- On November 1, President Trump announced his intent to nominate Dr. Stephen Hahn to be the new FDA Commissioner. Dr. Hahn is a radiation oncologist and currently serves as the Chief Medical Officer of MD Anderson Cancer Center in Houston, Texas. At MD Anderson, Hahn manages a $5.2 billion operating budget, 20,300 employees, 7,000 trainees and more than 3,000 volunteers. He has never served in a government post.
- As our readers may recall, the change in FDA leadership stems from former FDA Commissioner Scott Gottlieb’s resignation in April. Gottlieb was confirmed as FDA Commissioner in May 2017 and drove several significant initiatives from food safety modernization to youth nicotine use. In April, Dr. Ned Sharpless replaced Gottlieb as Acting Commissioner of Food and Drugs. It had been assumed that Dr. Sharpless would remain the Acting Commissioner until Dr. Hahn was confirmed. However, due to the Federal Vacancies Reform Act, Dr. Sharpless’s term with the Agency expired on November 1. The Act requires that a person may not serve in an “Acting” capacity for longer than 210 days. Dr. Sharpless has since returned to his role as Director of the National Cancer Institute (NCI).
- According to a press release from U.S. Secretary of Health and Human Services Alex Azar, Admiral Brett Giroir, Assistant Secretary for Health, will oversee the FDA, pending Dr. Hahn’s confirmation. In the press release, Secretary Azar stated that “Admiral Giroir has been an indispensable leader for HHS on a number of public health priorities. As Assistant Secretary for Health, whose authorities include overseeing the U.S. Public Health Service, he will be able to assume the delegable duties of the Commissioner at this time and ensure the FDA’s work continues to move forward.”
- PFAS, which is a catch-all term for a family of human-made substances known for their grease, water, and oil-resistant properties, are widely used in a variety of everyday products such as fabrics, cleaning products, and paints. They are also authorized for a limited number of uses in cookware and certain food packaging applications.
- FDA has been engaged in working to develop new methods to quantify PFAS in foods and has conducted test samples of foods Americans typically consume for certain types of PFAS. In June, FDA released a statement highlighting the Agency’s efforts and outlining some of the initial results of the testing. At that time, FDA reported that 14 of the 91 samples evaluated contained PFAS.
- In its October 31 statement, FDA made available a scientifically validated method for testing for 16 types of PFAS in a variety of food. After applying the validated method to the initial results, FDA said that detectable levels of certain PFAS chemicals were found in only two of 91 samples, ground turkey and tilapia. The agency will continue to analyze additional samples and make those results available this year.
- The FDA Food Safety Modernization Act (FSMA) directs FDA to establish a program for the testing of food by accredited laboratories. Under this program, FDA must recognize accreditation organizations that accredit food testing laboratories and adopt model accreditation standards that such laboratories must meet.
- On November 1, 2019, FDA released a proposed rule under which FDA will recognize accreditation bodies, which will, in turn, accredit laboratories to conduct food testing. FDA’s proposed laboratory accreditation program partially incorporates two globally recognized and widely used voluntary consensus standards, ISO/IEC 17011:2017 and ISO/IEC 17025:2017, as foundational requirements for accreditation bodies and laboratories, respectively. Once the laboratory accreditation program is established, testing of human and animal food in certain circumstances must be conducted by an accredited laboratory and the results must be sent directly to FDA. A full test report is required unless the testing laboratory meets FDA’s proposed provisions for submitting an abridged report. Circumstances where testing by an accredited laboratory would be required include:
– To comply with specific FDA testing requirements applied to address an identified or suspected food safety problem (including certain tests of shell eggs, bottled water, and sprouts);
– To provide evidence on the admissibility of imported food (e.g., for a food that has been detained due to an appearance of adulteration);
– To support the removal of a food from an import alert through successful consecutive testing;
– To address an identified or suspected food safety problem and provide evidence for an informal hearing before a mandatory recall order, as part of a corrective action plan submitted after an order suspending the registration of a food facility, or as part of evidence submitted for an appeal of an administrative detention order;
– To respond to a “food testing order,” which is a new procedure proposed by this rule to address an identified or suspected food safety problem.
