USDA-NIFA provides grants to establish two regional food safety centers.

  • As previously covered on this blog, FDA recently released its FSMA Training Strategy, indicating the Agency’s roadmap for facilitating industry training and thus promoting effective implementation of the FDA Food Safety Modernization Act (FSMA).  As part of its plan FDA is partnering with the U.S. Department of Agriculture’s National Institute of Food and Agriculture (USDA-NIFA) to provide grants to fund a National Coordination Center (NCC) and four Regional Centers (RCs) to provide training opportunities for owners and operators of farms, small food processors, and small fruit and vegetable merchant wholesalers.
  • USDA-NIFA now has announced the issuance of more than $2 million in grants to the University of Florida in Gainesville and Oregon State University in Corvallis to establish two RCs to support comprehensive food safety training and education.
  • The two RC grants follow FDA’s award of the NCC grant to the International Food Protection Training Institute in Battle Creek, Michigan.  The FDA-funded NCC will coordinate the overall food safety program, while the RCs will serve at the local community level, working with FSMA stakeholders across the country.  Although full implementation likely will take some time, FDA and USDA-NIFA activities to date indicate a continuing commitment to federal partnerships aimed at promoting effective FSMA implementation.

CFS report addresses use of animal drugs in livestock farming.

  • The ongoing discussion about the use of antibiotics in farming has received renewed interest in light of recent actions by FDA and the state of California to curb routine antibiotic use.  Although recent regulatory and legislative action has focused primarily on antibiotics, other classes of drugs play a role in present-day agricultural practice.
  • A consumer safety group, the Center for Food Safety (CFS), has released a report intended to raise awareness about the use of various animal drugs in farming.  Specifically, the report addresses beta-agonists; antibiotics; steroid hormones; arsenicals (which will no longer be approved for use in animal feed); antioxidants; and cocciodiostats, concluding with a recommendation that FDA re-evaluate the safety of the use of these drugs in livestock farming and consider regulatory action to limit such use.  The report also urges states and localities to take action in this area, and encourages consumers to continue to apply market pressure.
  • The CFS report suggests that recent actions to limit the use of antibiotics may spur an increase in the use of other drugs used for growth promotion, although no data are provided to support this assertion.  The impact of this report remains to be seen, but it raises the question of whether stricter antibiotic regulation is just the first wave in reforming the use of animal drugs in modern farming, and if so, which drug class will be the next target?

New England Journal of Medicine analyzes ER visits in United States linked to dietary supplements.

  • A significant percentage of the U.S. population consumes dietary supplements — a product category that encompasses a wide variety of products such as vitamins, minerals, herbs and botanicals, and amino acids.
  • An article published in the New England Journal of Medicine analyzed a data set to estimate that approximately 23,000 ER visits per year (and over 2,000 hospitalizations) were attributable to adverse events related to dietary supplements, with “herbal or complementary nutritional products for weight loss…and increased energy” commonly implicated.  The analysis is based on statistics from 63 emergency departments during the 2004 to 2013 time frame, and not on FDA’s Serious Adverse Event Reporting database for dietary supplements.
  • The broader implications of this analysis are questionable.  First, a CDC estimate suggests that there are 136.3 million ER visits per year; thus, an estimated 23,000 visits related to supplements represent an insignificant fraction of that total.  Further, industry stakeholders cite critically the researchers’ failure to assess the severity of the adverse events that triggered ER visits and the incorrect classification of products as dietary supplements (e.g., ear drops, eye drops, OTC products).  This report suggests continued scientific and journalistic interest in the general safety of dietary supplements, but its utility may be quite limited due to the host of variables and factors that were not considered or explained in the overall assessment.

European Parliamentary Committee rejects bill that would allow countries to restrict or ban use of imported GM crops with EU approvals.

