• On January 13, 2020, Kansas joined the growing number of states that have introduced or enacted legislation that prohibit the marketing of a product as “meat” if it is not derived from livestock or poultry. HB 2437 would amend the Kansas Food, Drug, and Cosmetic Act to prohibit the use of identifiable meat terms on labels or in advertisements of meat analogs without either an accompanying disclaimer that the product does not contain meat or the inclusion of the word “imitation” before the name of the meat food product being imitated.
  • If enacted, a product would be deemed misbranded if labeled or advertised with any of the following terms but without a disclaimer or “imitation” qualifier: meat, beef, pork, poultry, chicken, turkey, lamb, goat, jerky, steak, hamburger, burger, ribs, roast, bacon, bratwurst, hot dog, ham, sausage, tenderloin, wings, breast and other terms for food that contain any meat, meat food product, poultry product or poultry food product.
  • HB 2437 was referred to the Kansas Legislature’s Committee on Agriculture, which held a hearing about the bill on January 23. The bill was introduced by State Representative Ron Highland with the support of the Kansas Livestock Association.
  • As our readers are aware, since 2018, 26 states have introduced similar labeling bills, many of which have been challenged in court. For instance, Mississippi, Missouri, and Arkansas have all faced legal battles over their respective plant-based meat labeling laws. Should HB 2437 become law, it is possible Kansas may find itself facing similar challenges.

At the end of 2019, the Chinese State Administration of Market Regulation (SAMR) and the National Health Commission (NHC) proposed significant changes to two food labeling documents for public comments:

Both documents are mandatory for the labeling of prepackaged food produced in and exported to China. It should be noted that the proposed requirements by SAMR and NHC in the drafts do not appear to be fully aligned. For instance, SAMR’s Draft Measures require that a separate item “Food Additive” shall be made available in the ingredient list if the food uses a sweetener, preservative, color, emulsifier, or thickener; however, this is not required under the NHC’s Draft Standard. Therefore, further coordination between SAMR and NHC is expected to eliminate contradictory requirements like this and provide regulatory clarity to the industry.

SAMR and NHC have appeared to tighten certain labeling requirements, particularly ones that have involved past consumer complaints, for example:

  • NHC in the Draft Standard introduces new requirements for “negative claims,” e.g., “free of XXX,” “does not contain XXX,” or words with the similar meaning are prohibited if the substances are not permissible for use by pertaining regulations and standards. The claim “Non-GMO” is another example of a banned claim even if the food does not use any GMO ingredient.
  • SAMR in its Draft Measures proposes different rules of application for labeling information that is mandatorily and required by law versus one that is voluntarily declared by the manufacturer. Specifically, the information on the food package, other than the labeling information mandated by China, is subject to additional requirements set forth in the Advertising Law, Anti-unfair Competition Law and other regulations. For instance, if one wishes to claim on the label that the product is ranked the No. 1 organic milk in China, proper assessment and substantiation of such claim must be done in advance, not only based upon the food labeling legislation, but other applicable rules, e.g., advertising requirements.

Keller and Heckman attorneys have prepared a new China Regulatory Matters (CRMs) newsletter examining further details of the above two Drafts which can be found at Are You Ready for China’s New Food Labeling Requirements? Please stay tuned to the developments of the food labeling requirements in China by subscribing to our CRMs.

Buyers Claim Coke’s Tea Not Honest About Sugar Content (subscription to Law360 required)

