By Lisa R. Burchi and Barbara A. Christianson

On February 22, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced that it will co-host a virtual public meeting with the U.S. Food and Drug Administration’s (FDA) Center of Veterinary Medicine (CVM) on March 22, 2023. As stated in our February 17, 2023, blog, EPA and FDA are considering how best to update their respective oversight responsibilities for specific products in an efficient and transparent manner and in alignment with each agency’s expertise. According to EPA, the purpose of the comment period and virtual public meeting is to obtain feedback from stakeholders on ideas for modernizing EPA’s and FDA’s approach to product oversight.

EPA also has opened a docket for the agencies to receive comments on their current approach to the oversight of various products regulated as either pesticides by EPA or new animal drugs by FDA, with a focus on parasite treatment products applied topically to animals and in genetically engineered pest animals for use as pest control tools. EPA posted to the docket, and is requesting comments on, a document entitled, “WHITEPAPER: A Modern Approach to EPA and FDA Product Oversight,” (Whitepaper) which describes the current challenges and highlights the potential benefits of a modernized approach to oversight of these products. The Whitepaper is available at EPA-HQ-OPP-2023-0103, and comments on the Whitepaper are due on or before April 24, 2023.

In the Whitepaper, EPA focuses on two particular product types:

• Products administered topically to animals (e.g., flea and tick collars): EPA states that the “agencies have historically determined oversight for products topically administered to animals to treat fleas and ticks based on whether the chemical is systemically absorbed into the bloodstream (FDA oversight) or remains on the skin (EPA oversight).” Based on new understandings that many of these topically administered products regulated by EPA are systemically absorbed into the bloodstream as well as agreement by the agencies that FDA is better equipped to evaluate and monitor products topically administered to animals, the agencies are considering the transfer of approximately 600 topically administered products for external parasites on animals currently regulated by EPA to FDA.
• Genetically engineered pest animals (e.g., mosquitoes genetically engineered to control the mosquito population in the environment): EPA states a new approach can “provide the agencies with more flexibility to update and align their regulatory oversight of relevant products consistent with each agency’s mission and expertise.” No specific proposal is offered, although EPA notes that it “may need resources to expand its existing biotechnology program for products to control populations of pest animals and clarify the program’s approach to meet the needs of this growing industry.”

EPA announced that registration for the virtual public meeting is available and closes at 11:59 p.m. (EDT) on March 15, 2023. Requests for oral presentations must be made by March 15, 2023. Comments can be submitted in regulations.gov under docket EPA-HQ-OPP-2023-0103 until April 24, 2023. To register to attend the public meeting, visit https://www.eventbrite.com/e/547810324427.

Additional information is available at:

• Virtual Public Meeting: FDA and EPA Product Oversight
• Federal Register Notice
• Whitepaper: A Modern Approach to EPA and FDA Product Oversight

Commentary

Stakeholders are urged to review the information EPA has made available and consider commenting upon these proposed changes and potentially other EPA-FDA jurisdictional issues. The current focus on products administered topically to animals may seem narrow, but there are broader implications both for this category and for other EPA-FDA jurisdictional issues. It is unclear, for example, if the agencies have sufficiently considered EPA’s expertise in evaluating risks to the environment that may be at issue for many products administered topically to animals, as these products are not limited to flea and tick collars as described in the Whitepaper. Besides this one proposal to transfer jurisdiction for these products from FDA to EPA, there are few concrete details or proposals, leaving open the possibility to submit comments to the agencies regarding other areas where industry has struggled to determine which agency has authority over certain products, components, and devices.

• Email This
• Print
• Comments

By Lisa R. Burchi and Barbara A. Christianson

On February 15, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) and the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) announced plans to seek public input on the best approaches for updating their respective oversight responsibilities for specific products. EPA states the goal is to determine responsibilities in an efficient and transparent manner and in alignment with each agency’s expertise, thereby improving protection of human, animal, and environmental health.

EPA and FDA will hold a joint virtual public meeting on March 22, 2023, to provide information and receive public comment on the agencies’ current approaches for the oversight of various products regulated as either pesticides or new animal drugs. EPA and FDA state that members of the public will have the opportunity to comment during the meeting, and a docket will be available for the submission of written comments.

