In Light of 2018 Farm Bill, FDA Issues Statement on Use of CBD in Food; Completes Evaluation of 3 Hemp-Related GRASNs

  • The Agriculture Improvement Act (also known as “the 2018 Farm Bill”) was signed into law on December 20, 2018.  Among other things, the law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis (e.g., CBD) with extremely low (less than 0.3% on a dry weight basis) concentrations of THC.  The changes include removing hemp from the Controlled Substances Act, which means it will no longer be an illegal substance under federal law.
  • However, as previously reported on this blog, the 2018 Farm Bill does not affect FDA’s authority to regulate CBD or other hemp products, or change the regulatory requirements for such materials in FDA-regulated products like food, dietary supplements, cosmetics, or drugs.  Indeed, Congress explicitly preserved FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act and section 351 of the Public Health Service Act.  FDA released a statement clarifying their position on the use of cannabis or cannabis-derived compounds in food and dietary supplements.  In sum, it is still illegal to sell a food or dietary supplement that contains added CBD or THC in interstate commerce.
  • In their statement, FDA acknowledged that there is significant public interest in this area and FDA plans to evaluate whether they should issue a regulation allowing the use of a drug ingredient in food or dietary supplements.  FDA intends to hold a public meeting for stakeholders and based on input provided at the meeting, FDA will consider the lawful pathways for such products to be marketed, and how FDA can make those pathways more predictable and efficient.
  • Relatedly, FDA also announced that the agency had completed their evaluation of three GRASNs related to hulled hemp seeds (GRN 765), hemp seed protein (GRN 771), and hemp seed oil (GRN 778).  FDA had no questions regarding the companies’ conclusions that the uses of such products are safe.  Thus, the products can be legally marketed in human foods.  As mentioned by FDA, some substances that are derived from hemp may not contain CBD or THC (or contain de minimis levels), such as those substances at the focus of the GRASNs.  Thus, their addition to foods do not raise the same issues as the addition of substances that contain CBD or THC.

National Bioengineered Food Disclosure Standard Final Rule Released

  • After much anticipation, the Agricultural Marketing Service (AMS) has released the final rule establishing the national mandatory bioengineered (BE) food disclosure standard. The rule is scheduled to be published on December 21, 2018 in the Federal Register. As previously reported on this blog, the proposed rule was published on May 4, 2018 and approximately 14,000 comments were received by the end of the comment period. The final rule includes a number of significant provisions related to applicability, disclosure requirements, administrative provisions, and compliance dates.
  • Keller and Heckman will release a comprehensive client alert on the final rule within the week, so while this blog cannot cover all areas of the final rule, below are some of the issues of interest:
    • Highly refined ingredients, detectability, and voluntary disclosure: the rule’s definition of “bioengineered food” specifically excludes foods where modified genetic material is not detectable and includes provisions for how regulated entities can use records to demonstrate that modified genetic material is not detectable, which would remove those foods from the requirement to disclose. However, if an entity wishes to disclose a food made with ingredients derived from a BE source, where the genetic material does not have detectable modified genetic material, the rule allows for entities to make a voluntary disclosure, creating a voluntary “derived from bioengineering” disclosure.
    • List of Bioengineered Foods: the final rule adopts one single “List of Bioengineered Foods” to identify the crops or foods that are bioengineered to help regulated entities determine whether a food must bear a BE disclosure. Canola, corn, soybean, and sugarbeet, among others, are included. Updates to the List will be done through rulemaking on an annual basis.
    • Exemptions from disclosure, including a threshold allowance and incidental additives: the final rule adopts a threshold for inadvertent or technically unavoidable presence of bioengineered substances of up to 5% for each ingredient, with no allowance for any BE presence that is intentional. Moreover, the final rule also exempts incidental additives that are present in food at an insignificant level and do not have any technical or functional effect in the food.
    • 4 disclosure options: In addition to the text (“bioengineered food” or “contains a bioengineered food ingredient”), symbol, and electronic disclosure, USDA adopted an additional text message disclosure option. The chosen symbol is one of the symbols USDA filed with the U.S. Patent and Trademark Office after the comment period ended for the proposed rule
    • Implementation and compliance dates: the final rule establishes implementation dates of January 1, 2020 for entities other than small food manufacturers and January 1, 2021 for small food manufacturers; entities are to begin implementing the standard no later than those dates. The final rule also establishes a mandatory compliance date, January 1, 2022, for all regulated entities, and a voluntary compliance period, where entities can use labels compliant with preempted State labeling laws, which ends on December 31, 2021.
  • In addition to the client alert, Keller and Heckman is planning to present a webinar on the final rule in the coming weeks. Stay tuned!

