• As our readers are aware, in May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulation. The final rules regarding nutrition labeling established a definition for the term “dietary fiber.” In March 2018, FDA published final guidance on dietary fiber that communicated the Agency’s revised standard of review of the scientific evidence that shows non-digestible carbohydrates (NDCs) have a beneficial physiological effect on human health. Then, as previously reported on this blog, FDA announced on June 15, 2018, that it had responded to five citizen petitions requesting that additional NDCs be added to the definition of “dietary fiber,” including one for isomaltooligosaccharides (IMOs), which the Agency denied. (FDA did grant fiber status to three of the substances that were the subject of those Citizen Petitions.)
  • FDA received a Citizen Petition on March 4, 2019, from Top Health Ingredients, Inc., requesting that IMO be included within the list of dietary fibers identified in 21 C.F.R. §101.9(c)(6)(i). The petition identifies IMOs as glucose oligomers that contain D-(1,6)-linkages and cites two requirements for including IMO within the list of  “dietary fibers.
    • The food substance must be composed of isolated or synthetic non-digestible carbohydrates with 3 or more monomeric units and
    • The food substance must be the subject of a petition submitted to FDA under 21 C.F.R. §10.30 demonstrating that such carbohydrates have a physiological effect that is beneficial to human health.
  • The petition continues to explain how IMO satisfies both of those requirements. The beneficial physiological effects cited are reductions in blood cholesterol concentrations and improved laxation. More information on the petition, including how to comment, can be found here.

 

  • In 2014, the Food and Drug Administration (FDA) began random sampling and testing of a variety of commodities from domestic and foreign sources to learn more about the prevalence of disease-causing bacteria.  The first commodities sampled were sprouts, whole fresh avocados, and raw milk cheese (aged 60 days), followed by cucumbers and hot peppers.  Each commodity was tested for Salmonella, Listeria monocytogenes, and E. coli O157:H7.  Hot peppers were also tested for Shiga-toxin producing E. coli (STEC).  Summary Reports are available for FY16-17 Hot Peppers, FY14-16 Whole Fresh Avocados, FY14-16 Raw Milk Cheese Aged 60 Days, and FY14-16 Sprouts.  Interim Data are available for FY16 Cucumbers.  As previously reported on this blog, Salmonella was detected in 15 of the 1,050 cucumber samples, while Listeria monocytogenes and E. coli O157:H7 were not detected in any of the samples.

 

  • On April 4, 2019, FDA released data from testing of 747 fresh herb samples (basil, parsley, and cilantro) and 526 processed avocado or guacamole samples for bacterial pathogens.  Nine fresh herb samples tested positive for Salmonella (4 domestic, 5 import) and six tested positive for STEC, which further testing showed were not capable of causing severe illness.  E. coli O157:H7 was not detected in any of the fresh herb samples.  Cyclospora cayetanensis, which was tested only in herbs harvested in summer months, was detected in two of 141 samples of domestically grown fresh herbs tested and four of 74 samples of imported fresh herbs.  Of the processed avocado or guacamole samples, 11 tested positive for Listeria monocytogenes and two tested positive for Salmonella.

 