As background, EPA and FDA currently determine regulatory oversight of pesticides and new animal drugs based on the rationale described in a Memorandum of Understanding (MOU) between the agencies signed in 1971 and revised in 1973. Since that time, pesticide and animal drug technologies, and both agencies’ understanding of these technologies, have evolved. Examples provided include the following:

• Parasite treatment products applied topically to animals are regulated by EPA if they remain on the skin to control only external parasites (e.g., fleas, ticks) and by FDA if they are absorbed systemically into the bloodstream to control internal parasites (e.g., intestinal worms). The agencies state they now understand that many of the topically administered products currently regulated by EPA may not remain on the skin and are instead absorbed into the bloodstream. EPA and FDA are thus questioning the current approach and potentially different safety concerns.

• Genetically engineered (GE) pest animals, which are gaining interest as a pest control tool, were not envisioned 50 years ago when the original regulatory approach was developed. As agreed in the 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products, EPA and FDA have considered how to update their respective responsibilities with the goal of developing an efficient, transparent, and predictable approach for overseeing GE insects and other pest animals. Recently, Executive Order 14081, issued September 12, 2022, further directed the agencies to improve the clarity and efficiency of the regulatory process for biotechnology products, underscoring the need for continued coordination between the agencies on biotechnology.

In its notice, EPA acknowledges that the current approach to determining whether EPA or FDA is the appropriate regulator of certain products “does not effectively reflect or accommodate scientific advancement, and it has become clear in some cases that the current approach has resulted in misalignment between product characteristics and the agency better equipped to regulate the product.” EPA states further that “[a] modernized approach would ensure that the oversight of these products better aligns with each agency’s expertise, accounts for scientific advancement, avoids redundancy, better protects animal health and safety, and improves regulatory clarity for regulated entities, animal owners, veterinarians, and other stakeholders.”

Additional information about how to participate in the public meeting, including more detailed information describing challenges with the current approach, and how to submit public comments, will be posted on both FDA’s and EPA’s websites.

Commentary

The MOU at issue is outdated and presents considerable challenges for companies trying to determine the legal and regulatory construct for certain products. This notice thus is a significant development and potential opportunity to address numerous issues with the current jurisdictional divide between EPA and FDA. EPA has provided some clear examples where updated policies and approaches will be beneficial, but there are many more products to be considered. There also are other jurisdictional questions between EPA and FDA for other products that do not appear to be part of the current initiative, including antimicrobial products and medical/pesticide devices. The process being initiated now has the potential to provide much needed clarity for certain products and potentially pave the way for the agencies to consider further public input beyond the scope of the current notice.

• Email This
• Print
• Comments

 
October 26, 2022
12:00 p.m. - 1:00 p.m. (EDT)

The U.S. Food and Drug Administration (FDA) reports that 48 million people in the United States (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. In 2011, President Obama signed into law the Food Safety Modernization Act (FSMA) in part to address this significant public health issue. FSMA is a comprehensive law intended to shift the focus of foodborne illness management from responding to outbreaks to preventing them. FSMA consists of seven major rules, each meant to improve the safety and sustainability of the nation’s food supply, regardless of its country of origin, and identify clear, specific actions to achieve enhanced food safety.

This webinar will focus on FSMA and discuss the incremental progress the law has achieved in assuring food safety.  In addition, the webinar will include a look at the New Era of Smarter Food Safety, a 2020 initiative meant to enhance FSMA, and improve food safety outcomes by leveraging technology. Register now to join Thomas J. Dunn, Karin F. Baron, and Lynn L. Bergeson for the Bergeson & Campbell, P.C. (B&C^®) sponsored webinar, “Food Safety Issues in the United States.”
 
Topics Covered:

• Review of FSMA
• Discussion on food safety over the past decade
• New Era of Smarter Food Safety

Speakers Include:
 
Thomas J. Dunn, Managing Director, Flexpacknology llc, has been an active practitioner in the flexible packaging industry since 1979, with significant responsibilities as an associate with the Flexible Packaging Association and Printpack Inc. He supplemented his professional accomplishments with leadership roles in industry associations (FPA, RadTech NA) and professional societies (TAPPI, SPE, IFT). Dunn has authored peer-reviewed papers, served on U.S. Department of Agriculture (USDA) grant proposal review panels, and contributed content to major technical publications in the industry.
 