The Daily Intake is taking a holiday hiatus and will return on January 2, 2019.  We wish you a joyous holiday season and a happy new year. 

 

FDA Issues Technical Amendments to Final Nutrition and Supplement Facts Rule

  • FDA will publish in the December 21, 2018 Federal Register a final rule that makes technical amendments to its 2016 final rule on Nutrition and Supplement Facts labeling.  The amendments, which are not substantive in nature, affect both 21 C.F.R. 101.9 (“Nutrition labeling of food”) and 21 C.F.R. 101.36 (“Nutrition labeling of dietary supplements”).
  • While there are many technical amendments addressed in the rule, some highlights include:
    • Correcting cross references to other paragraphs in the regulations, spelling errors, and formatting errors;
    • Providing new sample labels that fully comply with the new regulations (e.g., one sample label omitted information on the number of servings per container and serving size) and new sample labels to replace those that had appeared blurry;
    • Reordering the vitamin and minerals listed in the table at Section 101.9(c)(8)(iv) so that the mandatory nutrients (i.e., vitamin D, calcium, iron, and potassium) appear first in the list; and
    • Removing language from Section 101.36(e) stating that calorie information in Supplement Facts boxes needs to be bolded text and in larger type.
  • Because the amendments are technical in nature, there is no comment period, and the final rule becomes effective immediately on December 21, 2018.

Stakeholder Groups Release Strategy for Antibiotic Stewardship in Food Animal Production

  • As previously covered on this blog, for years, FDA, USDA, the European Food Safety Authority (EFSA) and stakeholder groups have grappled with how to address public health concerns about the use of antibiotics to promote growth or feed efficiency in food-producing animals. At the federal level in the US, FDA has outlined its strategy to phase out the use of medically important antimicrobials in food animals for production purposes in FDA’s Guidance for Industry #213.   Most recently, in a Statement from Commissioner Gottlieb, FDA announced its 2017 report on antimicrobials sold or distributed for use in food-producing animals. Among other findings, the report highlights a 33 percent decline between 2016 and 2017 in domestic sales of antimicrobials intended for use in food-producing animals.
  • In response to the continued issues surrounding antimicrobial resistance, the Pew Charitable Trusts and Farm Foundation, in partnership with organizations, such as McDonald’s Corporation, the National Milk Producers Federation, the National Pork Board, etc., released a new framework for antibiotic stewardship on farms. The voluntary framework defines core components of antibiotic stewardship programs, which are based on veterinary guidance and partnership, disease prevention strategies, and optimal treatment approaches, as well as effective recordkeeping and a culture of continuous improvement. The framework is meant to apply across the animal supply chain. In an article accompanying the framework, Pew noted that the framework is modeled after the Centers for Disease Control’s history of brokering consensus around the core elements of successful antibiotic stewardship programs in healthcare settings.
  • Industry will have to adopt the principles outlined in the framework for the program to be effective. Pew notes that the “actionable framework will enable the full range of stakeholders to adopt and implement best practices as part of existing and future antibiotic stewardship programs.” We will continue to monitor whether this voluntary, industry-driven framework proves effective in reducing the use of antimicrobials in food animals.

