• The Federal District Court for the Northern District of California has granted Dr. Pepper/Seven Up, Inc.’s Motion to Dismiss (available for purchase here) in a putative class action originally filed in October 2017, which alleged that the marketing of Diet Dr. Pepper violated California’s False Advertising Law, Consumer Legal Remedies Act, and Unfair Competition Law, as well as breached both express and implied warranties.
  • Plaintiffs had filed a third amended complaint that attempted to bolster its arguments that Diet Dr. Pepper’s marketing and advertising were false and misleading.  The complaint included citations to the dictionary definitions for “diet,” discussions of print and video advertisements, and scientific articles and studies.  Plaintiffs attempted to establish, in part, that aspartame, the FDA-approved artificial sweetener in Diet Dr. Pepper, causes weight gain.
  • The court granted the defendant’s motion to dismiss, concluding that it is not plausible that reasonable consumers would believe that consuming Diet Dr Pepper leads to weight loss or healthy weight management, absent a change in lifestyle. The court stated that “[t]he new studies Becerra included in the third amended complaint still fail to offer a single finding of causation between aspartame or diet soda products and weight gain…correlation is not causation, neither for purposes of science nor the law.”  The decision should be considered a victory for industry and could serve to dissuade other suits against diet beverages.
  • On August 17, 2018, a California federal judge certified three classes of consumers who allege that Kellogg falsely advertises its Raisin Bran, Frosted Mini-Wheats, and Smart Start cereals as healthy. The 51-page order granting the motion for class certification found claims that Kellogg misled consumers about the sugar contents of its cereals can be resolved on a class-wide basis. However, the judge refused to certify a similar class of consumers who bought Nutri-Grain breakfast bars because the court would have to engage in individualized inquiries to determine which members of the class were injured.
  • The lawsuit was brought against Kellogg in August 2016 by plaintiff Stephen Hadley. In his complaint, Hadley points to various phrases on product labels as evidence of false advertising. For example, the Frosted Mini-Wheats and Smart Start labels say “lightly sweetened” and the Nutri-Grain bars say “wholesome goodness,” which Hadley argues implies that the products are low in sugar, even though they contain 18 to 40 percent added sugar. Other phrases at issue include “nutritious,” “essential nutrients,” and “wholesome,” however claims about phrases like “unbelievably nutritious” and “positively nutritious” were deemed as puffery and dismissed by the court in August 2017.
  • Notably, Hadley is also a co-plaintiff in a similar false advertising lawsuit against General Mills. That lawsuit challenges the labeling on 52 kinds of General Mills breakfast cereals with allegedly high sugar content. General Mills has argued that the label claims at issue are implied nutrient content claims that are permitted by the FDA. As of September 2017, the court had partly granted General Mills’ second of three dismissal bids, and had given the plaintiffs an opportunity to file an amended complaint for the second time.
  • Over the past few years consumers have shown increased concern about sugar in the diet and nutrition-related claims. As evidenced by these lawsuits, added sugar has emerged as a hot area for litigation, as has the word “nutritious,” which is often argued as a code-word for healthy and is at the center of many false advertising lawsuits.
  • A bill that would have required warnings on the labels of sugar-sweetened beverages sold in California died in the Senate Appropriations Committee this month (Los Angeles Times). Assemblyman Rob Bonta (D-Alameda) introduced the Sugar-Sweetened Beverage Safety Warning Act, AB 1335, in February 2018.
  • AB 1335 would have banned the sale of sugar-sweetened beverages in sealed beverage containers in California unless the container bears the safety warning shown below.
    • STATE OF CALIFORNIA SAFETY WARNING: Drinking beverages with added sugar(s) contributes to obesity, type 2 diabetes, and tooth decay.
  • The bill also would have required the posting of warning signs on vending machines that dispense sugar-sweetened beverages.
  • California’s governor recently signed a bill that prohibits local government agencies from imposing new taxes on “groceries.”  As previously reported on this blog, that bill was widely seen as a ban on new taxes on sugary drinks in particular.

 

  • FDA issued a final rule more than two years ago, on July 14, 2016, to amend and update the Agency’s food facility registration requirements and implement revisions that were mandated by the Food Safety Modernization Act (FSMA).  FDA’s compliance guidance for the updated food facility registration requirements was issued in draft on November 7, 2016 and was updated – again in draft – on December 27, 2016.  (See previous blog coverage here.)
  • On August 17, 2018, FDA informally announced the availability of the finalized guidance document titled Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.  (See also 83 Fed. Reg. 42024, August 20, 2018.)  FDA concurrently announced the release of a new draft document titled Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration addressing registration requirements when multiple entities are involved in the use of shared physical space, such as where one entity owns a building and lessees manufacture/process, pack or hold food in the building.  (See 83 Fed. Reg. 42062, August 20, 2018.)  All comments on the new supplement that are received by October 19, 2018 will be considered when FDA incorporates it into a future edition of the Q&A Guidance on Food Facility Registration.
  • FDA states that the August 2018 Q&A Guidance on Food Facility Registration has been modified in response to numerous comments received on the draft guidance document.  Changes to the document, however, are not highlighted for easy comparison to the draft guidance.  We are reviewing the August 2018 Q&A Guidance to identify all differences as compared to the draft guidance and determine whether FDA has changed its views on any food facility registration requirements as opposed to merely clarified the Agency’s position.

