skin absorption studies. Where there are more serious concerns (e.g. carcinogenicity), then additional data (animal) may be required. Lastly, there is a potential for pediatric specific studies depending on the characteristic of an ingredient. With respect to efficacy tests, the FDA’s regulation on SPF testing of monograph products) (21 CFR 201.327) should be done. Overall, according to FDA the proposed studies are not novel and are consistent with FDA’s standard data requirements for approval for topical drug products for chronic use.

The above mentioned guidance’s were open for comment until January 22, 2016. An interesting point raised is FDA’s discussion on possible requirements for final formulation testing. At the present time, FDA has not yet indicated if final formulation testing will be required; however, they are looking to the industry to provide a scientifically persuasive rationale as to why such testing would not be necessary OR alternative approaches to the one described in the draft guidance. Lastly, an impact on an increase in the availability of sunscreen ingredients remains to be seen as a result of the Sunscreen Innovation Act.

dicentra can assist in reviewing sunscreen products & ingredients for safety and efficacy, and can provide guidance on active sunscreen ingredients for the US market. We can be reached at 1-866-647-3279 or

Natural Products Insider – Regulatory Updates: Rishi Teas – May 6, 2011

FDA Warns Rishi Teas for Website Claims

April 26, 2011

MINNEAPOLIS, Minn.—FDA warned Diaspora Tea & Herb Co. LLC that some of its Rishi Teas were promoted for conditions that cause them to be considered drugs. In an April 20 letter from Gerald J. Berg, director, FDA’s Minneapolis District Office, the agency said Rishi Tea’s website promotes Oolong Tea, Ginger, Organic Botanical, Green Oolong Tea, 100% Premium Tealeaf Powder and Pu-erh Tea as drugs under section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1)(B).

The letter was issued to Joshua Kaiser, president and co-owner, Diaspora Tea & Herb Co., and said the Internet claims establish these products as drugs because they were described as intended for use in the cure, mitigation, treatment or prevention of disease.

Additionally, FDA determined that Diaspora Tea & Herb Co.’s Yerba Maté Shade Grown, Organic Yerba Maté, White Tea, Pu-erh Tea, Green Oolong Tea, 100% Premium Tealeaf Powder, Matcha, 100% Premium Tea Powder, Blueberry Rooibos, Organic Fair Trade Rooibos Blend, Green Rooibos (Green Bush), Organic Fair Trade Botanical and Super Green, Organic Japanese Green Tea products are also misbranded within the meaning of section 403(r)(1)(A) of the Act, 21 U.S.C. § 343(r)(1)(A).

POMELLA® Gains Two More U.S. Patents

April 27, 2011

NOBLESVILLE, Ind.–Verdure Sciences received two new U.S. patents for applications covering the composition and methodology of POMELLA® pomegranate extract brands. The patents (numbers 7,897,791 and 7,919,636), granted in 2011, are in addition to U.S. Patent 7,638,640 secured by Verdure Sciences in 2009.

“The new patents mark a significant milestone for the POMELLA® brand, and we are proud to see our efforts validated by further patent protections,” said Sonya Cropper, vice president marketing for Verdure Sciences. “The POMELLA® brand continues to set industry standards in pomegranate bioavailability, quality, and punicalagin content.”

The POMELLA® Pomegranate Extract brand product, developed by a California research university, is clinically researched and standardized to a patented composition, including the antioxidant-rich punicalagins. Verdure Sciences recently released a white paper on pomegranates titled “New Research on Pomegranate Punicalagins.”

Manufactured under GMP (good manufacturing practices)-registered, ISO-certified standards, POMELLA® extract is natural, kosher-certified and GMO-free. Verdure Sciences offers bionutritionals through the integration of agricultural networks, manufacturing control and university-based research.

“Proven” Proves to be Hit in EU Health Claims

April 28, 2011

DUIVEN, The Netherlands—“Proven” is the new buzzword in European food health claims, according to market researcher Innova Market Insights, which reported 36-perent growth in the number of products with a health positioning that use the word “proven” in Western Europe in 2010 versus 2009.

Innova suggested this may be due to the fourth batch of generic EU health claim opinions recently delivered by the European Food Safety Authority (EFSA) in April, which were more likely to grant successful opinions to companies that promote words like “proven” and “scientific support.” Manufacturers, it reported, are also opting for softer or passive claims (e.g. “low and light”) as the uncertainty around health claims continues.

Innova Market Insights noted a 4-percent decline in the number of “active health” launches tracked in Western Europe in 2010 (e.g. “functional” and “fortified” products), compared to 2009, despite 25-percent growth in the number of “passive health” (i.e. “food minus”) launches tracked.

Along with “proven” and softer claims, Innova Market Insights also identified eight other emerging trends that will affect new product activity in the nutritional and functional foods space.

Superfruits Conference Set in China

May 2, 2011

BEIJING—China is well known as a leading supplier of superfruit ingredients and raw materials, such as goji and sea buckthorn, but it’s evolving role as a destination for finished products will also be discussed at the first “China Anti-oxidant Berry & Super Fruit Industry Conference,” scheduled for May 26 and 27, 2011.

The event is being organized by the Ministry of Commerce’s Chamber for Natural Products,, and the Center for Public Nutrition and the Ministry of Water Resources in order to focus on the quickly developing superfruit ingredient category for food, dietary supplements and cosmetics. China is home to a growing number of super fruits. The conference will bring together industry experts from China and abroad to discuss the industry’s latest research, current applications and future prospects.

FDA Discourages Infant Botanical Use

May 2, 2011

COLLEGE PARK, Md.—The first study of botanical supplement and tea use in infants found 9 percent of children 1 year and younger were given herbs (Pediatrics DOI:10.1542/peds.2010-2294). However, the study, performed by FDA, cautioned such practices may cause harm because herbs are not regulated in the same way as prescription drugs.

Mom’s use (P<0.0001), longer breastfeeding (P<0.0001), and being Hispanic (P=0.016) also increased the rates of infants receiving botanical supplements or teas. Older married mothers with a higher education or higher income were also more likely to give their infant herbal supplements or teas. Geographically, giving botanical supplements and teas to infants was most common in the West and least common in the Midwest.

The most common supplements given were gripe water, chamomile, teething tablets and unspecified tea, and the four most common reasons mothers fed botanicals to their infants were to help with fussiness, digestion, colic and relaxation. Mothers listed a variety of botanical information sources including friends or relatives (30 percent), the media (28 percent) and the health care professionals (27 percent).