  • A proposed nationwide class of consumers who purchased the Honest brand of teas has sued the Coca-Cola company in New York federal court under various state laws for consumer protection, misrepresentation, breach of express and implied warranty, fraud, and unjust enrichment.  The plaintiffs allege to have purchased the teas believing the beverages were lower in calories based on front-of-label claims for “Just a Tad Sweet.”  According to the complaint, the products contain sugar as the second most predominate ingredient and are not “a tad sweet” or low in sugar.
  • As we reported last week, the “Just a Tad Sweet” claim was noted in a January 9, 2020 letter sent by the Center for Science in the Public Interest (CSPI) to the Center for Food Safety and Applied Nutrition (CFSAN) at FDA, urging the Agency to “take immediate enforcement action to prevent unauthorized implied ‘low sugar’ and ‘reduced sugar’ claims.  According to CSPI, and as alleged in the proposed class action against Coca-Cola, claims such as this expressly or implicitly characterize the level of sugar and are therefore prohibited under federal law because “low sugar” is not a defined or permitted nutrient content claim.
  • It is yet to be seen how Coca-Cola will respond.  In a recently settled class action lawsuit over use of the label claims “lightly sweetened,” “healthy,” “nutritious,” and “wholesome,” on select cereals, Kellogg stated that it had never advertised the cereals as “low sugar” or “reduced sugar,” and that the sugar content was clearly listed on each product’s Nutrition Facts Panel but settled the class action lawsuit for $20 million.
  • On December 12, 2019, the Food and Drug Administration (FDA), in conjunction with the Centers for Disease Control and Prevention (CDC) and state and local partners, reported an update of its investigation tracking three separate outbreaks linked to romaine lettuce caused by three different strains of E. coli O157:H7.  FDA reported that, through its traceback investigation (pursuant to which investigators from FDA, CDC, the California Department of Food and Agriculture (CDFA), and California Department of Public Health (CDPH) reviewed hundreds of supply chain records, visited several fields, and took a variety of samples from water, soil, soil amendments/compost, scat, and swabs), the agency was able to identify a common grower linked to the outbreaks in Salinas, California, based on available supply chain information.  FDA noted, however, that romaine from this particular grower does not appear to account for all of the illnesses in these outbreaks.
  • On January 15, 2020, FDA provided an update on the status of the investigation, as well as recent findings by the agency based on its further investigation of fields linked to the common grower it had previously identified.
  • In the January 15 statement, FDA officially lifted its November 22, 2019 consumer advisory (to avoid romaine lettuce grown in Salinas), as the growing season for this region has concluded, and FDA found there was no longer a need for consumers to avoid it.  Additionally, FDA and CDC had been tracking two multi-state romaine lettuce outbreaks (one that sickened 167 people in 27 states, and another, linked to salad kits, that sickened 10 people in five states), as well as a third outbreak in Washington State (that sickened 11 people).  In its January 15 statement, FDA also declared each of these outbreaks to be officially over.
  • On January 7, 2020, a European Food Safety Authority (EFSA) report looked at tetrahydrocannabinol (THC) levels in 12 different categories of hemp foods, including hemp oil, breads and teas.  EFSA also reviewed THC levels in foods, like cereals, pasta, chocolate, and beer.  More than 1,500 samples were collected from countries, such as Romania, Czech Republic, Germany, and Italy.
  • In its report, EFSA noted that THC levels in people ingesting large amounts of hemp products could exceed a safety threshold for THC in food, which could potentially lead to effects on the central nervous system and an increased heart rate.  The report noted that little is known about the number of people eating hemp products or how much those people may be consuming.
  • In the European Union (EU), varieties of hemp that are cultivated and used for feed must be listed in the EU’s ‘Common Catalogue of Varieties of Agricultural Plant Species’. Although the EU allows some varieties of hemp to be used in food, it limits the amount of THC.  According to Regulation (EU) No 1307/20131, the maximum content of THC in these varieties is limited to 0.2 %.  THC is currently not regulated under any EU regulation for food; however, member states, like Italy and Germany have set their own regulations governing THC.
  • The European report called for additional studies, and the authors stated that THC testing in food is far from exact as “there is documented uncertainty with the exact quantification of THC in food due to analytical methods, extraction efficiency as well as in relation to conversions related to food processing.”  We will continue to monitor any developments.
  • On January 9, the Center for Science in the Public Interest (CSPI) sent a letter to Dr. Susan T. Mayne, Director of the Center for Food Safety and Applied Nutrition (CFSAN) at FDA, urging the Agency to “take immediate enforcement action to prevent unauthorized implied ‘low sugar’ and ‘reduced sugar’ claims, such as ‘lightly sweetened’ and ‘less sweet’ on beverage products that are high in sugar.”  CSPI argues that these claims mislead consumers and are in violation of the federal Food, Drug, and Cosmetic Act (FDCA).