Fishy Business: Seafood Fraud in New York State

  • As previously reported on this blog, the seafood industry has continued to deal with the issue of seafood fraud, which includes the substitution of cheaper species for more expensive ones. In December 2016, the National Oceanic and Atmospheric Administration published a final rule establishing a “Seafood Import Monitoring Program,” which included permitting, reporting and recordkeeping procedures related to the importation of certain fish and fish products.  Compliance for most species was effective on January 1, 2018, and shrimp and abalone compliance will be mandatory by December 31, 2018.
  • Despite the new federal reporting and recordkeeping requirements, New York Attorney General released a report on December 14, 2018 revealing “rampant mislabeling” of fish in New York state.  From late 2017 through 2018, the New York State Office of the Attorney General investigated seafood fraud at retain supermarkets in the state. The results revealed that more than one in four seafood purchases were mislabeled. Specifically, consumers who bought lemon sole, red snapper and grouper were more likely to receive an entirely different fish. Substitutes were typically cheaper, less desirable species than the chosen species.  Ultimately, the report concludes, “solving the seafood fraud problems requires industry-wide reforms, at all stages of the supply chain” and offers best practices to industry.
  • We suspect that class actions will follow the New York Attorney General’s report and we will continue to monitor the important issue of food fraud and its impact on the food industry.

FSIS Announces Move from Pulsed-Field Gel Electrophoresis to Whole Genome Sequencing for Analyzing Shiga Toxin-Producing E. coli (STEC) and Salmonella Isolates

 

  • Whole genome sequencing (WGS) determines the order of all of the DNA building blocks (nucleotides) in an organism’s entire genome in a single laboratory process.  A comparison of the DNA sequence of an isolated bacterial pathogen to the sequences from other samples in a DNA database can pinpoint the source of a foodborne disease outbreak.  The analytical tools for WGS have become increasingly accurate, easy, and affordable such that health agencies have moved to WGS as the preferred tool for investigating foodborne illnesses from Listeria, Salmonella, and pathogenic strains of Escherichia coli, including E. coli O157:H7.

 

  • As reported here, the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) held a meeting to discuss the state of the art and FSIS’s plans for collecting and analyzing WGS data for bacteria isolated from official samples.  For fiscal year 2017, all bacterial pathogens isolated under FSIS testing programs have been analyzed in parallel using both pulsed-field gel electrophoresis (PFGE) analysis and WGS.  A FSIS Constituent Update (December 14, 2018) announces that FSIS will suspend routine PFGE analysis and transition to using only WGS for Shiga toxin-producing E. coli (STEC), effecting January 15, 2019, and for Salmonella isolates, effective March 15, 2019.

 

  • FSIS inspects almost 6,500 establishments daily and collects a very large volume of microbial samples on a routine basis.  Under the FSIS Microbial Testing Program for Ready-To-Eat (RTE) Meat and Poultry in 2017, for example, FSIS collected and analyzed 6,892 RTE food samples for Salmonella and Listeria monocytogenes (Lm) and analyzed 4,614 samples from food-contact surfaces for Lm.  As the technology expands, WSG will become an increasingly valuable tool for quickly tracing diseases to their source and perhaps someday identifying pathogens in the environment early enough to prevent contamination of food altogether.

 

