- As previously reported on this blog, there has been considerable discussion around the regulation of cell-cultured meat both at the federal and state levels. Earlier this month, USDA and FDA published a formal agreement regarding federal agency oversight of human food produced using cell technology. Under the formal agreement, FDA will oversee cell collection and the development/maintenance of cell banks up and until the harvesting stage, where regulatory oversight will then transfer to USDA, which will conduct inspections of establishments where cultured cells are harvested, processed, packaged, and labeled, in accordance with FSIS regulations.
- However, there have been parallel discussions at the state level, with a focus on the labeling of cell cultured products. For example, an Arizona state lawmaker recently introduced a bill that, if enacted, would make it illegal to label a product as “meat” if it is “not derived from harvested production livestock.” The same restrictions would apply to labeling a product as “chicken,” if it was not once live poultry. The bill, HB2604, was introduced to the Arizona House Committee on Land and Agriculture by David Cook (R-Globe), with specific intention to prevent cell-cultured meat from being labeled “meat.” However, HB2604 was not met without criticism. For instance, some lawmakers questioned whether the bill could withstand a federal preemption legal challenge. And while the bill failed to pass the House, it is up for reconsideration within the month.
- As our readers are aware, Arizona is not the only state stepping into the discussion. Missouri, Nebraska, South Dakota, North Dakota, and several other states have introduced legislation that would prohibit representing a product as meat that is not derived from livestock or poultry. And as interest in cell-cultured meat continues to grow, more states are likely to enter the debate. We will continue to monitor and report on regulatory activity in this area.
‘Dairy Pride Act’ Introduced Again
- As previously reported on this blog, U.S. Senator Tammy Baldwin’s (D-WI) introduction of the Dairy Pride Act in 2017 was met with controversy. On March 14, 2019, Sen. Baldwin, along with Sens. Jim Risch (R-ID) and Mike Crapo (R-ID), reintroduced The Defending Against Imitations and Replacements of Yogurt, milk, and cheese to Promote Regular Intake of Dairy Everyday Act (DAIRY PRIDE Act). The legislation is cosponsored by Sens. Patrick Leahy (D-VT), Debbie Stabenow (D-MI), and Angus King (I-ME), and has been introduced in the House by Representatives Peter Welch (D-VT) and Mike Simpson (R-ID).
- The DAIRY PRIDE Act would prohibit non-dairy products made from nuts, seeds, plants, and algae from being labeled with dairy terms like milk, yogurt, and cheese. It also would require the U.S. Food and Drug Administration (FDA) to issue guidance for nationwide enforcement of mislabeled imitation dairy products within 90 days and require the FDA to report to Congress two years after enactment to hold the Agency accountable for this update in their enforcement obligations. A press release from Baldwin’s office about the Act, explains that FDA has not enforced regulations that define dairy products as being from dairy animals and that has “led to the proliferation of mislabeled alternative products that contain a range of ingredients and nutrients that are often not equivalent to the nutrition content of dairy products.”
- Last year, FDA published in the Federal Register a solicitation for public comment regarding the use of the names of dairy foods in the labeling of plant-based products (for more details see our blog on FDA’s request for comments). The comment period, originally scheduled to end on November 27, 2018, was extended to January 28, 2019. Noting that the comment period has ended, Sens. Baldwin and Risch, Crapo, King, and Leahy wrote a letter to FDA Commissioner Scott Gottlieb and Deputy Commissioner for Food and Policy Response Frank Yiannas on March 14 encouraging them to move forward quickly to begin enforcing FDA’s Standards of Identity for dairy products.
- As previously reported on this blog, FDA’s solicitation for comments on the use of dairy terms in labeling plant-based product resulted in more than 13,000 comments, with strong opinions on both sides. We will continue to report on this strongly debated issue.
Data Call-in for Reproductive Toxicity Data on Cannabis Under California’s Proposition 65
- The California Office of Environmental Health Hazard Assessment (OEHHA) has tasked the Developmental and Reproductive Toxicant Identification Committee (DARTIC) of OEHHA’s Science Advisory Board with evaluating whether cannabis (marijuana), marijuana (cannabis) smoke, cannabis extracts, and Δ-9-Tetrahydrocannabinol (THC) have been shown to cause reproductive toxicity (developmental toxicity endpoint). Chemicals identified as reproductive toxicants by the DARTIC are added to the Proposition 65 list.
- OEHHA is initiating the development of hazard identification materials on cannabis chemicals and is requesting scientific information relevant to whether they cause reproductive toxicity (developmental toxicity endpoint). The data call-in period will end at 5:00 p.m. on April 29, 2019. The committee meeting is tentatively planned for Fall 2019, but the exact date is yet to be determined.
