Judge dismisses proposed class action lawsuit filed by “serial plaintiff.” (subscription to Law360 required)

  • As previously covered on this blog, a lawsuit was filed in the “Food Court” in which the plaintiff alleged that that the presence of partially hydrogenated oils (PHOs) in defendant’s noodle products may violate California law.  The judge found “plausible allegations” under:  (1) the Unfair Prong of California’s Unfair Competition Law (based on allegations that the use of trans fats in foods poses risks to public health and that the only utility of such use is that it is less expensive than safe substitutes) because the law applies a balancing test of harm and utility; and (2) the breach of implied warranty of merchantability (based on allegations that foods containing trans fats are not fit for human consumption due to the associated health risks).
  • On August 14, 2015, the judge dismissed the proposed class action lawsuit, finding that the plaintiff’s prior significant involvement in PHO-based lawsuits negated his claims in the instant case.  In his ruling, the judge explained that the plaintiff was aware of the following key facts prior to buying the noodle products:  (1) products could be labeled “0g Trans Fat” if they contained < 0.5 grams of trans fat; (2) PHOs contained artificial trans fat; (3) he could check ingredient lists on food labels to see if they contained PHOs; and (4) artificial trans fat was linked to health risks.  Further, the plaintiff admitted that he actually had inspected other product labels to verify the presence of trans fat prior to buying them.  The judge dismissed the lawsuit without leave to amend, concluding that “no amendment to the pleadings can overcome the fact that plaintiff could have avoided any injury caused by defendants’ [sic] use of artificial trans-fat in its noodles.”
  • The ruling indicates that “serial plaintiff” status may be self-defeating.  Ultimately, this ruling may help food industry defendants who find themselves opposing repeat players in campaigns against particular claims or ingredients.

RNA spray is touted as an alternative to GMOs.

  • The cultivation of genetically modified (GM) crops and the use of GM ingredients in foods continue to be sources of worldwide controversy.  In a recent development, Scotland has announced its intent to ban GM crop growth in its territory.  And debates continue to be waged over the future of mandatory GM labeling in the United States.
  • As an alternative to genetic modification, biotechnology companies are developing “RNA spray” to improve the yield of cultivated crops.  The RNA spray is applied directly to conventional crops; when destructive pests feed on the plants, the spray shuts down a gene in the insects that is vital to their survival.  Reportedly, RNA spray also may be used to convey advantageous traits to the plants themselves, such as providing temporary drought resistance to crops during harsh harvest conditions.  RNA sprays only inhibit genes for a few days or weeks at a time, so they will not produce permanent effects on the crops to which they are applied.
  • Although no evidence indicates that RNA sprays will produce harmful effects, this new technology may require the resolution of novel issues from a pesticide regulatory perspective and is likely to be met with opposition from consumer safety groups.  It remains to be seen whether this “GMO-free” approach will gain traction as a cost-effective and marketing-friendly alternative to GM crops in the food industry more broadly.

Consumer research surveys indicate that misconceptions about GM foods abound.

  • As the food industry is well aware, questions and concerns continue to be raised surrounding the use of genetically modified (GM) crops and ingredients in the food supply.  Although no reliable scientific evidence suggests that GM foods are any less safe than their conventional counterparts, many consumer advocacy groups and consumers have continued to demand increased transparency about GM foods on the shelves.  Vermont’s GM labeling mandate — which is set to take effect in July 2016, but which is currently being challenged by food industry groups — is an example of the type of “right-to-know” legislation that many consumers support.
  • Recent consumer research surveys involving thousands of participants in the United States and other major markets suggest that a majority of consumers may harbor fundamental misconceptions about the safety and quality of GM foods.  According to one survey by Health Focus International, 87% of consumers worldwide believe that non-GM foods are either “somewhat” or “a lot” healthier than GM products.  63% of consumers responded that GM foods are “less safe to eat,” and 55% believe GM crops are “worse for the environment.”
  • The survey results highlight the uphill battle that the food industry faces in trying to fight mandatory GM labeling initiatives while unfounded consumer concerns about the health, safety, and environmental effects of GM foods continue to proliferate.

In case you missed it, click here to view Keller and Heckman’s complimentary 30-minute webinar on the current and future status of GM labeling in the U.S.

FDA issues warning about bacterial contamination in tattoo inks.