FDA and CDC Identify One Source of E. Coli Contaminated Romaine

  • As discussed in this blog two and three weeks ago, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have been investigating a multistate outbreak of E. coli O157:H7 illnesses that were likely linked to romaine lettuce.  On November 20, CDC advised consumers, retailers, and restaurants not to eat, sell, or serve any romaine lettuce until the source of the outbreak was better understood.
  • On November 26, FDA announced that it had narrowed down the traceback to romaine lettuce grown in the central coast growing regions of northern and central California.  FDA also said that lettuce known to be grown outside of this region is safe to eat, sell, or serve.  On the same date, the United Fresh Produce Association issued a press release confirming that a number of grower shippers had negotiated an agreement with FDA.  Under the agreement, supported by multiple produce associations, including United Fresh Produce Association, grower shippers agreed to label their romaine products with the region where they were grown and the approximate harvest date.
  • On December 13, FDA provided an update on the outbreak.  The onset of the last of the 59 confirmed illnesses, with 23 hospitalized, was November 16.  FDA and CDC announced that they have narrowed down the source of the outbreak to “Monterey, San Benito, and Santa Barbara counties in California. Romaine lettuce from outside those counties need not be avoided. Consumers may notice that romaine lettuce is beginning to be available in stores with new labeling. Additionally, romaine from Ventura, San Luis Obispo, and Santa Cruz counties harvested after November 23, 2018 should be labeled with harvest area and harvest date, allowing it to be distinguished from romaine lettuce that should be avoided.”  FDA and CDC also confirmed that Hydroponically- and greenhouse-grown romaine are likely safe.
  • Of particular note, FDA and CDC confirmed via whole genome sequencing a sample from Adam Bros. Farming Inc. with the same strain of E. Coli as the outbreak.  Adam Bros. has not shipped romaine since November 20 and experts are working with the farm to identify the source of the contamination and safety measures to take before the next growing season.
    • Adam Bros. is likely not the only source of the contamination.  Per the FDA press release, “[t]he finding on this farm, however, does not explain all illnesses. The FDA’s traceback activities of romaine lettuce will continue as FDA works to determine what commonalities this farm may have with other farms and areas that are being assessed as part of the investigation.”

Contrary to Popular Reports, Farm Bill Will Not Affect FDA Status of CBD

  • Media outlets are reporting that a Farm Bill provision removing industrial hemp (Cannabis sativa L.) from Schedule I of the Controlled Substances Act will change the FDA status of cannabidiol (CBD) in foods.  However, the relevant provisions under Subtitle G (“Hemp Production”) affect only the Drug Enforcement Administration’s (DEA’s) authority over hemp farming and allow states to exercise authority over industrial hemp production.
  • The  2018 Farm Bill, which passed the Senate on December 11 and the House on December 12, does not affect FDA’s authority to regulate CBD or other hemp products, or change the regulatory requirements for such materials in FDA-regulated products like food, dietary supplements, cosmetics, or drugs.  In fact, Section 297D, paragraph (c)(1) (“Regulations and Guidelines; Effect on Other Law”) states “nothing in this subtitle shall affect or modify the Federal Food, Drug, and Cosmetic Act.”
  • FDA has stated on its “FDA and Marijuana: Questions and Answers” website that CBD is not permitted in food (including dietary supplements) and has sent warning letters to companies marketing CBD products for food uses.  Thus, companies that wish to market CBD-containing foods, dietary supplements, or cosmetics are still at risk of FDA enforcement action unless they can develop an appropriate regulatory status for CBD in those products.  Through its regulatory procedures, in June 2018, FDA approved Epidiolex, a drug product containing CBD as the active ingredient, as a treatment certain forms of epilepsy.