- This Proposition 65 development occurs after the U.S. Food and Drug Administration (FDA) showed signs of potentially loosening its opposition to the inclusion of cannabidiol extracts in food or dietary supplements. As reported in this blog, FDA Commissioner Scott Gottlieb had announced the formation of a working group to develop rules that would permit the use of certain extracts from hemp in food or dietary supplements and indicated that a public hearing was being planned for April to discuss how some uses of cannabidiol in food and dietary supplements might be legalized. FDA’s website has no details about an April hearing and it is not clear if Commissioner Gottlieb’s plans to leave FDA at the end of the month will slow work on this matter.
- Keller and Heckman LLP attorneys actively advise clients on compliance issues and enforcement actions related to California’s Proposition 65 and the evolving regulatory status of cannabis-related ingredients. If you have any questions about the data call-in for cannabis or other issues, please email prop65@khlaw.com.
HHS and USDA Announce 2020 Dietary Guidelines Topics and Advisory Committee Meeting
- In February 2018, The Daily Intake Blog reported that the U.S. Department of Health and Humans Services (HHS) and the U.S. Department of Agriculture (USDA) were soliciting “public comments on the proposed priority topics and supporting scientific questions that will guide the development of the upcoming 2020-2025” edition of the Dietary Guidelines for Americans (the 2020 DGA). The DGA is a set of recommendations intended to help people make healthy eating choices and it has been of particular interest as the U.S. Food and Drug Administration (FDA, an agency within HHS) attempts to define “healthy”
- USDA published the topics that the Dietary Guidelines Advisory Committee (the Committee) is to address in providing guidance to HHS and USDA. As expected, HHS and USDA have asked the Committee to stratify and review evidence based on age (and stage of life), sex, race, ethnicity, culture, location, and/or socioeconomic status. Specific topics include:
- Current patterns,
- Nutrients of public health concern,
- Prevalence of nutrition-related chronic health conditions,
- Dietary pattern shift with life stage,
- Impact of
- dietary pattern on growth and disease,
- beverages on growth, achieving nutrient and food group recommendations, and disease,
- added sugars on growth, achieving nutrient and food group recommendations, and disease,
- dietary fats on brain health and various diseases,
- seafood on brain health and various diseases,
- frequency of eating on growth and disease, and
- Infant and Toddler (birth through 24 months) and Pregnant and Lactating Mother specific questions
- The Committee will be holding its first meeting on March 29 at the USDA South Building, Jefferson Auditorium, in Washington, DC and via webcast. The meeting is open to the public, but attendees (in-person or via webcast) must register between March 19 and March 26. The agenda includes:
- review of operations for the Committee members,
- overview of the topics and questions identified by the Departments [HHS and USDA] to be examined by the Committee,
- presentations on evidence-based approaches for reviewing the scientific evidence, and
- plans for future Committee work
- Keller and Heckman will continue to monitor and report on developments relating to the DGA.
FDA Announces New Policies on e-Cigarettes and Cigars to Stem Surge in Youth Smoking
- On March 13, 2019, FDA proposed to end the Agency’s current compliance policy on flavored e-cigarettes (other than tobacco-, mint-, and menthol-flavored products), as well as its policy on flavored cigars, in an effort to curb youth smoking rates. The compliance policy permits “deemed” tobacco products on the market when FDA’s Deeming Rule went into effect on August 8, 2016 to remain on the market until premarket applications are due. Commissioner Scott Gottlieb stated, “Our proposal reflects a very careful public health balance between closing the on-ramp for kids to become addicted to nicotine through tobacco products, while allowing for the promise of an off-ramp for adult smokers through access to potentially less harmful forms of nicotine delivery.”
- In its new draft guidance, FDA also describes focusing its enforcement resources on retail stores “where minors can enter at any time” (e.g., brick-and-mortar convenience stores and online stores with inadequate age-verification software). FDA also puts pressure on manufacturers to use their powers to dictate “terms, conditions, or controls in their contracts with downstream distributors (wholesalers, distributors, importers and/or retailers)” to prevent youth access when sold at retail. This position is consistent with its recent enforcement actions against Walgreens and Circle K stores for youth sales.
- The draft guidance would require manufacturers of all flavored e-cigarette and e-liquid products (other than tobacco-, mint-, and menthol-flavored) to submit premarket applications to the agency by August 8, 2021—one year earlier than previously proposed, which is sure to be a blow to the e-cigarette industry. FDA expects that these policy changes will result in a number of e-cigarette and flavored cigars — which will have to be removed entirely from the market absent FDA marketing authorization — no longer being sold.
- FDA is accepting comments on its draft guidance for 30 days. For more details on this and other tobacco-related news, please see our Continuum of Risk Blog.