Karin F. Baron, MSPH, Senior Regulatory Consultant, B&C, has more than 20 years’ experience developing, implementing, and managing complex chemical regulatory compliance matters for some of the largest industrial and specialty chemical companies in the world. Her primary areas of practice include hazard and risk assessment and communication, industrial hygiene and environmental health and safety (EHS) programs, FDA regulations pertaining to food contact materials, and the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), including compliant safety data sheets (SDS).
 
Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to industrial biotechnology, synthetic biology, and other emerging transformative technologies. She counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.

REGISTER NOW

• Email This
• Print
• Comments

By Lisa M. Campbell and Carla N. Hutton

The Food and Drug Administration (FDA) published a Federal Register notice on October 13, 2021, announcing the withdrawal of three guidance documents: “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)”; “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency”; and “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).” 86 Fed. Reg. 56960. According to the notice, FDA is withdrawing the guidance documents “because current data indicate that consumers and healthcare personnel are no longer experiencing difficulties accessing alcohol-based hand sanitizer products, and these temporary policies are no longer needed to help meet demand for alcohol-based hand sanitizer products or for alcohol for use in alcohol-based hand sanitizer.” The withdrawal date for the guidance documents is December 31, 2021. The notice states that firms manufacturing alcohol under the temporary policies for use in alcohol-based hand sanitizers and firms preparing alcohol-based hand sanitizers under the temporary policies must cease production of these products by December 31, 2021. Firms must cease, by March 31, 2022, distribution of any remaining hand sanitizer products that were prepared under the temporary policies before or on December 31, 2021. After March 31, 2022, FDA states that it intends to cease its temporary policy of not taking action with regard to distribution of hand sanitizers, or alcohol for use in alcohol-based hand sanitizers, prepared consistent with the circumstances described in the guidance documents.

Commentary

The withdrawal of these documents is not unexpected. FDA issued the documents in March 2020 to provide regulatory flexibility to certain firms to help meet the demand for alcohol-based hand sanitizer during the COVID-19 public health emergency (PHE). FDA states that it has determined that the demand for alcohol-based hand sanitizer has decreased and the supply of hand sanitizer from traditional manufacturers (i.e., firms other than those that entered into the over-the-counter drug industry for the first time to supply hand sanitizers during the PHE) has increased. FDA notes that although the temporary policies are being withdrawn, firms may continue to manufacture alcohol-based hand sanitizer products without an approved application, provided they comply with the applicable tentative final monograph and other applicable requirements, including current good manufacturing practice requirements under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. FDA reminds distributors, re-packagers, and importers that they are also responsible for the safety and quality of the drugs they introduce into interstate commerce. Firms that registered and submitted drug product listing(s) for hand sanitizer(s) only but no longer manufacture such product, or plan to cease manufacturing such product, can deregister and delist their hand sanitizer product listing(s) by following the Electronic Drug Registration and Listing Instructions.

• Email This
• Print
• Comments

By Lynn L. Bergeson and Carla N. Hutton

Last week, press reported that the U.S. Food and Drug Administration (FDA) would assess distilleries making hand sanitizer $14,060 in fees as Monograph Drug Facilities (MDF) under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021.  Several days later, on December 31, 2020, the Department of Health and Human Services (HHS) Office of Public Affairs tweeted a statement from Brian Harrison, HHS Chief of Staff.  According to the statement, HHS has “directed FDA to cease enforcement of these arbitrary, surprise user fees.”  FDA announced the fee rates on December 29, 2020.  85 Fed. Reg. 85646.  According to the notice, MDFs are exempt from FY 2021 facility fees if they had ceased OTC monograph drug activities and updated their registration with FDA to that effect, prior to December 31, 2019 -- an impossibility for distilleries that began making hand sanitizer in 2020 in response to the COVID-19 pandemic.

According to the complete HHS statement, posted by the Distilled Spirits Council, FDA’s March 2020 guidance document, Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), “contains no discussion regarding user fees or any indication such fees would be due by these entities, many of which would be entering the drug manufacturing business for the first time.”  HHS states that FDA’s action “was not cleared by HHS leadership, who only learned of it through media reports.”  The HHS Office of the General Counsel (OGC) reviewed the matter and “determined that the manner in which the fees were announced and issued has the force and effect of a legislative rule.  Only the HHS Secretary has the authority to issue legislative rules, and he would never have authorized such an action during a time in which the Department is maximizing its regulatory flexibility to empower Americans to confront and defeat COVID-19.”  Because HHS OGC has determined the FDA’s notice is a legislative rule and that no one at FDA has been delegated authority to issue such a rule, HHS states that the notice is void.  HHS leadership, based on the legal opinion, has ordered FDA’s Federal Register notice to be withdrawn, “meaning these surprise user fees will not need to be paid.”

