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POM Wonderful pursues false advertising claim against Coca-Cola. (subscription to Law360 required)

  • As previously covered on this blog, POM Wonderful sued Coca-Cola in 2008 under the Lanham Act for allegedly misleading consumers with its labels for Minute Maid pomegranate blueberry juice.  According to POM, Coke’s labels misrepresented the amount of actual pomegranate juice present in a blend comprised primarily of apple and grape juice.  Although Coke attempted to defend the lawsuit by asserting the preclusive effect of a company’s compliance with FDA’s labeling requirements, the Supreme Court ruled that FDA compliance does not necessarily provide a safe harbor to protect a company against challenges by competitors or consumers.
  • POM and Coke now are back in California federal court, with POM accusing its competitor of false advertising in connection with its now-discontinued Minute Maid product.  As a result of Coke’s allegedly misleading labeling, an expert for POM believes the company suffered lost profit damages of up to $77.5 million.  Among other strategies, Coke is attempting to assert an “unclean hands” defense, focusing the jury’s attention on a 2012 administrative judge’s ruling that POM made unsubstantiated health benefit claims about pomegranate juice.
  • The current round of POM v. Coke represents the anticipated aftermath of the Supreme Court’s decision, which paved the way for this lawsuit to proceed.  The food industry is paying close attention to the challenge, as the proceedings and outcome may help illustrate the viability of the “unclean hands” defense and, more generally, of false advertising claims and damages in a market with multiple competitors.

FDA issues final guidance on reduction of acrylamide in certain foods.

  • Acrylamide is a chemical that forms during high-temperature cooking of certain foods, e.g., in the preparation of French fries, toasting of bread, or roasting of coffee.  Data indicate that acrylamide has carcinogenic properties, and this substance was first added to California’s Proposition 65 list of chemicals in 1990.  Industry efforts have been underway to reduce acrylamide levels in the food supply.
  • FDA has issued final guidance to the food industry regarding steps that may be taken to reduce acrylamide levels in certain foods.  The guidance provides recommendations specific to potato-based foods, cereal-based foods, and coffee that may assist growers, food processors, and food service operators with reducing the level of acrylamide that forms in these products.
  • Although the Agency does not suggest maximum recommended levels for acrylamide in the food supply, FDA suggests that manufacturers maintain awareness of acrylamide levels in their products in order to determine the effectiveness of reduction techniques.  FDA plans to continue to monitor acrylamide levels in food to determine whether reductions occur over time.

FDA confirms further delay of enforcement of menu labeling requirements.

  • Over the past few years, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act.  Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar menu items) must provide calorie and other nutrition information for standard menu items.  The menu labeling requirements originally were scheduled to take effect on December 1, 2015.  FDA subsequently delayed enforcement to December 1, 2016.
  • As we have previously reported, among the food-related provisions in last December’s omnibus spending bill was a requirement that FDA delay implementation or enforcement of the menu labeling requirements until one year after final guidance is published.  On March 9, FDA issued an official statement confirming this delay.  FDA issued draft menu labeling guidance in September 2015, but has provided no definite time frame for the issuance of final guidance.
  • In reality, the omnibus bill restricts only the use of federal funds to implement or enforce the menu labeling requirements.  Thus, it is at least arguable that a state or local authority could use its own funds to begin enforcing the rule starting on December 1, 2016.  In light of this ambiguity, many companies continue to move ahead with implementing their compliance strategies with December 2016 as the targeted time frame.

Amarin settlement paves way for “off-label” promotion of omega-3 product.

  • As previously covered on this blog, the pharmaceutical industry has been awaiting the resolution of the groundbreaking Amarin case.  At the heart of the case is Amarin’s marketing of Vascepa, an omega-3 drug product, as effective in treating patients with “persistently high” triglyceride levels, as compared to the “very high” level specified in FDA’s approval.  FDA took the position that such marketing practices constituted impermissible “off-label” promotion, but a New York federal judge ruled last year that the company had a First Amendment right to provide doctors with truthful and non-misleading information about the drug’s efficacy.
  • On March 8, Amarin and FDA reached a settlement to close the case, under which Amarin will be permitted to engage in truthful and non-misleading speech promoting the off-label use of Vascepa.  The settlement also provides for dispute resolution procedures and a special consultation process in which FDA will pre-review up to two promotional pieces per year for off-label uses of Vascepa.
  • The Amarin case is being hailed as a First Amendment victory for the pharmaceutical industry, but its wider implications remain to be seen.  FDA maintains that the settlement applies only to the Amarin case and its unique facts, which included particularly high-quality substantiation for the off-label use at issue.  Without a doubt, the Amarin case is precedential for the pharmaceutical industry, the Agency, and the judiciary.  At the very least, this case represents a chink in FDA’s armor and confirms that at least certain types of off-label promotion warrant constitutional protection.