  • FDA uses data from the microbial surveillance sampling program to identify potential vulnerabilities and ways to enhance the food safety system.  Follow up inspections or corrective actions may be taken when a sample tests positive for a pathogen.  For example, the detection of Listeria monocytogenes-positive samples of avocado pulp resulted in FDA refusing entry of avocados from lots associated with the positive samples and FDA put the responsible firms and their product on Import Alert 99-23.  While FDA builds this important database, foodborne disease outbreaks continue to occur on a regular basis.  On April 5, 2019, the Centers for Disease Control and Prevention (CDC) posted an Investigation Notice of a new multistate outbreak of Shiga toxin-producing Escherichia coli (E. coli) O103 infections of 72 people, with 8 hospitalizations and 0 deaths reported from March 2 – March 29, 2019.  No specific food item, grocery store, or restaurant chain has been identified as the source of infections.
  • In November 2018, FDA announced that it had tested 26 kratom products with “disturbingly” high heavy metal levels.  Also known as Mitragyna speciose, kratom grows naturally in Southeast Asia and has opioid-like properties.  The Daily Intake blogged on the topic here.
  • Besides concerns regarding kratom’s opioid-like properties, FDA also has taken action and issued its only mandatory recall order due to Salmonella contamination.
  • On April 3, FDA released a summary of the heavy metal testing – now on 30 products.  In his comment accompanying the data release, Dr. Scott Gottlieb, the outgoing Commissioner of FDA, noted that FDA has “been attempting to work with the companies whose products were found to contain high levels of heavy metals”
  • FDA’s attention on kratom brings to the fore important reminders for all food and dietary supplement producers regarding raw materials testing, supplier verification and validation, and FDA recall authority.
  • Given the increased prevalence of plant biotechnology to develop innovative foods, FDA is reminding industry of its voluntary consultation program to ensure the safety of and public confidence in plant biotechnology-derived foods.  FDA describes “plant biotechnology” as “certain methods scientists can use to introduce new traits or characteristics to a plant.”
  • FDA has assisted in 184 voluntary consultations through this program since its introduction in 1995.  In encouraging industry to participate in the program, FDA provided the recent example of Calyxt, Inc., which consulted with FDA on the safety and nutritional profile of its FAD2KO soybean that is gene-edited to be high in oleic acid.
  • Concurrently with its voluntary consultation program statement, FDA issued revised Guidance for Industry on the Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants.  The guidance states that, given the issuance in December 2018 of USDA’s National Bioengineered Food Disclosure Standard (NBFDS) implementing regulations, FDA is “reviewing this draft guidance to consider what additional or new recommendations may be needed for the kinds of products or statements, including claims of non-GE [genetically engineered] content, that are not covered by the NBFDS.”  In the meantime, the guidance continues to describe how to make voluntary claims on biotechnology that use proper terminology so as to be truthful and not misleading.
  • Interest in products derived from cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD) has been high for the past couple of years and only increased when Congress passed the 2018 Farm Bill in December 2018.  Among other things, the law established a category for “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 included removing “hemp” from the Controlled Substances Act, which means it will no longer be an illegal substance under federal law.
  • However, FDA’s authority to regulate CBD or other hemp products did not change with the passage of the 2018 Farm Bill and significant public interest in this area has pushed the Agency to explain its current approach to these products and its intended next steps.  FDA issued a statement in December 2018 repeating its long-held position that it is illegal to use CBD in food and supplement products because CBD is an active ingredient in an approved drug product (Epidiolex) and has been the subject of publicly-disclosed clinical investigations.  Further confusing matters, however, outgoing FDA Commissioner Scott Gottlieb announced during testimony to the Senate Appropriations Committee on March 28, 2019 that FDA was exercising “enforcement discretion” and not taking action against CBD-containing products unless they make “over-the-line claims” (as reported here and here).
  • On April 2, 2019, FDA released a statement from Commissioner Gottlieb that announces several next steps:
    • A public hearing will be held on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety.
    • The Agency will create a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD and other cannabis-derived ingredients to be lawfully marketed, including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.
    • The Agency will update its webpage with answers to frequently asked questions on this topic to help members of the public understand how the FDA’s requirements apply to these products.
  • In addition to the above, FDA announced that it has issued warning letters to three companies in response to their making unsubstantiated claims about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval.
  • Arkansas recently joined the states that prohibit marketing a product as “meat” if it is not derived from livestock or poultry. Arkansas Governor Asa Hutchinson signed HB 1407, titled, “To Require Truth in Labeling of Agriculture Product Are Edible by Humans,” into law (Act 501) last month. Significantly, Arkansas Act 501, also bans manufacturers from marketing a product as rice if it doesn’t contain rice. “Rice” is defined as “the whole, broken, or ground kernels or by-products obtained from the species Oryza Sativa L. or Oryza glaverrima, or wild rice, which is obtained from one of the four species of grasses from the genus Zizania or Proteresia.” (For more information, see our blog on Arkansas’ resolution calling for a standard for rice.)
  • Readers of our blog are aware of the ongoing cell-cultured and plant-based meat labeling debate—both at the federal and the state level and the emergence of plant-based meat products. Missouri was the first state to limit the use of the term “meat” to products derived from livestock or poultry (see Mo. Rev. Stat. § 265.494(7)). Similar laws have since been passed by Wyoming (SF0068 was signed by the governor on Feb. 26, 2019) and South Dakota (SB68 was signed by the governor on March 18, 2019). Other states that are currently considering legislation that would prohibit marketing a product that is not derived from livestock or poultry as meat include Arizona, Nebraska, Tennessee, Colorado, and Virginia.
  • The Arkansas Truth in Labeling Law imposes a $1,000 fine for each violation. The new law will take effect 90 days after the 2019 session ends. Arkansas produces 49% of the rice supply in the U.S. and in 2018, 1.4 million acres of rice were harvested in the state (University of Arkansas Div. of Agriculture). We will continue to monitor and report on regulatory activity in this area.