- Laboratories run and operated by federal agencies, states, localities, and foreign government entities, as well as private laboratories, including in-house laboratories, will be eligible for accreditation under FDA’s proposed program. Laboratories could be accredited in one or more major disciplines (e.g., microbiology, chemistry, and physical testing). FDA will establish a publicly available list of recognized accreditation bodies and laboratories accredited. Both accrediting bodies and accredited laboratories will be subject to FDA oversight, although accrediting bodies will have primary oversight of accredited laboratories.
- Comments on FDA’s proposed rule are due by March 3, 2020. The laboratory accreditation program would become effective 60 days after a final rule is published; however, FDA will allow itself an unspecified time period after that to get ready to accept applications for recognition from accrediting bodies. Then it will take more time for FDA to recognize a sufficient number of accrediting bodies so that laboratories may then apply for accreditation. In this regard, the compliance date for testing to be conducted by an accredited laboratory participating in FDA’s program would be no sooner than six months after FDA publishes notice of sufficient laboratory capacity. Thus, mandatory testing by an accredited laboratory appears to be a couple of years away at the earliest.
- As previously covered on this blog, food waste is a major issue in the United States. Government estimates indicate that Americans waste between 30 and 40 percent of the overall food supply on an annual basis. According to the United States Department of Agriculture (USDA), consumers are responsible for nearly 90 billion pounds of food waste each year, which equates to 20 percent of the U.S. food supply. And while perfectly good food goes to waste, approximately 40 million Americans are food insecure. USDA, the United States Environmental Protection Agency (EPA), and others have initiated the “Food Loss and Waste 2030 Champions” program, members of which are committing to a 50 percent reduction in food waste by 2030.
- On October 30, the USDA, EPA, and United States Food and Drug Administration (FDA) announced a new partnership with the Food Waste Reduction Alliance (FWRA), formalizing industry education and outreach efforts with FWRA’s founding partners, the Grocery Manufacturers Association, the Food Marketing Institute, and the National Restaurant Association. The new Memorandum of Understanding is part of a larger effort from federal agencies, dubbed the Winning on Reducing Food Waste Initiative, which aims to reduce food loss and waste through community investments, education and outreach, voluntary programs, public-private partnerships, tool development, technical assistance, event participation, and policy discussion.
- The announcement comes on the heels of ongoing Congressional efforts to address food waste, including the establishment of a House Food Waste Caucus and the introduction of legislation designed to end consumer confusion by creating a national standard for date marking of food. The USDA Food Safety and Inspection Service (FSIS) has also initiated efforts to combat food waste, including encouraging manufacturers to use labels that clearly indicate when dates refer to quality, rather than safety, in an effort to dissuade consumers from prematurely disposing of safe food products.
Last week, California’s Department of Toxic Substances Control (DTSC) hosted a webinar where it presented initial findings from its evaluation of food packaging, conducted under its Safer Consumer Products Regulations. During the webinar, DTSC noted that it is considering the prioritization of ortho-phthalates (OPs), bisphenol A (BPA), perfluoroalkyl and polyfluoroalkyl substances (PFASs), and/or styrene in food packaging.
The goal of the Safer Consumer Products Regulations is “to create safer substitutes for hazardous ingredients in consumer products sold in California.” Since the regulations inception in 2013, DTSC has prioritized three products: Children’s Foam-Padded Sleeping Products with TDCPP or TCEP, Spray Polyurethane Foam Systems with Unreacted Methylene Diphenyl Diisocyanates (MDI), and Paint or Varnish Strippers with Methylene Chloride.
To receive additional information from stakeholders, DTSC is hosting a public meeting on November 19, 2019 to discuss OPs and BPA. In addition, DTSC will hold a workshop on PFAS and their alternatives in food packaging on January 14, 2020.
- On October 29, the USDA announced the establishment of the U.S. Domestic Hemp Production Program. As our readers know, the 2018 Farm Bill removed hemp from the Controlled Substances Act and assigned regulation of hemp production to the states with oversight by USDA. The Domestic Hemp Production Program creates a consistent regulatory framework around hemp production throughout the U.S.