  • FDA has the authority to regulate the safety of cosmetics in the United States.  Tattoo inks meet the statutory definition of a “cosmetic,” which means:  “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”  FD&C Act § 201(i) (underlined emphasis added).
  • FDA has issued a warning to tattoo artists and consumers not to use certain tattoo inks due to potential microbial contamination.  FDA tested the inks in the course of assisting the Florida Department of Health in its investigation of an outbreak of mycobacterial infections in individuals who recently got tattoos.  In the course of testing, FDA detected bacteria — including Mycobacterium chelonae — in unopened bottles of inks.  The manufacturer currently is conducting a recall of affected product.
  • Although FDA enforcement action in the cosmetic arena is relatively rare, FDA’s public warning and the adverse publicity surrounding tattoo ink contamination serves a reminder of the Agency’s authority in this space.

European Court of Justice rules that EFSA may not keep names of expert reviewers confidential.

  • In recent years, the European Food Safety Authority (EFSA) has been criticized for an alleged lack of transparency in the way that its experts review and consider data to support product safety assessments.  Historically, EFSA has not disclosed the names of the expert reviewers involved in any given review.  In 2010, two parties with an interest in a particular EFSA guidance document requested that EFSA release specific documents related to its preparation, including the comments of expert reviewers.  EFSA denied the request in part, specifically refusing to disclose information about the expert reviewers.  The parties sought further relief in court.
  • In July 2015, the European Court of Justice (ECJ) issued a ruling that may bar EFSA from keeping the names of its expert reviewers confidential in the future.  Also, the ECJ ruling could be applied retroactively, thus requiring EFSA to release the names of experts involved in past reviews.  It appears that requests for such information will be assessed on a case-by-case basis.
  • The ruling is being heralded as a victory for those who seek enhanced transparency in the EFSA regulatory process.

Scotland bans GM crops.

  • In early 2015, the European Parliament adopted a law permitting member states to prohibit or restrict the cultivation of genetically modified (GM) crops in their territories, even where such cultivation is permitted at the EU level.
  • The Scottish government has announced its intent to ban the cultivation of GM crops in its territory, citing the GM “opt-out” provision expressly provided for in European law.
  • Scotland’s action highlights the potential fragmentation of the EU into “pro-GM” and “anti-GM” territories, which will diminish predictability and flexibility for biotechnology companies in the European marketplace.

Federal court ruling paves the way for off-label promotion of fish oil product.

  • FDA’s historical position is that “off-label promotion” — the promotion of pharmaceutical products for unapproved uses — violates the Federal Food, Drug, and Cosmetic Act.  The underlying logic is that:  (1) drugs are misbranded when they fail to bear adequate directions for a lay person’s use; (2) prescription drugs cannot bear adequate directions for use by a lay person (as their use must be supervised by a health care provider); and (3) although a statutory exemption exists in the context of prescription drug labeling, the drug must have labeling that directs licensed practitioners to use the drug safely for all intended purposes.  Essentially, the promotion of a drug for an off-label use establishes a new intended use for which no adequate directions have been provided in labeling.  FDA and the industry have sparred over the issue of off-label promotion for years, with FDA holding firm to its restrictions and the industry asserting that the First Amendment permits more information to be shared.  Recently, Amarin (a pharmaceutical company) challenged FDA’s off-label promotional ban in federal court.  The company sought an injunction that would effectively permit Amarin to share efficacy data with doctors where the data support a therapeutic indication not yet approved by FDA.
  • In a groundbreaking ruling, a New York federal judge granted Amarin’s preliminary injunction and ruled that the company has a First Amendment right to provide doctors with truthful and non-misleading information about the drug’s efficacy in treating patients with “persistently high” triglyceride levels, as compared to the “very high” level specified in FDA’s approval.
  • The ruling marks the first time that a federal court has so expressly stated that off-label promotion warrants First Amendment protection.  FDA has 60 days to appeal the decision, but has not yet indicated its plan of action.  Although the lawsuit is fairly narrow and restricted to specific statements about one particular drug, it may have broad implications for the drug industry and could open the door to a major change in FDA’s historical authority to restrict off-label promotion.

FDA issues guidance on the use of nanomaterials in animal food.