 

  • FDA Commissioner Scott Gottlieb, MD, issued a statement on August 16 regarding the role of microorganisms on health.  Dr. Gottlieb provided background on the use and regulatory status of microorganisms.
  • Also in his statement, Commissioner Gottlieb provided the underlying rationale for his statement via the example of probiotics administered to premature infants as a preventive measure against a serious disease called  necrotizing enterocolitis.  He pointed out that there have been both benefits and serious side effects reported from the use of probiotics for this disease, noting that data collected on the impact of probiotics are hard to interpret because there is a lack of systemization in the studies.  He also noted that different probiotic preparations have been studied or other interventions have been administered in conjunction with the probiotics.  He concluded by stating that the key is determining when the benefit of probiotics outweighs the potential risks, warning that FDA will consider taking action when it sees unsafe or violative products.
  • FDA has not approved any probiotic as a live biotherapeutic product – a biological product other than a vaccine that uses live organisms – as a drug.  However, there currently are probiotic-containing foods, including dietary supplements, on the market.  Foods with probiotics may not be legally marketed to cure, mitigate, treat, or prevent any disease.
  • FDA is convening a workshop on September 17 to discuss the “clinical, manufacturing, and regulatory considerations associated with microbiome-based products.”  FDA has also issued a guidance document regarding the manufacturing requirements for microorganisms to be used in drug clinical trials.
  • In light of the approaching September 17, 2018 compliance date for small animal food businesses (i.e., those with less than 500 full-time equivalent employees) to comply with Hazard Analysis and Risk-Based Preventive Controls (HARPC) rules, FDA has released a Q&A document concerning what to expect in the near term regarding FDA enforcement and inspections.
  • The Q&A explains that, unlike HARPC for human food, FDA decided to stagger the compliance dates for HARPC and related Current Good Manufacturing Practice (CGMP) rules for animal food because there had not been longstanding CGMPs for the animal food industry.  FDA wanted to give industry time to focus solely on the foundation of CGMPs before imposing more onerous HARPC requirements.  FDA states that it will not conduct regulatory inspections for small businesses to evaluate compliance with HARPC requirements until the fall of 2019 in light of industry feedback that more time and technical assistance is needed to comply.
  • Of course, FDA will conduct inspections of small businesses “for-cause” before the fall of 2019 if, for example, a facility has a history of violative product or environmental samples, there is a recall, there are significant observations made during a previous inspection, or the facility is the subject of FDA or state enforcement action.  FDA’s delay of routine inspections should not be seen as a delay in the HARPC compliance date for small businesses, which remains September 17, 2018.
  • On August 14, 2018, FDA released a constituent update regarding the upcoming compliance dates for the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule under the Food Safety Modernization Act (FSMA). By September 17, 2018, both large and small animal food facilities must comply with preventive controls requirements mandated by FSMA. Large businesses are those with 500 or more full-time equivalent employees, and small businesses are those with fewer than 500 such employees.
  • The compliance dates for the Preventive Controls (PC) and Current Good Manufacturing Practice (CGMP) requirements are staggered for animal food companies. FDA believed a year to solely focus on CGMPs would provide a helpful foundation prior to implementing preventive controls. Large and small facilities previously had to meet the CGMP requirements by September 2016 and September 2017, respectively. Also on September 17, 2018, facilities that are very small animal food businesses will be required to comply with the CGMPs. Very small businesses are those averaging less than $2.5 million per year in sales plus the market value of animal food they make or hold. These facilities are exempt from the full preventive controls requirements, but they have an additional year to meet the requirements applicable to qualified facilities.
  • FDA also published a conversation with consumer safety officer Jenny Murphy from FDA’s Center for Veterinary Medicine. In the conversation, Ms. Murphy explains what animal food producers can anticipate in this phase of implementation of the rule. 2018 will be the first year in which all three business sizes (large, small, and very small) have reached at least one of their compliance dates. 2018 will also be the first year in which FDA will begin routine regulatory inspections to ensure compliance with the preventive controls requirements. Additionally, Ms. Murphy discusses the available resources to assist industry with implementing the regulations, as well as how the final rule applies to producers of human food who supply by-products for use as animal food. Lastly, Ms. Murphy emphasized that FDA is currently focused on educating food producers to ensure the proper development, implementation, and fine tuning of their preventive controls and current good manufacturing practice requirements.
  • The U.S. Department of Agriculture’s (USDA) proposed rule for the National Bioengineered Food Disclosure Standard (NBFDS) originally included three alternative symbols for the symbol disclosure option to label bioengineered (or, “BE”) foods:

2-A                     2-B                     2-C

USDA also included a supplemental document to the proposed rule with the color versions. The preamble to the proposed rule specifically requested comment, in part, on whether the word  “Bioengineered” should be incorporated into the design of the chosen symbol and whether the phrase “May be” should be incorporated into the design of the chosen symbols to account for “may” disclosures.

