FDA finalizes three additional FSMA rules; publication imminent.

  • Although FDA’s implementation of the FDA Food Safety Modernization Act (FSMA) is well underway, the Agency has yet to issue several final rules to implement major provisions of the law.  In 2012, two advocacy groups — the Center for Food Safety and the Center for Environmental Health — sued FDA in federal court over the Agency’s failure to ensure timely issuance of major rules required by FSMA.  Under the terms of a settlement agreement in that case, the court imposed staggered deadlines for FDA to issue final rules, running from August 30, 2015 to May 31, 2016.
  • FDA faced a court-imposed deadline of October 31, 2015 to issue final rules to implement the produce safety standards; the foreign supplier verification program (FSVP); and the Agency’s third-party certification program.  On November 2, the Agency announced its submission of all three rules to the Federal Register office, so publication should occur in the very near term.
  • As with the recently-issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions for human and animal food, Keller and Heckman plans to prepare full analyses of all three final rules once they have been published.

European Parliament votes in new novel food regulations, but confusion lingers.

  • For years, Europe has been debating and considering updates to its 20-year old regulatory framework for novel foods.
  • On October 28, the European Parliament voted to adopt a proposed novel food regulation that will amend the former novel food categories; centralize the authorization process; shift from applicant-based to generic authorizations; and simplify the authorization procedure for traditional foods from other countries.  Due to procedural issues, however, some confusion regarding the wording and legal effect of the Parliament’s vote remains.
  • The text of the regulation subject to the Parliamentary vote was the result of negotiations between the Parliament, the Council, and the Commission.  Because negotiations occurred in advance, the aim of the Parliamentary vote was to adopt the text in its entirety.  However, this did not happen, and the Parliament rejected two proposed revisions concerning the authorization procedure for the marketing of novel foods and the uniform updating of the EU’s novel food list.  In November, the Council is slated to discuss the Parliament’s vote and to determine whether the revised text can be adopted.  The Council’s concurrence is likely; absent such concurrence, the regulation will be subject to further debate and delay.

European Parliament rejects national GM ban proposal.

  • As previously covered on this blog, the European Parliament was set to vote on draft legislation that would permit countries to restrict the use of imported genetically modified (GM) crops that have been approved at the EU level.
  • On October 28, the Parliament rejected the law, with some members noting that the proposal could jeopardize the achievements of the single market and the customs union.  Others raised concerns about implementation, citing the lack of border controls within the EU.
  • The European Commission has expressed its disappointment over the vote and indicates that it does not plan to withdraw the legislative proposal.  Rather, the Commission intends to engage in further discussion with member states to determine next steps.

FDA stays portions of IND guidance and provides greater flexibility to research health benefits of foods.

  • As a general matter, human clinical research studies to evaluate the therapeutic benefits of a substance are subject to FDA’s Investigational New Drug Application (IND) process.  In September 2013, FDA issued a final guidance document regarding how to determine whether and which human research studies can be conducted without an IND.
  • On October 30, 2015, FDA announced its decision to stay portions of the IND guidance that address conventional foods (related to the study of non-nutritional consumption benefits) and studies intended to support health claims.  The stay of the health claims subsection does not apply to clinical studies that include children under one year of age, people with altered immune systems, or people with serious or life-threatening medical conditions.  FDA has posted a revised copy of the final guidance on its website, indicating clearly those portions subject to the stay.
  • While the partial stay is in effect, researchers who seek to conduct studies to support a new or expanded health claim conducted in healthy individuals over one year of age do not need to obtain an IND.  Similarly, researchers who intend to study non-nutritional effects of conventional foods on the structure or function of the body do not need to obtain an IND.  Overall, the stay gives the industry greater flexibility to conduct research on the beneficial effects of food substances.  According to FDA, the partial stay will serve to encourage scientific research into the relationship between diet and health while the Agency considers comments received in response to the final guidance.

EU considers options to simplify date marking of foods.