Commentary

The decision comes as a huge relief to businesses far beyond the distillery industry.  FDA is to be commended for ensuring well-intended businesses that redeployed their infrastructure for all the right reasons were not inadvertently penalized for stepping up.

• Email This
• Print
• Comments

By Lisa M. Campbell, Timothy D. Backstrom and Kelly N. Garson

On April 29, 2020, the U.S. District Court for the District of Utah issued a temporary restraining order (TRO) to halt the sale of a fraudulent coronavirus (COVID-19) treatment.  The U.S. Department of Justice (DOJ) announced the court’s decision in an effort to halt the sale of silver products fraudulently claimed to prevent and cure COVID-19.

DOJ filed a civil complaint on April 27, 2020, against defendants Gordon Pedersen of Cedar Hills, Utah and his companies, My Doctor Suggests LLC and GP Silver LLC.  The complaint alleges that defendants began fraudulently promoting and selling various silver products in early 2020 with claims that the silver products would treat and prevent COVID-19.  Some of the alleged false and misleading claims made by defendants include that having silver particles in the bloodstream would block the virus from attaching to cells, that silver would “usher” the virus out of the body, and that silver would destroy all forms of viruses and protect against COVID-19. 

The U.S. Food and Drug Administration (FDA) issued a statement on the Utah case that “FDA will continue to help ensure those who place profits above the public health during the COVID-19 pandemic are stopped” and that FDA is “fully committed to working with the Department of Justice to take appropriate action against those jeopardizing the health of Americans by offering and distributing products with unproven claims to prevent or treat COVID-19.”

The enforcement action will be prosecuted in a coordinated action by the U.S. Attorney’s Office for the District of Utah and the DOJ Civil Division Consumer Protection Branch, with the assistance of the FDA’s Office of Criminal Investigations and Office of the Chief Counsel.  In addition to the TRO, prosecutors obtained a separate court order temporarily freezing the defendants’ assets in order to preserve the court’s ability to grant effective final relief and to maintain the status quo.  A hearing on the DOJ’s request for a preliminary injunction is set for May 12, 2020.  If the case proceeds to trial, the government will need to prove its allegations to obtain a permanent injunction against the defendants. 

In another case, DOJ announced on April 17, 2020, that the United States District Court for the Southern District of Florida issued a TRO to halt the sale of an unapproved and potentially dangerous industrial bleach product being marketed as a “miracle” treatment for COVID-19.  The FDA and the U.S. Federal Trade Commission (FTC) had issued a warning letter to the defendant, Genesis II Church of Health and Healing, on April 8, 2020.  According to the FDA, oral ingestion of the defendant's product called the Miracle Mineral Solution can cause nausea, vomiting, diarrhea, and severe dehydration.  The FDA and the FTC have issued nearly 40 separate warning letters in 2020 to companies selling unapproved or misbranded products with claims to prevent or to treat COVID-19.

Commentary

Particulate elemental silver and silver salts can be effective antimicrobial agents, and numerous products containing these active ingredients are currently registered for various antimicrobial uses.  The U.S. Environmental Protection Agency, along with other federal agencies, are working to ensure that necessary reviews and approvals of legitimate products intended to address COVID 19 are as expeditious as possible.  Products that need these regulatory reviews and approval, but that are marketed without them, are and will likely continue to be a current enforcement focus.

• Email This
• Print
• Comments

By Lisa R. Burchi and Barbara A. Christianson

On March 10, 2020, the Federal Trade Commission (FTC) and U.S. Food and Drug Administration (FDA) announced that warning letters were sent to seven companies for allegedly selling unapproved products that may violate federal law by making deceptive or scientifically unsupported claims about their ability to treat coronavirus (COVID-19).  The warning letters are the first issued by the Agencies alleging unapproved and/or unsupported claims that products can treat or prevent COVID-19/coronavirus.