 Kavanaugh, Roberts In Crossfire of Battle Over ‘Auer’ (subscription to Law360 required)

  • The U.S. Supreme Court heard arguments on March 27, 2019 about whether to overturn the principle of judicial review of federal agency actions that requires a federal court to yield to an agency’s interpretation of an ambiguous regulation that the agency has promulgated.  Under this policy, known as ‘Auer deference’ from the 1997 case Auer v. Robbins, a court must yield to an agency’s interpretation of its own unclear regulation unless the court finds that the interpretation is “plainly erroneous or inconsistent with the regulation.”
  • Auer deference was the basis for successful defendant motions to dismiss over the past year in a number of class actions concerning ‘No Sugar Added’ claims on 100% juices.  We reported, for example, on the U.S. District Court for the Central District of California granting a motion for summary judgment in favor of Odwalla, in Wilson v. Odwalla Inc. et al. (Case Number 2:17-cv-02763) based on the Food and Drug Administration’s (FDA) interpretation of paragraph (c)(2)(iv) of 21 CFR 101.60 (“Nutrient content claims for the calorie content of foods”) as permitting juice with no added sugar to be considered a substitute for juice with added sugar and similar sugar-sweetened beverages.
  • Based on the Justices’ comments in the recent hearing, it is not clear if Auer deference will be intact at the end of June, by which time a ruling is expected.  Many food product labels could face renewed attacks under state consumer protection and false advertising laws if courts are no longer bound by FDA’s interpretation of ambiguous regulatory requirements, including the use of ‘no sugar added” under the regulation on nutrient content claims.

 