FDA updates dietary supplement labeling guidance to confirm “dietary supplement” as appropriate SOI.

  • In April 2005, FDA issued a guidance document entitled, “A Dietary Supplement Labeling Guide.”  The guidance covers the most frequently raised questions related to dietary supplement labeling in a Q&A format, and for years, it has served as a resource for the supplement industry.  Unfortunately, the guidance contained a confusing and erroneous response to a key question, namely:  “Can the term ‘dietary supplement’ by itself be considered the statement of identity?”  The response to this question said that it could not, which was inconsistent with the Federal Food, Drug, and Cosmetic Act and FDA regulations.  Although FDA and the industry have known about this error for over a decade, it went uncorrected.
  • On March 7, 2016, FDA issued a Federal Register notice finally correcting this fundamental error in the guidance document.  In response to the same question, the revised guidance now reads:
    • Yes. This term describes the basic nature of a dietary supplement and therefore is an “appropriately descriptive term” that can be used as the product’s statement of identity. The statement of identity for a dietary supplement may therefore consist simply of the term “dietary supplement,” or “dietary supplement” may be part of a longer statement of identity (e.g., “cod liver oil liquid dietary supplement”). In either case, the word ‘‘dietary’’ may be deleted and replaced by another appropriately descriptive term identifying the contents of the product, such as “calcium supplement,” “herbal supplement”, or “herbal supplement with vitamins.”
  • Although the error in the initial guidance document may have seemed relatively basic — and was widely disregarded as erroneous by the dietary supplement industry — mistakes of this nature can have consequences.  Particularly in today’s litigation environment, plaintiffs’ lawyers and courts look to FDA guidance as an authoritative resource in determining the appropriateness of industry conduct.  Examples such as this highlight the danger inherent in over-reliance on FDA guidance and also how difficult it can be for FDA to revise guidance even to correct even a clear and widely-acknowledged error.

FDA seeks input on risk assessment regarding use of raw manure as produce fertilizer.

  • Among the issues addressed in FDA’s final rule related to produce safety under the FDA Food Safety Modernization Act (FSMA) is the use of untreated biological soil amendments of animal origin (BSAAO).  Untreated BSAAO are essentially raw manure from cattle and other farm animals (e.g., poultry litter, horse manure).  Some produce farms use untreated BSAAO for a variety of reasons, including the fact that they are relatively cheap, readily available, and serve as rich nutrient sources for growing crops.
  • FDA is planning to conduct a risk assessment to determine the extent to which the use of raw manure as fertilizer in growing crops poses a risk to human health and to develop an approach to help prevent contamination that leads to foodborne illness.  To kickstart this process, the Agency is seeking input from stakeholders in the produce industry, the animal agriculture industry, academia, and members of the public.  FDA is specifically interested in receiving scientific data on pathogen detection and quantification, the prevalence and use of untreated BSAAO, and on-farm practices with respect to BSAAO.
  • In FDA’s view, the use of untreated BSAAO is a food safety issue.  Pathogens that live in animal intestines (e.g., E. coli O157:H7 and Salmonella) can be transmitted to manure and then to produce when untreated BSAAO are applied during cultivation.  The final produce safety rule does not prohibit the use of untreated BSAAO on farms, and in fact, FDA has reserved a decision on the minimum interval between the application of untreated BSAAO and the crop harvest when certain application methods are used.  FDA anticipates developing a quantitative application interval standard in the future, and the information derived from this risk assessment likely will play an integral role in standard development.  A Q&A about FDA’s current request for comments is available here, and comments may be submitted until May 3, 2016.

New mandatory GM labeling bill introduced in Senate.

  • We have seen significant activity on the Hill this week related to the labeling of genetically modified (GM) foods.  On March 1, the Senate Agriculture Committee approved a bill that would establish a voluntary, USDA-administered GM labeling regime and preempt state requirements in this area (including those slated to take effect in Vermont later this year).
  • On March 2, Senators Jeff Merkley (D-Oregon), Patrick Leahy (D-Vermont), Jon Tester (D-Montana), and Dianne Feinstein (D-California) introduced a new bill, S.2621 — the Biotechnology Food Labeling Uniformity Act — to establish a mandatory federal labeling regime for GM foods.  The bill would preempt state GM labeling requirements (including Vermont’s), and would require manufacturers to disclose the presence of GM ingredients in food on the information panel of the label in one of four ways:
    • Stating “(Genetically Engineered)” after each relevant ingredient in the ingredient list;
    • Identifying GM ingredients with an asterisk linked to an explanation after the ingredient list;
    • Indicating generally at the end of the ingredient list that the product was produced or partially produced with genetic engineering (with the exact wording of the statement to be established by FDA); or
    • Use of a symbol on pack (to be developed by FDA in consultation with food manufacturers) that would clearly and conspicuously indicate the presence of GM ingredients.
  • The framework, which would be administered by FDA, provides some exemptions from labeling, e.g., where processed food contains <0.9% GM ingredients by weight; and where GM processing aids were used in food production.
  • Congress, the food industry, and consumer advocates remain divided over the right approach to GM labeling.  Although many food industry stakeholders support voluntary GM labeling at the federal level, the latest mandatory labeling initiative has been endorsed by Campbell Soup Company, Amy’s Kitchen, Ben and Jerry’s, and Nature’s Path.

