USDA AMS Solicits Comments on Draft Instructions for Testing Methods to Confirm the Absence of Detectable Modified Genetic Material


  • As previously covered on this blog, the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) implements the National Bioengineered Food Disclosure Standard (the Standard).  On January 1, 2022, which is the mandatory compliance date for the rule, regulated entities must disclose whether food offered for retail sale is bioengineered (BE) or uses BE food ingredients.  The regulatory definition of “bioengineered food” excludes foods where modified genetic material is not detectable and USDA’s regulations discuss “detectability” at 7 CFR 66.9.  In the issuing the final rule, USDA AMS indicated it would provide further instructions on two of the provisions by which a regulated entity can determine that modified genetic material is not detectable: (1) acceptable testing methodology and (2) validating a refining process.  As we reported, USDA AMS released draft instructions for validation of refining processes on December 17, 2019.  Today, USDA AMS released for comment its draft instructions regarding acceptable testing methodology.
  • The draft instructions for acceptable testing methodology describe factors to consider when selecting a test method that is fit for the purpose of demonstrating that a food does not contain detectable modified genetic material.  The draft instructions state that entities should use validated methods accepted by international bodies (e.g., International Organization for Standardization (ISO) and Codex Alimentarius Commission (Codex)) and/or validate their own methods.  The following international standards are referenced:  ISO 24276 Foodstuffs -Methods of analysis for detection of genetically modified organisms and derived products- General requirements and definitions, ISO 21571 Nucleic Acid Extraction, ISO 21569 Qualitative Nucleic Acid Analysis, ISO 21570 Quantitative Nucleic Acid Analysis, and Codex document CAC/GL 74-2010 Guidelines on Performance Criteria and Validation of Methods for Detection, Identification and Quantification of Specific DNA Sequences and Specific Proteins in Foods.  Additionally, the instructions address DNA-based methods (e.g., polymerase chain reaction (PCR) methods both qualitative and quantitative are noted as being “acceptable”), emerging technologies, and other methods, as well as general considerations in selecting a laboratory and record keeping requirements.
  • Comments on the new draft instructions are due by March 4, 2020.  After USDA reviews the comments received they will publish final instructions on testing methods on their website.  Keller and Heckman has the legal and scientific expertise to assist you as you implement your validated testing methods for your refining processes. We will continue to monitor and report on developments that impact BE labeling.


Nestle Asks California District Court to Dismiss Class Action Lawsuit Claiming that Nestle Knowingly Sold Coffee Creamer Containing Trans Fat to Consumers (Law360 Subscription Required)

  • On January 24, 2020, a Northern District of California judge denied defendants’ motion to dismiss plaintiffs’ complaint.  In Beasley v. Lucky Stores, Inc. et al, consumers of Coffee-mate, a line of coffee-creamer products produced by Nestle USA, Inc. (“Nestle”), brought a putative class action lawsuit against Nestle and a group of retail stores alleging that some flavors of Coffee-mate contained, partially hydrogenated oil, an artificial form of trans fat, even though defendant’s labels included nutrient claims, such as “0g Trans Fat.”
  • In their motion to dismiss, Nestle and the group of retailers argued that the Plaintiff had claimed to only learn trans fat was harmful in January 2017, and thus could not have relied on the “0g Trans Fat” label for his prior purchases. The district judge rejected defendants’ argument and noted that plaintiff’s complaint alleges that he learned at that time that the product “contained an unsafe food additive,” in other words, that the plaintiff learned trans fat was in the creamer, not that it was harmful.  In addition, the judge found that the plaintiff had adequately pled that he relied on the packaging’s claims.  Ultimately, the district judge stated that the amended complaint adequately noted when and where the buyer leading the suit bought the product and that he had relied on the Coffee-mate labeling.
  • A Nestle representative stated that this ruling is “purely procedural in nature and is in no way determinative of the merits of the plaintiff’s allegations, which remain unproven.”  We will continue to monitor any developments.

Comments on Chapter 14: Recall Plan of FDA’s Draft Guidance on Human HARPC Rule Due February 4


Like Numerous Other States, Kansas Bill Would Prohibit Labeling Plant-Based Products as “Meat” Without Disclaimer

  • 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.

China Calls for Comments on New Food Labeling Rules

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.

Proposed Class Action Lawsuit Alleges “Just a Tad Sweet” is an Unauthorized and Misleading Low Sugar Claim for Honest Tea Beverages

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.

FDA Publishes Statement on the Salinas-Linked Romaine Lettuce E. Coli 0157:H7 Outbreak and Status Update on Investigations

  • 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.

European Food Safety Authority Warns that Eating Hemp Foods Can Cause Elevated THC Levels if Ingested in High Quantities

  • 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.

CSPI Urges FDA to Take Enforcement Against Implied “Low Sugar” and “Reduced Sugar” Claims

  • 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.

New Official Controls Regulation in the European Union

  • 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.


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