- The USDA also announced it will be publishing an interim final rule that outlines provisions for the Program. As detailed in the interim final rule, a State or Indian Tribe that wants to have primary regulatory authority over the production of hemp in that State or territory of that Indian Tribe may submit, for the approval of the Secretary, a plan concerning the monitoring and regulation of such hemp production. State and Tribal plans developed to regulate the production of hemp must include certain requirements when submitted for USDA approval. Those requirements include:
- Land use for production
- Sampling and testing for delta-9-tetrahydrocannabinol (THC) to ensure the cannabis grown and harvested does not exceed the acceptable hemp THC level
- Disposal of non-compliant plants
- Compliance with enforcement procedures including annual inspection of hemp producers
- Information sharing for reporting specific information to USDA
- Certification of resources
- Plan approval, technical assistance, and USDA oversight
Additionally, the interim final rule establishes a federal plan to regulate hemp production by producers in areas where hemp production is legal but not covered by an approved State or Tribal plan. All hemp produced outside of States and Tribes with approved plans must meet the requirements of the USDA plan, which has requirements similar to those under State and Tribal plans, but also requires a USDA hemp producer license. USDA also developed guidelines for sampling and testing procedures that are being issued concurrently with the rule. These documents provide additional information for sampling agents and hemp testing laboratories.
- Overall, the U.S. Domestic Hemp Production Program will provide clarity to the production of hemp and foster further confidence in hemp products; however, the program will not directly impact the regulatory status of consumer products that contain cannabidiol (CBD). A draft of the interim final rule is available on the USDA’s website. Industry stakeholders may submit comments on the interim final rule once published in the Federal Register, which is likely later this week. Keller and Heckman attorneys would be glad to assist interested parties in preparing comments for submission to USDA or advising on how to comply with the U.S. Domestic Hemp Production Program.
- Missouri was the first among many states, including Arkansas, Louisiana, Mississippi, North Dakota, Oklahoma, South Carolina, South Dakota, and Wyoming, to enact laws restricting plant-based and cell-cultured products from being labeled as “meat.” As reported here, Turtle Island Foods (Tofurkey brand), in conjunction with non-profit advocacy groups, filed a lawsuit on August 28, 2018, which is the date Missouri’s law took effect, alleging First Amendment violations. The plaintiffs requested a preliminary injunction on October 30, 2018. Before a ruling was made on the injunction request, litigation was suspended for negotiations but then resumed in July 2019 after settlement discussions failed.
- AP News reported on October 4, 2019 that U.S. District Judge Fernando Gaitan Jr. of the Western District of Missouri denied the request for a preliminary injunction because Tofurkey will not be affected by the law in question. Specifically, as Missouri is not expected to prosecute where a non-meat product label using a defined “meat” term also bears a qualifier, such as “vegetarian,” “plant-based,” or “cell-based,” the Judge found there is no risk of prosecution for the plaintiff and no burden from having to change labels because the current labels disclose that Tofurkey products are plant-based. A reported statement from Jessica Almy, an attorney in the case and the Director of Good Food Institute (GFI), a co-plaintiff, however, indicates that GFI has appealed the ruling. In contrast, other plaintiffs in a similar situation will consider dropping a lawsuit in Mississippi upon adoption of a proposed regulation permitting “meat” terms in that state on labels that also use qualifiers.
- In addition to plant-based products that are the subject of ongoing litigation in Missouri and other states, cell-based products derived from muscle tissue cultured in vitro from animal cells are also targeted by states’ meat labeling laws. Cell-based products remain in the research and development phase and, thus, are not truly represented in the current litigation against state meat labeling laws. It is likely, however, that yet-to-be developed federal labeling regulations will ultimately preempt the state laws. In this regard, we have reported that five cell-based meat and seafood companies have formed a coalition to represent the industry’s interest amidst regulatory uncertainty.
- As our readers are aware, in May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products was initially slated for July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales). In May 2018, FDA issued a final rule extending the compliance dates to January 1, 2020 for manufacturers with $10 million or more in annual food sales and January 1, 2021 for manufacturers with less than $10 million in annual food sales.