  • 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.  In the aftermath of this legislation, a majority of EU member states requested to “opt out” of GM cultivation in all or part of their territories.
  • The Environment Committee of the European Parliament has rejected draft legislation (by a vote of 47-3) that would have permitted countries to restrict the use of imported GM crops that have been approved at the EU level.  Unlike the case of GM cultivation — where only one crop has been approved for cultivation in the EU to date — more than 60 GM crops have been approved for import.  These approvals cover both human and animal consumption, although most applications involve animal feed uses.
  • The full Parliament is set to vote on the draft legislation on October 28.  Industry stakeholders encourage continued opposition of the bill due to its potentially significant negative impact on trade within the EU bloc.

California passes legislation to curb use of antibiotics in livestock.

  • As previously covered on this blog, concerns about the use of antibiotics to promote growth or feed efficiency in food-producing animals continue to proliferate.  FDA has requested voluntary industry efforts to reduce the use of antibiotics in livestock and has proposed to expand data collection in this area.  FDA also has issued a final rule requiring veterinary supervision of antibiotic use in food-producing animals.
  • California now has passed legislation to curb the use of antibiotics in livestock.  Consistent with federal actions in this area, the state law requires a veterinarian’s prescription to permit the use of medically important antibiotics in livestock and prohibits the use of such antibiotics solely for purposes of promoting weight gain or improving feed efficiency.  The law also requires state agencies to collaborate in developing a monitoring program to evaluate information regarding the use of medically important antibiotics, antimicrobial resistance, and livestock management practices.
  • California has become the first state in the U.S. to ban the routine use of antibiotics in livestock.  The legislation received little to no opposition from state meat and poultry associations, which is indicative of its consistency with existing efforts to phase out antibiotics.  Particularly in light of recent high-profile announcements by major restaurants and suppliers to stop selling chicken raised with antibiotics, it appears that marketplace pressures will continue to work in conjunction with federal, state, and industry efforts to curb antibiotic use.

FDA suggests willingness to acknowledge dietary supplement GMP compliance and hints that revised NDI draft guidance may be coming soon.

  • FDA has regulatory authority over dietary supplements and dietary ingredients.  In recent years, the industry has grappled with negative publicity regarding compliance with the dietary supplement good manufacturing practices (GMPs) set forth in 21 CFR Part 111.  The industry also has faced significant confusion in the aftermath of FDA’s issuance — and subsequent informal withdrawal — of a 2011 draft guidance document regarding notification requirements for new dietary ingredients (NDIs).
  • At a recent meeting hosted by a dietary supplement trade association, the American Herbal Product Association, the acting deputy director of FDA’s Division of Dietary Supplement Programs, Dr. Cara Welch, indicated some upcoming changes and developments of relevance to the supplement industry.  Regarding GMP compliance, Dr. Welch stated that FDA plans to begin highlighting positive examples of supplement GMP compliance as part of its efforts to monitor and incentivize compliance.  Rather than focusing solely on the industry’s alleged shortcomings, FDA plans to begin identifying and highlighting “the good players.”  Regarding the NDI draft guidance, Dr. Welch indicated her hopes that a revised document can be released “soon” and noted that re-issuance of the document will reopen the comment period.
  • Both a shift in FDA’s GMP publicity policy and new insight into FDA’s views regarding the regulation of NDIs will be of significant interest to the dietary supplement industry.  However, because FDA’s dietary supplement division has only 26 full-time employees — a figure that Dr. Welch does not anticipate will change in the near future — it remains to be seen how quickly these developments actually will materialize.

Consumer advocacy group sues FDA to compel Agency action on sodium.

  • Sodium reduction has been a hot topic for many years, with average dietary intakes remaining higher than the recommended value of 2,300 mg/day (or 1,500 mg/day for certain at-risk groups).  The food industry has embarked on voluntary efforts to reduce sodium levels in processed foods, but some stakeholders feel that this initiative has fallen short.
  • The Center for Science in the Public Interest (CSPI) has now sued FDA to compel action on a 2005 Citizen Petition requesting that the Agency revoke the conclusion that salt is generally recognized as safe (GRAS); reduce the amount of sodium in processed foods; and require a health warning on packaged salt.  The complaint alleges that FDA’s failure to act on the Citizen Petition violates the Administrative Procedure Act (APA).
  • Although FDA has given no indication that it plans to take drastic regulatory action to address the level of sodium in the food supply, CSPI’s lawsuit comes on the heels of New York City’s first-in-nation sodium warning requirement for restaurant foods and FDA’s relatively recent revocation of the GRAS status of partially hydrogenated oils (PHOs).  The nation also is awaiting the release of the 2015 Dietary Guidelines for Americans (DGA), which will include sodium intake recommendations.  It is not clear that any of these actions or events will influence FDA action on sodium.  Nevertheless, CPSI’s lawsuit comes at a time when the debate over sodium and the use of GRAS determinations as a public health tool both are active topics; it is clear that this particular policy conversation is far from over.