  • In the letter, CSPI identified 19 products from 5 brands that they allege make unauthorized implied “low sugar” or “reduced sugar” claims. “Low sugar” and “reduced sugar” claims are nutrient content claims (NCCs), which are claims that expressly or implicitly characterize the level of a nutrient of the type required to be in nutrition labeling.  NCCs may not be made on labels or in labeling unless the claim is made in accordance with the regulations authorizing the use of that claim. CSPI argues that claims such as “lightly sweetened,” “sorta sweet,” “slightly sweet,” and “just a tab sweet” are synonyms for “low sugar” and are therefore prohibited under federal law because “low sugar” is not a defined or permitted NCC. Similarly, CSPI alleges that some products make “less sweet” claims but do not meet the requirements to make a “reduced sugar” NCC.
  • In addition to urging the FDA to take enforcement action against the manufacturers identified in the letter for making implied “low sugar” and “reduced sugar” claims, CSPI encourages the Agency to issue regulations authorizing a “low added sugar” NCC to allow the claim to be made on products that are low in added sugars. CSPI recommends the NCC be based on a per-reference amount customarily consumed (RACC) threshold, similar to the requirements for other “low” NCCs.
  • Notably, Kellogg recently settled a class action lawsuit over use of the label claims “lightly sweetened,” “healthy,” “nutritious,” and “wholesome,” on select cereals, including Krave S’Mores and Cinnamon Roll Frosted Mini Wheats. Plaintiffs argued the claims implied that the cereals were low in sugar when they actually contained 18 – 40% added sugar. In response, Kellogg stated that it had never advertised the cereals as “low sugar” or “reduced sugar,” and that the sugar content was clearly listed on each product’s Nutrition Facts Panel. The class action lawsuit settled for $20 million.
  • On December 14, 2019, the new Official Controls Regulation (OCR) 2017/625 entered into force in the European Union (EU). While the new OCR does not revolutionize the system in place, it provides certain key changes to ensure that food and feed are safe in Europe. Until December 13, 2019, the EU system of official controls was governed by separate pieces of legislations which covered food and feed safety, plant health or animal-by-products. The new OCR intends to simplify this complex framework by either repealing or amending the legislations to provide a coherent approach, and this, toward official controls along the all agri-food chain. Indeed, the new OCR does not only ensure food and feed safety from the traditional “farm to fork” but it also encompasses a multidimensional aspect that includes the environment.
  • The new OCR also includes provisions toward more transparency for the operators which, for example, must assist and cooperate with the staff of the competent authorities in the accomplishment of their task (Article 15(2) as well as for the competent authorities which, for example, must provide a copy of the report to the operators subject to an official control (Article 13). Another key change brought by the new OCR is the extension of the risk-based approach which before was not fully used in certain areas of the law such as border controls of food imported from third country. For a risk-based approach, the frequency of controls should be linked to the risk a product or process presents with respect to the agri-food chain. The evaluation of the risk should, for instance, include the operator’s past records of compliance and the reliability of its own checks as well as any information indicating the likelihood that consumers might be misled about, for example, the properties, quality or composition of the food. This integration of the risk-based approach also reflects the ambitions of the new OCR to make the official controls more efficient.
  • The new OCR includes key provisions in relation to food fraud and e-commerce of foods. Those two aspects were quite extensively discussed during the recent conference organized by the European Commission on December 13, 2019 “Smarter rules for safer food and plant health”. The provisions related to the ‘food fraud’ illustrate the intense debates held during the trialogue negotiations, as at the same time, the horse meat scandal had just broken out. This scandal shown that the system of official controls in place was not sufficient when the issue was not only related to food safety but also invovled misleading and deceptive practices. The new OCR therefore clearly provides that: “Competent authorities shall perform official controls regularly, with appropriate frequencies determined on a risk basis, to identify possible intentional violations of the [Agri-food chain legislation], perpetrated through fraudulent or deceptive practices, and taking into account information regarding such violations shared through the mechanisms of administrative assistance”. Unfortunately, the new OCR does not include a definition of ‘food fraud’.
  • While the new OCR is not a revolution in the field of food safety, it nevertheless provides for key changes. It is now up to the Member States, the European Commission, the operators and countries wishing to import their products in Europe to put them into practice. Keller and Heckman has an extensive food law team in Brussels that can help answer any questions on the new OCR and any other food law matter.