The agencies sent the letters to the following companies:

1. Vital Silver;
2. Quinessence Aromatherapy Ltd.;
3. N-ergetics;
4. GuruNanda, LLC;
5. Vivify Holistic Clinic;
6. Herbal Amy LLC; and
7. The Jim Bakker Show.

Each of the seven companies have advertised products as able to treat or prevent COVID-19/coronavirus.  The unapproved products include teas, essential oils, and colloidal silver.

According to FDA, there are no approved vaccines, drugs, or investigational products currently available to treat or prevent the virus.  FDA Commissioner Stephen M. Hahn, M.D. stated: “The FDA considers the sale and promotion of fraudulent COVID-19 products to be a threat to the public health.  We have an aggressive surveillance program that routinely monitors online sources for health fraud products, especially during a significant public health issue such as this one.  The FDA’s laws are designed to protect the public health by ensuring, among other things, that drugs are safe and effective for their intended uses.”

The letters state that one or more of the efficacy claims made by the marketers are unsubstantiated and therefore may violate the FTC Act.  The letters advise the recipients to cease immediately making all claims that their products can treat or cure coronavirus. 

FTC Chair Joe Simons stated: “There already is a high level of anxiety over the potential spread of coronavirus.  What we don’t need in this situation are companies preying on consumers by promoting products with fraudulent prevention and treatment claims.  These warning letters are just the first step.  We’re prepared to take enforcement actions against companies that continue to market this type of scam.”

Commentary

FTC and FDA have pledged to continue to monitor social media, online marketplaces, and incoming complaints to ensure these products do not continue to make such claims.  The letters sent emphasize that, if the false claims do not cease, FTC may seek a federal court injunction and an order requiring money to be refunded to consumers and instructing the recipients to notify the FTC within 48 hours of the specific actions they have taken to address FTC’s concerns.

In addition, the FTC recently issued a new consumer blog post with information about how to identify and avoid coronavirus-related scams.  Coronavirus: Scammers follow the headlines notes that scammers are creating websites to sell bogus products, and using fake emails, texts, and social media posts as a ruse to take consumers’ money and obtain personal information.  It then warns consumers of the “red flags” to monitor when shopping for products related to the virus.

EPA also has been active in this area, announcing the release of a new list of EPA-registered disinfectant products that have qualified for use against SARS-CoV-2, the coronavirus that causes COVID-19 and also announcing its process for expediting review of submissions made by companies that are requesting to add Emerging Viral Pathogen claims to its labels of already-registered surface disinfectants. 

• Email This
• Print
• Comments

By Timothy D. Backstrom

On January 9, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced the launch of a new website created in coordination with the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) that provides information about actions the federal government is taking to oversee the development of agricultural biotechnology products.  This “one-stop-shop” website was created under the direction of Executive Order (EO) “Modernizing the Regulatory Framework for Agricultural Biotechnology Products.”

EPA regulates biotechnology-based pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and residues from such pesticides under the Federal Food, Drug and Cosmetic Act (FFDCA).  EPA also regulates under the Toxic Substances Control Act (TSCA) certain new microorganisms that are not subject to regulation under other statutes.  USDA regulates certain new biotechnology products under the Plant Protection Act (PPA), including agricultural crops that have been modified to be resistant to conventional pesticides.  FDA regulates the safety of human and animal foods produced using biotechnology, including genetically modified agricultural crops and animals, and the safety of drugs and human biologics produced with biotechnology, under the FFDCA.

The website, The Unified Website for Biotechnology Regulation, describes the federal review process for biotechnology products, outline’s each agency’s role in regulating biotechnology products, and allows users to submit questions to the three agencies.  EPA Administrator Andrew Wheeler states that the new website “will help provide regulatory certainty and clarity to our nation’s farmers and producers by bringing together information on the full suite of actions the Trump Administration is taking to safely reduce unnecessary regulations and break down barriers for these biotechnology products in the marketplace.”

Commentary

In recent years, a number of Non-Governmental Organizations (NGO) have raised concerns regarding the risks from products that have been genetically modified using biotechnology, including agricultural crops that have been genetically modified to improve pesticide or disease resistance, and agricultural animals that have been genetically modified to enhance food production.  In some instances, farmers have also expressed concern that crops with novel traits may exchange genetic information with other plant strains or species.  Implicit in all of this criticism is a presumption that the agencies with regulatory jurisdiction over these novel organisms have not adequately prevented or mitigated the risks associated with biotechnology.