FDA Releases Second Installment of Intentional Adulteration Draft Guidance
- FDA released the second installment of a draft guidance designed to support compliance with the Intentional Adulteration (IA) rRule under the Food Safety Modernization Act (FSMA). The first installment was published in June 2018, and a third installment is to follow.
- The second installment outlines two flexible methods for how facilities can conduct vulnerability assessments to identify areas of highest risk, as well as details the mitigation strategies required to significantly minimize or prevent significant vulnerabilities that have been identified. The draft guidance also provides information about education and training requirements for individuals who perform certain activities under the IA rule.
- FSMA’s final IA rule is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to the public health. Unlike other FSMA rules that address specific foods or hazards, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration. In the 2016 IA final rule, FDA identified four key activities that are most vulnerable to intentional adulteration: (1) bulk liquid receiving and loading, (2) liquid storage and handling, (3) secondary ingredient handling, and (4) mixing and similar activities.
- Stakeholders may submit comments on this IA draft guidance until July 5, 2019. Keller and Heckman attorneys are well-versed in FSMA provisions and are available assist interested parties in preparing comments for submission to FDA. For assistance, please email: fooddrug@khlaw.com
FDA Removes Import Alert for GE Salmon
- U.S. Food and Drug Commissioner Scott Gottlieb, M.D., announced on March 8, that the Agency was deactivating a 2016 import alert that prevented genetically engineered (GE) salmon from entering the U.S. By way of background, in 2015, FDA approved a New Animal Drug Application (NADA) related to AquAdvantage Salmon after determining that it met the statutory requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act. AquaAdvantage Salmon contains intentional genomic alterations (IGAs) and is genetically engineered to reach market size more rapidly than its non-GE, farm-raised Atlantic salmon counterpart.
- However, in 2016, Congress directed FDA not to allow food that contains GE salmon into commerce until final GE labeling guidelines were in place. As a result, FDA implemented the import alert that prevented GE salmon from entering the U.S. With the import alert still in place, in 2018, FDA approved a supplemental NADA submitted by Maynard, Massachusetts-based AquaBounty Technologies, Inc. requesting FDA’s approval to raise AquaAdvantage Salmon at a land-based contained facility near Albany, Indiana. The original NADA only specified AquaBounty’s facility on Prince Edward Island, Canada, where the salmon eggs are produced, and the company’s grow-out facility in Panama.
- FDA stated, in a press release, that it believes that the Congressional mandate was satisfied when the U.S. Department of Agriculture (USDA) issued the final rule implementing the National Bioengineered Food Disclosure Standard (for more information on the final rule, see our Dec. 20, 2018 blog). “Therefore, the FDA is deactivating the import alert that prevented food from AquAdvantage Salmon, including salmon eggs used to grow the fish, from entering the U.S.,” the Agency wrote. FDA added that it “is committed to supporting innovation and ensuring safety in the biotechnology space, including the use of IGAs in animals.”
- Not everyone agrees with FDA’s decision. In a press release issued the same day that FDA made the announcement, U.S. Senator Lisa Murkowski (R-AK) stated, “USDA’s new guidelines don’t require adequate mandatory labeling and don’t suffice as giving consumers clear information. Instead, they will only confuse people. I continue to have serious concerns about splicing DNA from two animals to produce a new marketable fish, essentially creating a new species.”
- The next steps for AquaBounty Technologies is to have its Albany, Indiana recirculating aquaculture system (RAS) facility certified by state authorities and then begin production, Sylvia Wulf, the company’s new CEO, told Undercurrent News (registration required). Since once the eggs arrive from Canada it will take about 18 months to grow the fish to market size, Wulf predicted that sales of product from the company’s Albany facility would begin about the third quarter of 2020.
FSIS Issues Draft Guidance to Industry for Responding to Consumer Complaints
- The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) is concerned with an increase in recent years in the number of recalls of meat and poultry products contaminated with foreign materials. Notably, in many cases, the recalling establishments had received multiple customer complaints before these recalls. Customer complaints for meat and poultry products can often signal adulteration or misbranding issues that trigger regulatory requirements under 9 C.F.R. Part 416 – Sanitation, Part 417 – Hazard Analysis and Critical Control Point (HACCP) Systems, and Part 418 – Recalls. FSIS recommends, but does not require, that an establishment develop a program to receive and process customer complaints.
- On March 8, 2019, FSIS issued draft Guidelines for Industry Response to Customer Complaints to provide reference material on best practices and recommendations on how to receive, investigate and process customer complaints. The new guidelines encompass all types of customer complaints, including quality issues that do not trigger regulatory requirements. The new guidelines recommend also consulting a more narrowly focused related document developed by industry in 2018, Industry Best Practices for Customer Complaints of Foreign Material in Meat and Poultry Products. When the evaluation, investigation, and corrective actions for FSIS regulated products are fully documented and available to FSIS for review upon request under a customer complaint program, the records of the program can be used to fulfill mandatory regulatory requirements.