  • The European Commission has acknowledged that better understanding and use of date marking codes on food products (e.g., “use by” and “best before” dates) can minimize food waste in Europe.
  • To evaluate this subject, the Commission conducted pan-European quantitative consumer research to assess citizens’ attitudes to food waste and their awareness, understanding, and use of date marking on food products.  The research findings showed that EU consumers generally have difficulty differentiating between “use by” and best before” labeling.  The “use by” date can be found in the EU on products that are highly perishable and susceptible to microbial contamination, and which are likely to pose an immediate danger to human health after a short period of time.  The “best before” date is placed on all other products and consumer judgment is the determining factor in consuming the food once that date has passed.  The study conducted by the Commission showed that misunderstanding of date marking practices leads to an increase in food waste.
  • The Commission is considering possible options to simplify date marking on foods, e.g., expanding the list of foods exempt from the obligation to include a “best before” date or modifying the terminology used in “best before” labeling.  The Commission also has drafted educational materials to improve consumer understanding of existing date marking practices.  The food industry should stay tuned for potential developments in this area in the future.

GMA continues its fight in the GM labeling arena.

  • The effective date for Vermont’s GM labeling law is July 1, 2016.  Absent a federal legislative solution or a victory in the Grocery Manufacturers Association (GMA) challenge to the Vermont law in federal court, the food industry must decide how to comply with the new GM labeling requirements.
  • To provide an update in this area:
    • Although the House passed a GM labeling bill in July that would preempt Vermont’s law (and similar state laws), the Senate has not yet introduced a companion bill.  The Senate Agriculture Committee held a hearing on biotechnology on October 21, at which Sen. Stabenow (D-Michigan) called for a federal legislative solution in the labeling space.  It remains unclear whether such a bill could be passed before the end of the year.
    • On October 8, the Second Circuit heard oral argument in GMA’s First Amendment challenge to the Vermont GM labeling law.  The level of scrutiny to be applied is a pivotal factor in the outcome of this case, and it is not clear that the food industry ultimately will prevail.
  • Food companies continue to face compliance challenges in this area, as many are unsure whether to relabel product on the assumption that the Vermont law will be implemented as planned, or whether to keep holding out hope for a federal fix.  GMA has posted a list of FAQs on its website to clarify its position on GM labeling issues and to summarize the implications of the Vermont law; this resource may serve as a helpful reference to food companies as they attempt to navigate challenges in this area.

Food analytics startup company uses genetic sequencing technology to test hot dog products.

  • The food industry continues to develop new technologies to test for, monitor, and improve product quality and safety.  In some cases, questions about the validity or “fit-for-purpose” nature of specific testing methodologies have sparked debate about the reliance on new technology as a basis for safety concerns, litigation, or enforcement action.  For instance, DNA bar coding made headlines earlier this year when it was used by the New York Attorney General’s office to detect the authenticity of herbal supplements and when published studies indicated its utility in identifying potentially mislabeled meat in the marketplace.
  • A startup testing company claims to have used genomic sequencing technology to detect ingredient substitution, addition, or hygienic issues in a variety of hot dogs sold at retail.  According to its initial report, the company collected 345 hot dog samples across 75 brands sold by 10 retailers.  The report alleges that 14.4% of the samples were “problematic in some way,” including substitution and hygienic issues.  The company also reports that 10% of the “vegetarian” products contained meat and that 2% of the samples contained human DNA.
  • The report concludes with a ranked list of high-scoring brands, a “best of” list, and a series of consumer recommendations.  The food industry likely will need to pay close attention to future developments involving the use of this technology, particularly as it appears poised to generate negative publicity for certain brands on products despite the absence of a clear consensus regarding its validity.

WHO announces causal link between consumption of processed meats and cancer.