  • On August 7, 2018, USDA filed six new bioengineered food symbols with the U.S. Patent and Trademark Office, to “certify that a product…is a bioengineered food”:

  • Interestingly, two of the newly filed symbols include the text, “made with bioengineering,” which was not explicitly contemplated in the proposed rule. Further, the new filing do not utilize the “smiley faces” associated with proposed Alternatives 2-B and 2-C, which received much attention in the comments to the proposed rule. Whether USDA adopts any of the newly filed symbols remains to be seen, but nevertheless, the filings do serve as a signal of USDA’s thinking as the Department works to finalize the regulations to implement the NBFDS.

•       As reported by numerous media outlets, a San Francisco jury (in state court) on August 10, 2018 delivered a verdict against Monsanto of $289 million, including $250 million in punitive damages, for a former school groundskeeper dying of non-Hodgkin’s lymphoma.  The plaintiff, Dewayne Johnson, proved to the jury that Roundup herbicide was a “substantial contributing factor” in causing his cancer and that Monsanto failed to warn consumers about the product’s cancer risk.  Monsanto has stated that it will appeal the verdict.
•       Mr. Johnson’s was the first tried of thousands of cases filed by cancer patients or their estates against Monsanto following a March 20, 2015 report by the International Agency for Research on Cancer (IARC) finding glyphosate – the active ingredient in Roundup – is “probably carcinogenic to humans.”  Most other scientific bodies, however, including the U.S. Environmental Protection Agency (EPA) have found that glyphosate is not likely to be carcinogenic to humans.
•       Regarding potential exposure to glyphosate from food, the Food and Drug Administration (FDA) has reported on preliminary results for glyphosate testing that showed no pesticide residue in excess of the EPA tolerances for glyphosate in all four commodities tested (soybeans, corn, milk, and eggs).  New outlets reported in May 2018, however, on internal FDA emails concerning detection of glyphosate at violative levels in unofficial samples of crackers, granola, cornmeal, honey, oatmeal, baby food, and corn (not a designated sample) that were analyzed outside of the planned study.  Official FDA testing for glyphosate in an expanded range of foods began this fiscal year.
•       The California state court verdict against Monsanto for this plaintiff indicates that EPA’s safety conclusion for glyphosate exposure may not be an insurmountable obstacle to other juries potentially finding that Roundup caused or contributed to thousands of other plaintiffs’ cancers.

  • In a Wall Street Journal op-ed, Dr. Henry Miller, the former founding director of the FDA’s Office of Biotechnology, criticizes FDA as giving organic food labeling and advertisement “a complete pass.”  The author calls out FDA’s lack of enforcement on claims that organic foods are grown “without toxic or persistent pesticides,” noting that in fact, organic farmers rely on synthetic and natural pesticides to grow their crops (just as conventional farmers do), and organic products can contain numerous synthetic as well as natural chemicals.  The op-ed also highlights the author’s inability to find a single FDA warning letter or other enforcement action against “non-GMO” claims, where the products have no GMO counterpart or couldn’t possibly contain GMOs.  Ultimately, the author concludes that “consumers need aggressive FDA action to curb these abuses and level the playing field.”

 

  • Two days after the op-ed was published, FDA Commissioner Scott Gottlieb tweeted a pledge to look into the terms used in food packaging, “in coming weeks, I’m going to put out more detailed information on what different terms mean on food packaging, to help consumers best use claims like organic, antibiotic free, etc.” The Commissioner also highlighted the distinct roles FDA and USDA have when it comes to oversight of organic foods. While USDA is charged with regulating use of the term “organic” on food labels through its oversight of the National Organic Program, FDA “oversees general food labeling compliance and safety issues.” Stay tuned for more from FDA on this.

 

  • As for non-GMO claims, this blog has been closely following USDA’s proposed rule for the National Bioengineered Food Disclosure Standard, which proposes to allow food certified under the National Organic Program to make claims regarding the absence of bioengineering in food. How the final rule squares with FDA’s current labeling guidance on foods derived from genetically engineered plants (which states, in part, that a statement claiming absence of genetically engineered ingredients may be false or misleading where there is no GMO counterpart to some of the ingredients) remains to be seen.