- The new FSIS guidelines address the following components of a consumer complaint program: Customer Complaint Reporting, Substantiation of the Customer Complaint, Establishment Response to a Customer Complaint (including Establishment Response Plan and Investigation, FSIS Notification, and Corrective Actions), and Documentation of the Customer Complaint. The new guidelines also provide an extensive discussion of 9 C.F.R. § 418.2 (“Notification”), which requires all establishments to report to the agency within 24 hours when they have shipped or received an adulterated USDA-regulated product and that product is in commerce. FSIS stresses that product containing foreign material is adulterated even when a physical food safety hazard is not present. Additionally, the new guidelines clarify when product is “in commerce” and when the 24‑hour time period starts.
- FSIS will respond to public comments received by May 15, 2019 and will update the guideline as necessary.
USDA and FDA Provide Additional Details on Joint Regulation of Cell-Cultured Meat
- As we previously reported, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) in a November 16, 2018 joint press release, announced an agreement on joint regulation of cell-cultured meat. Though the framework was not released at the time, the press release indicated that under the agreement, FDA will oversee “cell collection, cell banks, and cell growth and differentiation. A transition from FDA to USDA oversight will occur during the cell harvest stage. USDA will then oversee the production and labeling of food products derived from the cells of livestock and poultry”. As we noted at the time, the scope of USDA inspection was not addressed and the Agencies agreed that no legislation would be necessary to effectuate the joint agreement.
- On March 7, 2019, USDA and FDA published a “Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species” (the press release can be found here). The agreement provides some indication of expected inspectional burdens on industry – the agreement includes a provision that USDA will “require each establishment that harvests cells cultured from livestock or poultry . . . for the purpose of producing human food required to bear the USDA mark of inspection, processes those cells into such human food products, or packages and labels such products, to obtain a grant of inspection, as required by the FSIS regulations.” In addition, USDA will conduct “inspection in establishments where cells cultured from livestock and poultry subject to the FMIA and PPIA are harvested, processed, packaged or labeled, in accordance with applicable FSIS regulations (including sanitation and physical product inspection, Hazard Analysis and Critical Control Point (HACCP) verification, product testing, and records review), to ensure that resulting products are safe, unadulterated, wholesome and properly labeled.” As FDA will oversee cell collection and the development/maintenance of cell banks up and until the harvesting stage, FDA also will conduct inspections at those facilities to ensure compliance with FDA laws and regulations.
- In contrast, the formal agreement provides no clarity on the statutory basis for USDA regulation. As opposed to the press release in November, which indicated that no legislation would be necessary, the formal agreement indicates that FDA and USDA “will undertake a joint process to identify any changes needed to statutory or regulatory authorities to effectuate” the agreement.
- Keller and Heckman will continue to track the regulation of cell-cultured meat.
FDA Warns of Asbestos Contamination in Certain Cosmetics
- Unlike other product categories regulated by FDA, FDA’s authority over cosmetic products marked in the United States is limited. FDA lacks mandatory recall authority for cosmetics, and manufacturers are not legally required to disclose adverse health effects reported by consumers. Ultimately, companies and individuals who market these products in the U.S. bear the responsibility for the safety and labeling of their products.
- In 2017, FDA become aware of reports of asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers. On Sept. 5, 2017 Justice voluntarily recalled the suspect products, and on December 22, 2017, Claire’s removed a number of products from its stores. In a statement on March 5, 2019, former FDA Commissioner Dr. Scott Gottlieb and Dr. Susan Mayne, Ph.D., Director of the Center for Food Safety and Applied Nutrition explained that after Claire’s withdrew and Justice recalled the suspect products, FDA conducted independent tests to determine if some of these products did, in fact, contain asbestos. Those tests confirmed the presence of asbestos in three of the product samples collected from Claire’s and one of the product samples collected from Justice.
- While suspect Justice products, including the one that tested positive for asbestos were previously recalled from the market, FDA noted that Claire’s has refused to comply with the Agency’s request to recall the products. Because the Agency does not have authority to mandate a recall, FDA issued a Safety Alert, warning consumers to not use three of Claire’s products because they tested positive for asbestos. In essence, the Agency utilized the statement in this case to publicly announce their alleged safety concerns with the products and to point out that Claire’s had failed to comply with FDA’s request. While not a recall, this statement represents a powerful tool for the Agency to communicate concerns with respect to cosmetics.