  • For years, researchers have debated the link between the consumption of red meat and cancer.  For instance, the American Cancer Society’s position is that some studies indicate “a link” between eating red meat and increased risk of colorectal cancer, but the group has not alleged causation.  The 2010 Dietary Guidelines for Americans state that “moderate evidence” suggested “an association” between increased intake of processed meats and an increased risk of colorectal cancer.
  • On October 26, 2015, the World Health Organization (WHO) announced that, based on a 22-member expert panel’s analysis of more than 800 studies, processed meat (e.g., sausages, bacon) should be classified as “carcinogenic” and red meat should be considered “probably carcinogenic.”  In empirical terms, the WHO’s report states that consuming 50 g of processed meat per day (less than two slices of bacon) increased the risk of developing colorectal cancer by 18%.  This conclusion represents the most definitive and aggressive position taken thus far by any health organization in this arena.
  • Meat industry groups will challenge the WHO’s conclusion, particularly in light of the fact that cancer is a complex disease caused by many factors.  It remains to be seen whether and how the WHO’s aggressive position will affect the statements and recommendations of medical and public health groups going forward.

European Commission publishes roadmap to evaluate regulation on health and nutrition claims.

  • As part of its policy to promote “better regulation,” the European Commission recently announced its plan to evaluate two aspects of Regulation 1924/2006/EC on nutrition and health claims:  (1) nutrient profiles; and (2) the use of claims on plants and their preparations.
  • To this effect, the Commission has published a roadmap describing the steps that the Commission will take in this area and the timeline for the evaluation.  Nutrient profiles are thresholds of nutrients such as fat, salt, and sugars.  If a food exceeds those thresholds, nutrition and health claims are restricted.  The Commission was due to establish the nutrient profiles by January 19, 2009, but this has not yet happened.  Now, the Commission wants to analyze whether such profiles should be established at all.  In the case of claims on plants, the Commission will examine whether the current rules are adequate and will consider how the use of such claims interacts with the current applicable food regulatory framework on plants and their preparations.
  • The Commission is accepting feedback on the roadmap and its structure via a dedicated web page until November 5, 2015.  The roadmap also contemplates two consultations on this topic in the second half of 2016: one of the consultations will be an open public consultation while the other will target stakeholders.  Consumer organizations already have provided feedback strongly criticizing the Commission for announcing the roadmap and calling on the Commission to start developing the nutrient profiles rather than questioning their legitimacy.

FDA reviewing food additive petition to cover limited uses of PHOs.

  • As previously covered on this blog, FDA 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.  Following the Agency’s action, the Grocery Manufacturers Association (GMA) submitted a food additive petition to FDA seeking approval of specific low-level uses of PHOs, up to a maximum consumption level of 1.5% of a person’s daily energy.
  • GMA has indicated that FDA’s formal review of the petition is underway.  The petition seeks approval of low-level uses of PHOs in a variety of food categories including protein drinks, chewing gums, pie fillings, frozen pizza, baked desserts, salad dressings, baking mixes, and shortening, among many others.  A copy of the full petition is available here.
  • Although FDA has given the industry a three-year compliance period in which to remove PHOs from the food supply, questions remain about the legal status of PHOs in food while FDA’s review of the food additive petition is underway.  Keller and Heckman recently hosted a webinar on the impact of FDA’s trans fat announcement on the food industry, focusing in particular on class action lawsuits related to the presence of PHOs in the food supply.  A recording of our webinar (including the slide deck) may be found here.

DMAA still available despite FDA’s “ban.”

  • In 2013, FDA took enforcement actions that resulted in an effective ban on the marketing of DMAA — a stimulant linked to high blood pressure, cardiovascular problems, and even heart attacks.  In taking action against DMAA, FDA specifically noted that it had not undertaken the “lengthy scientific and legal steps” required by law for the Agency to formally ban a compound in a dietary supplement.  Rather, the Agency relied on Warning Letters and facility visits to stop firms from producing and marketing DMAA.
  • Despite FDA’s prior enforcement actions against DMAA, reports indicate that dozens of products containing this controversial ingredient remain available on the market today.
  • According to an FDA spokesperson, the Agency is “following up” on the ongoing availability of DMAA in the marketplace.  It remains to be seen whether FDA will take further direct action against the DMAA-containing supplements, perhaps in the form of additional Warning Letters.  The persistent marketing of this controversial substance calls into question the effectiveness of FDA’s “attempted ban,” as compared to formal regulatory action, like the ephedra ban.