To read more on regulations in the European Union, check out Keller and Heckman’s blog: Tomorrow’s Food and Feed.

  • On December 30, 2019, USDA’s Food Safety and Inspection Service (FSIS) published updated labeling guidelines on “Statements That Bioengineered or Genetically Modified Ingredients or Animal Feed Were Not Used in the Production of Meat, Poultry, or Egg Products.” The guidelines, which were originally announced in August 2016, outline the agency’s approach of approving labels containing “not-bioengineered,” “not genetically modified,” or similar language (i.e., “negative claims”), provided that the claims have been verified by a third-party certifying organization.
  • In response to comments, FSIS clarified in the updated guidelines that it will continue to approve negative claims based either on FDA’s definition of “modern biotechnology” or the Agricultural Marketing Service’s (AMS) definition of “bioengineering” contained in the National Bioengineered Food Disclosure Standard (NBFDS). The agency will also continue to allow the use of synonymous terms such as “genetically engineered” or “GE.”
  • As previously reported on this blog, AMS published the final rule for the NBFDS on December 21, 2018. The rule established detection requirements for the definition of “bioengineered food,” created a list of bioengineered foods, and provided disclosure options for labeling of bioengineered foods, among other provisions.

The Daily Intake will not publish on Monday, January 20, in recognition of Martin Luther King, Jr. Day. The next issue of The Daily Intake will publish on January 21, 2020.

  • On January 13, 2020, the House Agriculture Committee Chairman Collin Peterson (D- Minn.) introduced H.R. 5587, which would include hemp derived CBD in the definition of dietary supplements under the Federal, Drug and Cosmetic Act.  The bill would also require a study and report from the U.S. Department of Agriculture, which oversees the production of hemp, on the regulatory and market barriers for farmers engaged in hemp production.  This would inform growers and policy makers of the challenges facing this new industry.
  • This bill would essentially amend the Dietary Supplement Health and Education Act (DSHEA) by carving out a specific exemption for hemp derived CBD, as DSHEA currently states that a dietary supplement cannot include an article that is approved or under investigation for use in a new drug or biologic, unless that article was previously included in the food supply.  This will remove the barrier for FDA to consider the use of CBD in food, including dietary supplements; however, food companies that wish to use CBD ingredients in their foods remain subject to the relevant laws and regulations that govern all food products, including those that require that food additives obtain premarket approval or be determined to be Generally Recognized as Safe (GRAS) for their intended use.
  • H.R. 5587 was referred to the House Subcommittee on Health of the Committee on Energy and Commerce, which is scheduled to hold a legislative hearing on cannabis policies next week.  We will continue to monitor any developments.
  • On January 10, the FDA announced that it intends to propose that “glucomannan” be added to the definition of dietary fiber at 21 CFR 101.9(c)(6)(i). Based on available evidence, FDA determined that the scientific evidence suggests that glucomannan can help reduce blood cholesterol.  Glucomannan is commonly found in the tuber or root of the elephant yam, also known as the konjac plant. The FDA’s action is in response to a Citizen Petition (CP) filed by The Food Lawyers on February 24, 2018.
  • FDA also denied two CPs on January 13 for isomaltooligosaccharide (IMO), which were submitted by Top Health Ingredients in April 2019, and BioNeutra North America in May 2019. In both denials, FDA stated that “the strength of the evidence does not show that the consumption of IMO has a physiological effect that is beneficial to human health.”
  • With the granting of the glucomannan CP, there are currently 17 categories of non-digestible carbohydrates (NDCs) (including a broad category of mixed plant cell wall fibers) that are either included in the definition of dietary fiber, or are non-digestible carbohydrates that FDA intends to propose to be added to the definition of dietary fiber. Those NDCs are as follows: beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum, hydroxypropylmethylcellulose, mixed plant cell wall fibers, arabinoxylan, alginate, inulin and inulin-type fructans, high amylose starch (resistant starch 2), galactooligosaccharide, polydextrose, resistant maltodextrin/dextrin, cross linked phosphorylated RS4, glucomannan.
  • There are currently 5 pending dietary fiber CPs that have been submitted for Agency review. Notably, some CPs have been under FDA review for upwards of 9 months or more. FDA states the CPs will be reviewed on a rolling basis, with the most recent CP submitted in December 2019 for alpha-cyclodextrin.