In contrast, proponents of biotechnology have complained that regulatory requirements imposed by the responsible agencies have stifled useful innovation and have requested relief from regulatory requirements that they contend have impeded or slowed introduction of new products of agricultural biotechnology.  The Executive Order that underlies the new website seeks to streamline the administrative process for introducing novel agricultural products without increasing potential risks of biotechnology.

Additional information on how EPA regulates biotechnology products is available here.

• Email This
• Print
• Comments

By Lisa M. Campbell and Heather F. Collins, M.S.

On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was making final a single correction to the data requirements for antimicrobial pesticide products codified in 40 C.F.R. Part 158, subpart W.  84 Fed. Reg. 18993.  The correction clarifies that the 200 parts per billion (ppb) level described in the antimicrobial pesticides data requirements regulations (40 C.F.R. § 158.2230(d)) “is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food,” as EPA states was incorrectly implied by the previous regulatory text.  EPA initially proposed this change on August 18, 2017 (82 Fed. Reg. 39399) because it agreed to do so in a settlement agreement with the American Chemistry Council (ACC) after ACC filed a petition for review of the 2013 final rule titled “Data Requirements for Antimicrobial Pesticides” (78 Fed. Reg. 26936 (May 8, 2013)) in the U.S. Court of Appeals for the District of Columbia Circuit.  Specifically, EPA agreed to make this correction to “make the language consistent” with the U.S. Food and Drug Administration’s (FDA) policy set forth in FDA’s “Guidance for Industry, Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations. Final Guidance. April 2002.”  EPA states that the change is intended to “enhance understanding of the data required to support an antimicrobial pesticide registration and does not alter the burden or costs associated with these previously promulgated requirements” and that it is not establishing “any new data requirements or any other revisions (substantive or otherwise) to existing requirements.”  The final rule will become effective on July 2, 2019.

• Email This
• Print
• Comments

By Carla N. Hutton

The U.S. Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.  The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded.  Under the proposed rule, products that combine sunscreens with insect repellents would not be GRASE.  Publication of the proposed rule in the Federal Register will begin a 90-day comment period.

Sunscreen-insect repellent products are jointly regulated by FDA as sunscreen drugs and by the U.S. Environmental Protection Agency (EPA) as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  On February 22, 2007, FDA and EPA both issued advance notices of proposed rulemaking (ANPR) requesting comment on the appropriate regulatory status of these products.  FDA published a notice seeking information to formulate a regulatory position on insect repellent products that contain OTC sunscreen ingredients.  72 Fed. Reg. 7941.  EPA published a similar notice announcing that it was also seeking information to determine how insect repellent-sunscreen combination products should be regulated to complete the reregistration review described in the Reregistration Eligibility Decision document for the insect repellent N,N-diethyl-meta-toluamide (DEET). 72 Fed. Reg. 7979.

In the proposed rule, FDA states that it reviewed comments submitted in response to the 2007 ANPRs, as well as pertinent scientific literature and publicly available EPA regulatory documents.  Based on that review, FDA has tentatively concluded that sunscreen-insect repellent combination products, as a class, are not GRASE and are misbranded because conflicting labeling requirements for the sunscreen and insect repellent components cannot be reconciled to create labeling that will sufficiently ensure the safe and effective use of the sunscreen component, as well as adequate directions for use as a sunscreen.  FDA states that even if it did not have this labeling concern, it would still tentatively determine that available data regarding the safety and effectiveness of these products for their use as sunscreens are insufficient to classify these sunscreen products as GRASE for such use.  Specifically, according to FDA, evidence suggests that interactions between some sunscreen active ingredients and insect repellents may decrease safety by increasing systemic absorption of one or both components, and potential synergistic effects on the efficacy of sunscreen active ingredients apparently have not been studied.  

The proposed rule states that FDA tentatively determines that sunscreen-insect repellent combination products are not GRASE for nonprescription sunscreen use.  FDA seeks comment on this tentative determination.  Publication of the proposed rule in the Federal Register on February 26, 2019, will begin a 90-day comment period.  More information on the proposed rule is available in our memorandum, "FDA Will Publish Proposed Rule for OTC Sunscreen Drug Products."

• Email This
• Print
• Comments