- In response to recent comments from manufacturers with annual sales exceeding $10 million, FDA announced that it will effectively extend the compliance deadline again by declining to take enforcement actions during the first six months following the January 1, 2020 compliance date. According to a newly published statement from FDA, during this six month period, the agency “plans to work cooperatively with manufacturers to meet the new Nutrition Facts label requirements and will not focus on enforcement actions regarding these requirements during that time.”
- We will continue to monitor developments concerning the compliance date for this rule and will report them to you here.
- As our readers know, the 2018 Farm Bill removed hemp from the Controlled Substances Act and assigned regulation of hemp production to the states with oversight by USDA. The spring Unified Agenda, released in May 2019, indicated that the hemp production rule was to be released as an interim final rule in August. USDA previously stated that it planned to issue the regulations in late 2019, before the 2020 planting season. USDA has not yet released the regulations.
- States are anxiously awaiting AMS’s regulations. In a March 2019 webinar and listening session hosted by USDA, several stakeholders expressed concerns about a number of items, including enforcement, reporting regulations, and import requirements for inputs like hemp seed. The Governor of Maine and the Maine Agricultural Commissioner wrote a joint letter to USDA Secretary Sonny Perdue requesting timely action on the regulations and advising him of the regulatory uncertainty’s effects on farmers, agricultural lenders, and insurers.
- Most recently, at the October 17, 2019 hearing before the Senate Committee on Agriculture, Nutrition, and Forestry, Stephen Censky, Deputy Secretary at the USDA, affirmed that AMS planned to publish the rules soon, and, noted he expects the interim final rule will be available for public comment “within the next couple of weeks.”
- Despite the delay in releasing the hemp production rule, states have already begun submitting industrial hemp production plans to USDA. Kentucky, Pennsylvania, Tennessee, and Wyoming are among the states that have submitted plans. Other states, including California, Maine, Massachusetts, Missouri, and Texas, have plans to submit after USDA promulgates the federal regulations. States that prohibit the production of hemp, including Idaho, South Dakota, Mississippi, and the District of Columbia, are not expected to submit plans to USDA. Even though the 2018 Farm Bill requires AMS to approve or disapprove state plans within 60 days of receiving them, AMS has indicated that it will not review the plans until their final rule is in place.
- On October 10, the FDA and FTC sent a joint warning letter to Rooted Apothecary LLC for illegally selling unapproved drug products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), Parkinson’s and Alzheimer’s disease, among other conditions.
- As described in the warning letter, the FDA and FTC stated that the company used its website, online store, and social media sites to make unfounded claims about its CBD products, some of which were also unlawfully marketed as dietary supplements. Examples of the claims include:
- “Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”
- “Increasing evidence suggests that CBD oil is a powerful option for pain . . . anxiety . . . and autism . . . It seems like an attractive and safe option for children.”
- “CBD oil may have neuroprotective properties and may protect against neurological conditions, such as Parkinson’s and Alzheimer’s disease.”
- “[P]ossible uses for CBD include helping with skin problems such as acne, autism, ADHD, and even cancer. It’s often used in conjunction with traditional treatments to provide extra help. Children can use high amounts of CBD safely and without any risk.”
- Additionally, the FTC was concerned that one or more of the efficacy claims cited may not be substantiated by competent and reliable scientific evidence. Under the Federal Trade Commission Act, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence that substantiates the claims made.
- The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. However, as our readers may recall, in July 2019, the FDA announced their commitment to evaluating potential regulatory pathways for CBD products to be lawfully marketed, and that the Agency would report their progress by early fall 2019. As of today’s blog, the Agency has yet to advise on such pathways. Nonetheless, in a press release related to the October 10 warning letter, Acting FDA Commissioner Ned Sharpless, M.D. stated that the CBD-related warning letters “should send a message to the broader market about complying with FDA requirements.” Additionally, he noted that as the Agency continues to examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains top priority. We will continue to report on developments that impact the use of CBD in FDA regulated products.