Bill introduced in Senate to combat overuse of antibiotics in food-producing animals.

  • For years, FDA and various stakeholders have grappled with how best to reduce the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.  In 2013, FDA asked animal pharmaceutical companies to voluntarily revise the FDA-approved conditions of use on antibiotic labels to remove production indications.
  • Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) have reintroduced a bill that would require FDA to withdraw its approval of medically important antibiotics that are at a high risk of abuse in food-producing animals.  The sponsors and supporters of the legislation argue that it addresses gaps in FDA’s 2013 request for voluntary industry participation in the reduction of antibiotic abuse.
  • Antibiotic resistance remains a pressing public health concern.  Future actions by the federal government with respect to reducing antibiotic use have the potential to affect multiple sectors of industry, including animal pharmaceutical manufacturers, farmers, food processors, and even ethanol producers (as antibiotics may be used in ethanol production, the by-products of which are fed to food-producing animals).

APHIS withdraws 2008 proposed rule related to the regulation of GM crops.

  • USDA’s Animal and Plant Health Inspection Service (APHIS) evaluates genetically modified (GM) crops as potential plant pests under the authority of the Plant Pest Act.  On October 9, 2008, APHIS issued a proposed rule that would have expanded its authority to regulate GM crops that may not fit within the “plant pest” definition, but that may cause environmental or other types of physical harm or damage covered by the definition of “noxious weed.”  The proposal also would have substantially modified existing notification, permitting, and deregulation procedures.
  • APHIS has now withdrawn the rule, citing receipt of more than 88,300 comments expressing significant concerns about the key aspects of the proposal.  Stakeholders appear to have been particularly concerned about the lack of details surrounding the determination of which organisms would be subject to APHIS oversight, the multi-tiered permit system, and the perceived expansion of Agency authority.
  • It remains to be seen whether and how APHIS will modify its regulatory oversight of GM crops.  In light of increasing industry and consumer interest in issues related to GM foods, as well as impending federal and state developments in the area of GM labeling and claims, we doubt this issue will go dormant anytime soon.

Pet food class action lawsuit filed against major manufacturer.

  • A class action lawsuit has been filed against Nestlé Purina PetCare Company alleging that ingredients in the company’s Beneful product line pose the risk of adverse health effects or death to pets.
  • Among other issues, the lawsuit calls into question the permissible use of propylene glycol, a known component of antifreeze that also is generally recognized as safe (GRAS) under FDA regulations for use in animal feed and pet food (except for cat food).
  • Nestlé Purina has secured dismissals of previous class action lawsuits based on similar allegations and the fate of the current suit remains to be seen.  Nevertheless, the suit serves as a reminder to industry that even “FDA-approved” or GRAS ingredients are subject to scrutiny and consumer attack where negative perceptions or suspicions of negative health effects may be associated with the substances.

Just Mayo sued again over allegedly deceptive name.

  • In November 2014, Unilever (maker of Hellmann’s mayonnaise) sued Hampton Creek, the maker of a mayonnaise substitute called “Just Mayo.”  Unilever argued that Just Mayo was labeled and marketed as standard “mayonnaise” despite its failure to comply with FDA’s standard of identity for the product.   Under FDA’s definition, mayonnaise must contain egg, which Just Mayo does not.  A month later, however, Unilever dropped the lawsuit.
  • In February 2015, a consumer class action lawsuit based on nearly identical claims was filed against Hampton Creek in federal court in the southern district of Florida.   Shortly after filing, however, the case was voluntarily dismissed; the plaintiffs had not provided sufficient evidence to prove that damages exceeded the requisite $5 million threshold.
  •  Although Hampton Creek appears to have escaped its latest legal challenge, the plaintiffs potentially could re-file their suit in future.  The resurgence of a potential challenge against Just Mayo indicates how easily competitor challenges may trigger consumer lawsuits.   Food marketers should take heed of this risk, particularly as state consumer protection laws may be more flexible or plaintiff-friendly than the Lanham Act.

NY investigation into herbal supplements extends to manufacturers.

  • New York’s Attorney General (AG) recently issued cease-and-desist letters to major retailers, alleging the marketing of misbranded herbal supplements.  Originally, the investigation focused on the contents of specific products, but in recent weeks, the focus has shifted to the substantiation of claims being made for the supplements.
  • The AG now has issued letters to four major supplement manufacturers — Nature’s Way, NBTY, Nutraceutical Corp., and Pharmavite — requesting detailed information about their production and marketing of herbal supplement products.
  • Considering the number of parties involved in the supplement production chain, it is not particularly surprising that the AG now seeks information from manufacturers directly.  The potential exists for the investigation to extend even further to target the suppliers of dietary ingredients too.  The ongoing inquiry also serves as a reminder of the need for companies to ensure adequate substantiation for any claims made about finished products or their ingredients.

Groundbreaking peanut consumption study counsels exposure, not avoidance, for those at risk of allergy.

  • Peanut allergy is one of the most common food allergies, with exposure to the protein triggering severe, potentially fatal allergic reactions in some cases.
  • A study published in the New England Journal of Medicine indicates that exposing individuals at high risk of developing a peanut allergy to peanut products during infancy and early childhood significantly reduces the likelihood that they will ultimately develop the allergy.
  • Since the enactment of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), food manufacturers have been required to label peanuts (among other major allergens) in food.  Complications and challenges arise when companies are dealing with unavoidable cross-contact or test results indicating low levels of incidental allergens.  Although the current research will produce no overnight changes for the allergic population or the food industry, it remains to be seen whether this groundbreaking study will change current misconceptions about allergen avoidance and ultimately decrease the size of the allergic population in the U.S.

Class action lawsuit alleges deceptive labeling of juice products. (subscription to Law360 required)

  • In 2014, the U.S. Supreme Court ruled that POM Wonderful could sue Coca-Cola 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.
  • POM v. Coke clarified that a company’s compliance with FDA labeling requirements does not necessarily provide a safe harbor to protect the company against challenges by competitors or consumers.
  • Another company now faces a class action lawsuit based on allegations that the company misbranded its “Organic Blueberry Pomegranate Juice” by over-representing the proportion of those juices in a blend comprised primarily of apple juice and lemon juice concentrates.  Considering the similarities between the instant suit and the dispute in POM v. Coke, food marketers should be alert to the potential for “copycat” lawsuits involving juice labels — and eventually perhaps other food labels — even where companies feel their labeling is fully FDA-compliant.