Second Circuit Remands “Whole Grain” Cheez-It Lawsuit

  • The United States Court of Appeals for the Second Circuit held that a New York district court erred in ruling that labeling Kellogg’s Cheez-It crackers as “whole grain” was not misleading, despite the fact that the snacks were primarily made from enriched white flour.  Thus, the Second Circuit vacated the decision and remanded the case for further proceedings.
  • In 2016, Kristen Mantikas and two co-plaintiffs filed a lawsuit against Cheez-It manufacturer Kellogg Co., alleging the “whole grain” Cheez-It labels violated New York and California’s consumer protection laws.  Plaintiffs sought declaratory and injunctive relief, as well as monetary damages, on behalf of a putative class of all persons residing in the U.S. and its territories who purchased whole grain Cheez-Its since May 19, 2010.  Plaintiffs argued they purchased the “whole grain” Cheez-Its because the “whole grain” label claims caused them to believe that the grain content of the crackers was predominantly whole grain.  However, U.S. District Judge Sandra J. Feurstein dismissed the case in 2017 and adopted Kellogg’s argument that the Cheez-It labeling was not misleading.  Judge Feurstein stated that the ingredient list clearly declared whole grain flour as the second or third ingredient, whereas enriched white flour – the most predominant ingredient in the cracker – was declared first.  Further, she stated that the Nutrition Facts Panel showed that only five or eights grams, out of a 29 gram serving size, were whole grain.
  • However, a three-judge panel sitting for the Second Circuit rejected that reasoning by stating it does not matter if “the side panel of the packaging discloses further detail about the product’s ingredients. […] reasonable consumers expect that the ingredient list contains more detailed information about the product that confirms other representations of the packaging.” The Second Circuit concluded that a reasonable consumer should not be expected to consult the Nutrition Facts Panel to correct misleading information set forth in large bold type on the front of the box.
  • The Second Circuit went on to rebuke Kellogg for its argument that as long as all of the details of a product are disclosed somewhere on the label, the product is not misleading.  “Moreover, the rule that Defendant contends emerges from these district court decisions [cited in its appellate brief]—that, as a matter of law, it is not misleading to state that a product is made with a specified ingredient if that ingredient is in fact present—would validate highly deceptive advertising and labeling. Such a rule would permit Defendant to lead consumers to believe its Cheez‐Its were made of whole grain so long as the crackers contained an iota of whole grain, along with 99.999% white flour. Such a rule would validate highly deceptive marketing.”

Mixed Reactions to Final Rule on School Meal Flexibilities

  • As previously posted on this blog on November 30, 2017, the U.S. Department of Agriculture (USDA) announced temporary exemptions to some of the rigid nutrition standards for school meals established by the Healthy, Hunger-Free Kids Act in 2010 and published an interim final rule, titled the “School Meal Flexibility Rule,” that would make some of those changes permanent.
  • USDA announced that it will publish a final rule in the Federal Register tomorrow, December 12, that will codify three menu planning flexibilities that were temporarily established by the interim final rule. (A pre-publication, unofficial version of the rule can be viewed here.) The three flexibilities are described below.
    • Flavored, low-fat (1%) milk will be included under the milk option in the National School Lunch and Breakfast Programs and will be allowed in the Special Milk Program for Children and in the Child and Adult Care Food Program for participants ages 6 and older.
    • Half of the weekly grains in the school lunch and breakfast menu must be whole grain-rich. (Previously, 100% had to whole grain unless an exemption was obtained.)
    • Schools in the lunch and breakfast program will have more time to reduce sodium levels and the final target will be lower than previously established.
  • Response to the final rule for school meals has been mixed. Some of the reactions are shown below.
    • “We hope all schools reject this regulation and continue their commitment to serve healthier foods on our kids’ plates.” American Heart Association
    • “[USDA’s] final rule strikes a healthy balance. Schools will continue to meet strong nutrition standards but can prepare meals that appeal to a wide range of students…Despite extensive efforts to boost consumption of healthy school meals, student lunch participation continues to gradually decline, as nearly 2 million fewer students choose school lunch each day since updated nutrition standards took effect.” The School Nutrition Association
    • “The new rule is good news for schools, students and American dairy farmers.” The National Milk Producers Federation
    • “[USDA’s] final rule on school nutrition standards runs counter to accepted science about quality school nutrition. By rolling back previous standards that were designed to limit students’ sodium intake and promote the consumption of healthier whole grains, USDA is threatening the progress we’ve made toward improving nutrition in schools.” Rep. Robert C. “Bobby” Scott (VA), ranking Democrat on the House Education Committee, as quoted in The Washington Post
  • In a press release concerning the final rule, Agriculture Secretary Sonny Perdue noted that schools have faced challenges serving meals that both are appetizing and meet nutritional standards. “If kids are not eating what is being served, they are not benefiting, and food is being wasted,” he added.
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