  • Nanotechnology refers to emerging technology that uses materials in the nanoscale range (with at least one dimension in the size range of approximately 1 nanometer (nm) to 100 nm).  Nanomaterials may exhibit different chemical or physical properties, or even different biological effects, as compared to their larger-scale counterparts.  Nanotechnology may be used to produce FDA-regulated products such as foods, drugs, and cosmetics.  FDA has developed an approach to the regulation of nanotechnology products and has issued various guidance documents on the regulation of nanomaterials in specific product categories.
  • In August 2015, FDA issued a final guidance document regarding the regulation of nanomaterials in food for animals. Nanomaterials intended for use in animal food are subject to the same regulatory pathways as conventional materials, but FDA notes in its guidance that, “[a]t this time, [the Agency is] not aware of any animal food ingredient engineered on the nanometer scale for which there is generally available safety data sufficient to serve as the foundation for a determination that the use of such an animal food ingredient is [generally recognized as safe] GRAS.”  Parties interested in using nanomaterials in animal food in the United States thus are encouraged to submit a food additive petition (FAP) to FDA to permit such use.  The guidance specifies various considerations that manufacturers should take into account when preparing an FAP for a nanomaterial animal food additive.
  • Significantly, the Agency excludes from the scope of the guidance any materials or end products that contain naturally-occurring substances in the nanoscale range or that contain incidental quantities of nanomaterials with no further deliberate manipulation or engineering.  FDA’s guidance applies to “materials or end products that involve the application of nanotechnology to deliberately manipulate or control particle size in order to produce specific technical effects.”  The guidance therefore is of most direct relevance to parties seeking to harness nanotechnology to develop novel materials for use in animal food.

GMA submits food additive petition to FDA to seek approval of low-level PHO uses.

  • As previously covered on this blog, FDA recently announced that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs) are generally recognized as safe (GRAS) under any conditions of use in food.  Going forward, PHOs will be regulated as food additives, which — unlike GRAS substances — require FDA approval prior to use in food.
  • A leading food industry trade association, the Grocery Manufacturers Association (GMA), has submitted a food additive petition to FDA seeking the Agency’s approval of specific low-level uses of PHOs.  GMA asserts that scientific data — including diet intervention studies, meta-analyses, and mode of action data — demonstrate that people may consume up to 1.5% of their daily energy from trans fat without adversely affecting “bad cholesterol” levels.  GMA indicates that consumers would not exceed the 1.5% consumption threshold if FDA approves its petition.
  • Submission of the food additive petition is just the beginning of a long review and approval process.  Even if FDA’s review goes smoothly, a final approval still may be two or three years away.  GMA officials have indicated that they are currently preparing an environmental assessment (EA) at FDA’s request and that they expect FDA to formally accept (or “file”) the petition after the EA has been submitted.  In the meantime, the food industry continues to grapple with the legal and practical challenges that exist in the wake of FDA’s declaration that PHOs are not GRAS.

USTR indicates that COOL damages are much lower than Canada and Mexico estimated.

  • As previously covered on this blog, the U.S. government continues to develop strategies to cope with the aftermath of a World Trade Organization (WTO) ruling that mandatory country of origin labeling (COOL) requirements unfairly discriminate against meat imports.  Because COOL requirements are statutory in origin, Congress is tasked with repealing or amending the COOL regime to mitigate exposure to trade sanctions.  Canada and Mexico have sought $3 billion in retaliatory tariffs.
  • The United States Trade Representative (USTR) has filed briefs in the WTO dispute, indicating that $3 billion is an overestimate of the damages in this case.  The briefs provide cost models and arguments to support requests by the U.S. that the WTO reject the original values and instead set damages at $43.22 million for Canada and $47.55 million for Mexico.
  • Congress has yet to take final action to repeal or amend the COOL requirements.  The House of Representatives passed a bill to repeal the requirements in June and the Senate is considering a separate bill that would institute a voluntary COOL regime in place of the mandatory requirements.  In light of the significant disparity between Canada’s and Mexico’s estimated damages and the USTR figures, it remains to be seen whether Congress will wait for the WTO’s ruling on the retaliatory tariffs before taking further action.  The WTO has scheduled a hearing on this matter for September 15-16 in Geneva.

Federal judge strikes down Idaho “Ag-Gag” law.

  • As previously covered on this blog, several states have enacted “Ag-Gag” laws that generally seek to prevent individuals or organizations from investigating and publicizing farming conditions and practices that occur on private property.  Thus far, Utah’s and Idaho’s laws have been challenged on 1st and 14th Amendment grounds.
  • On August 3, 2015, an Idaho federal judge ruled that the state’s Ag-Gag law is unconstitutional.  According to the ruling, the law violates the 1st Amendment by suppressing free speech.  The judge also held that the law violates the Equal Protection clause of the 14th Amendment because, in his view, the statute was enacted to target and limit the efforts of animal rights activists.  Idaho’s attorney general has not yet announced whether the state plans to appeal the decision in the Ninth Circuit.
  • Utah’s Ag-Gag challenge is still proceeding, so it remains to be seen how a district court in the Tenth Circuit will rule on substantially similar issues.  If the ruling is consistent, this could spell the end of Ag-Gag laws in several other states.  But if Utah’s law is upheld and a circuit split ensues, Ag-Gag issues could make their way to the Supreme Court.  In either case, Idaho’s landmark ruling casts doubt on the future of Ag-Gag laws and bills across the nation.