FSIS audit asks Canada to strengthen its food safety procedures.

  • The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) regulates the quality, safety, and labeling of meat, poultry, and egg products marketed in the United States.  In 2014, FSIS conducted an audit of Canada’s meat, poultry, and egg systems and found deficiencies that caused the Agency to question the adequacy of Canadian standards with respect to these product categories.  Specifically, FSIS identified procedural “weaknesses related to government oversight, sanitation, and microbiological testing that raise significant questions about the Canadian system…and that will need to be addressed…in order to maintain on-going equivalence to the United States’ system.”
  • According to a series of recent media reports, FSIS requested that Canada comply with the recommendations stemming from that audit, or else face the possibility that meat, poultry, and eggs exported to the U.S. will be blocked.  These reports have emphasized the existence of a mid-March deadline for the Canadian Food Inspection Agency (CFIA) to make the necessary improvements.
  • CFIA has responded to the flurry of media criticism by stating that no outstanding issues need to be addressed in connection with the audit findings.  Characterizing the FSIS audit as “routine,” CFIA indicates that the country’s food safety systems have undergone inspections by many other countries and insists that Canada’s meat, poultry, and egg inspection systems are equivalent to the American regime.  CFIA also maintains that the audit has had no adverse impact on Canadian-U.S. trade.

GM labeling bill clears Senate Agriculture Committee.

  • As the July 1 deadline for compliance with Vermont’s labeling requirements for genetically modified (GM) foods draws nearer, many continue to hope for a federal legislative fix.  In February, Senator Pat Roberts (R-Kansas) introduced legislation to establish a national voluntary labeling standard for GM foods.  Significantly, this bill would preempt separate state requirements in this area, including Vermont’s.
  • On March 1, the Senate Agriculture Committee approved the Roberts bill, with 14 out of 20 committee members (including 3 Democrats) voting in favor of the markup.  The bill now moves to the Senate floor for a vote.
  • The Roberts bill is similar to the Safe and Accurate Food Labeling Act of 2015 (which the House of Representatives passed in July 2015).  A key difference is that the Roberts bill lacks some of the detail of the Safe and Accurate Food Labeling Act, such as express provisions allowing companies to make “natural” claims on GM foods and allowing foods to be labeled “non-GM” even if they are produced with GM processing aids or enzymes.  Even without these details present, the bill has garnered significant support within the food industry and the committee’s vote is being lauded by the Grocery Manufacturers Association (GMA), the Biotechnology Innovation Organization, and the Food Marketing Institute (FMI).  As before, we will track the progress of this bill and continue to report on GM labeling developments as the clock ticks down to July 1.

 

NY appeals court grants interim stay for sodium warning.

  • Just last week, a New York Supreme Court judge upheld New York City’s precedent-setting sodium warning requirement for chain restaurants.  Starting on March 1, restaurants that failed to display the required warning language to indicate high-sodium foods would have been subject to fines.
  • On February 29, a New York appeals court granted an interim stay of enforcement of the rule.  The current action puts the rule on a temporary hold pending a decision of a full panel of the court later this month.
  • Counsel for the National Restaurant Association has lauded the appellate court’s action, although NYC officials state that they remain “confident” that they will ultimately prevail despite the temporary stay of enforcement.  The Department of Health plans to continue to warn non-compliant restaurants in the meantime, even though they will not issue notices of violation while the stay is in place.

Cheese company executive pleads guilty to misdemeanor charge.

  • Following up on our recent post about allegations of widespread economic adulteration of parmesan cheese, the president of Castle Cheese, Inc. — the company that received a 2013 FDA Warning Letter for marketing “parmesan cheese” products that did not contain any actual parmesan cheese — has pleaded guilty to misdemeanor adulteration and misbranding charges.  As part of a deal with prosecutors in the case, the executive will receive probation instead of a prison sentence, and two other businesses controlled by her family will have to forfeit $500,000 each.
  • In a development that will come as little surprise to the food industry, multiple class action lawsuits have been filed based on allegations that parmesan cheese products on the market are labeled as “100% Parmesan Cheese” although they also contain wood pulp.  Kraft Heinz and Wal-Mart are among the companies defending these suits.