  • The FSMA final Produce Safety Rule was published on November 27, 2015 (80 FR 74353) and establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce. Our detailed summary of the rule is available here.
  • In a recently released guidance for industry, “Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds,” the Agency announced it will exercise enforcement discretion for Produce Safety Rule requirements for specific commodities: hops, wine grapes, pulse crops and almonds. After receiving input from industry groups and conducting its own analysis, the Agency concluded that these commodities have unique production circumstances and intended uses which reduce the likelihood for foodborne pathogens to pose a risk.
  • Ultimately, this announcement of enforcement discretion means that the Agency will not expect entities growing, harvesting, packing, or holding these commodities to meet any of the Produce Safety Regulation requirements with respect to these commodities. However, in the guidance, the Agency noted that it may consider pursuing rulemaking to address the unique circumstances of each commodity and may revise the exercise of enforcement discretion if, for example, new information becomes available regarding safety concerns associated with the production and consumption of these commodities.
  • A California plaintiff, who used Roundup on his 56-acre Santa Rosa property and alleged glyphosate caused his non-Hodgkin lymphoma, has been awarded $80 million by a jury in the U.S. District Court for the Northern District of California.  The docket of the case, Hardeman v. Monsanto Co. et al., is available here (subscription required).  This verdict is the second significant glyphosate judgment against Bayer-owned Monsanto, following on the August 2018 verdict that awarded a former school groundskeeper $289 million (later reduced to $78 million by a judge reviewing the case). 
  • In a statement after the verdict, Bayer expressed disappointment but stressed that the science supports that its glyphosate products are not carcinogenic.  In particular, Bayer quoted a recent Health Canada statement that “no pesticide regulatory authority in the world currently considers glyphosate to be a cancer risk to humans at the levels at which humans are currently exposed.”
  •  Hundreds of additional cases are forthcoming, including a federal multi-district litigation scheduled to begin at the U.S. District Court for the Northern District of California on May 20, 2019. 

 

  • On March 12, 2019, snack bar producer, KIND, submitted a Citizen Petition to the FDA asking the agency to update the framework for regulating nutrient content claims (NCCs). In sum, the petition requests that FDA consider the overall quality of the food, rather than just the quantity of a certain nutrient when regulating nutritional claims on labeling. KIND argued that the NCC regulatory framework is outdated, does not reflect key principles of today’s evidence-based dietary guidance, and is ineffective in helping consumers make appropriate dietary choices.  Instead, KIND insisted the framework allows the use of NCCs that “mislead consumers to believe that the products bearing such claims provide useful evidence-based dietary value, when they do not.”
  • Through the Citizen Petition, KIND requested FDA take the following actions:
    • “Revise its nutrient content claim regulations to only allow a food to bear a nutrient content claim highlighting the presence or absence of a nutrient if the food contains a meaningful amount of at least one health-promoting food, such as: vegetables, fruits (especially whole fruits), whole grains, legumes, nuts, and seeds, which are recommended in the most recent Dietary Guidelines of Americans.”
    • “Amend 21 C.F.R. 101.13(h) to include disclosure levels for added sugar and trans fat and to remove disclosure levels for total fat and cholesterol.”
    • “Revise its nutrient content claim regulations to disqualify foods, other than meal products or main dish products, that contribute more than 25 percent of the daily value for saturated fat, sodium, or added sugar or more than 1.0 gram of trans fat from bearing nutrient content claims.”
    • “Revise its nutrient content claim regulations to require that, where a nutrient content claim is based on a nutrient that has been added to a food, such fortification is in accordance with FDA’s policy on fortification of foods in 21 C.F.R. 104.20.”
  • As stated, KIND argued the current framework allows for the use of claims based solely on the quantity of nutrients, without any consideration for the quality of the food.  KIND provided the following example in support: “[F]or most nutrients, a food can bear a “good source” or “excellent source” claim, regardless of whether the highlighted nutrient is naturally-occurring or was added through fortification, and regardless of whether the food is otherwise nutrient-dense. This means that a pack of gummy bears, fortified with inulin (a dietary fiber), could be labeled as a “good source of fiber” so long as the gummy bears contain about 3 grams of fiber – i.e., 10 percent of the daily value for fiber – per reference amount customarily consumed (RACC).”
  • Longtime readers may recall that this is not the first time KIND has petitioned FDA. In December 2015, KIND submitted a Citizen Petition that requested FDA reevaluate its NCC regulations with specific focus on those related to the term “healthy.” KIND argued that FDA’s “healthy” definition — which has remained the same since 1994 — is outdated and fails to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods. KIND submitted the Citizen Petition in response to an FDA Warning Letter, which requested the company remove the word “healthy” from its packaging. However, by May 2016, FDA reversed their decision and KIND was allowed to continue using “healthy” on its products.