2015 Dietary Guidelines for Americans will not include “sustainability.”

  • The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) are working to finalize the 2015 Dietary Guidelines for Americans (DGA) — a set of recommendations based on up-to-date nutrition science that is intended to help the U.S. population make healthy food and beverage choices.  In February 2015, the Dietary Guidelines Advisory Committee submitted a report to HHS and USDA, including the controversial recommendation that Americans should eat a less resource-intensive diet with a greater emphasis on plant-based foods and decreased emphasis on red and processed meats.
  • HHS and USDA now have confirmed that sustainability will not factor into the 2015 DGA.  While acknowledging the importance of considering the environmental impact of food sources, the government has indicated that sustainability issues fall outside the scope of the DGA and that nutrition recommendations are not the appropriate vehicle for this particular policy conversation.
  • The decision to exclude sustainability from the DGA generally is being met with praise from the food industry, as many believe that nutrition scientists do not possess the right expertise to evaluate environmental policy issues.  Regardless of its omission from the DGA, however, the conversation about sustainability is likely to remain active in today’s environment and marketplace.

FDA shares its strategy for FSMA training.

  • Implementation of the FDA Food Safety Modernization Act (FSMA) is well underway.  FDA has finalized two major rules to implement hazard analysis and risk-based preventive controls (HARPC) for human and animal food, and final rules to implement the produce safety standards, foreign supplier verification program (FSVP), and third-party accreditation program are expected at the end of this month.  To ensure compliance with all FSMA requirements, food industry employees must be appropriately trained.
  • FDA has released its FSMA Training Strategy, indicating the Agency’s plan to facilitate industry training and thus promote effective FSMA implementation.  The Produce Safety Alliance (PSA), Food Safety Preventive Controls Alliance (FSPCA), and Sprout Safety Alliance (SSA) — which include federal and state agency officials, food industry members, and academics — are developing training programs to help the industry understand HARPC requirements and the forthcoming produce safety standards.  FDA also plans to issue guidance detailing the core criteria, learning objectives, and elements recommended for FSMA training programs.  The Agency is partnering with the U.S. Department of Agriculture’s National Institute of Food and Agriculture (NIFA) to coordinate training programs and opportunities for operators of farms, small food processors, and small fruit and vegetable merchant wholesalers.
  • It likely will take significant time and coordination before FDA’s FSMA Training Strategy is up and running.  Nevertheless, the strategy indicates the Agency’s understanding that partnerships and collaboration are essential to facilitate the broad array of training programs that will be needed to implement FSMA.

Judge dismisses majority of claims in class action lawsuit due to implausible assertions by plaintiff. (subscription to Law360 required)

  • As the food industry is well aware, the “Food Court” (i.e., the Northern District of California) handles a significant amount of litigation related to “natural” claims and other food marketing and advertising issues.  In one recent example, Whole Foods is facing a proposed class action lawsuit premised on allegedly misleading “natural” claims.  The plaintiff also accused Whole Foods of misleadingly using the term “evaporated cane juice” (ECJ) to make products containing an added sugar seem healthier.
  • Citing implausible assertions by the plaintiff, the judge now has dismissed all claims related to ECJ.  Specifically, the judge criticized the plaintiff’s assertions that:  (1) he was unaware that ECJ was a sweetener; (2) he believed ECJ was healthy because the “j” stands for “juice”; and (3) he knew ECJ was a sweetener (inconsistent with the first assertion), but thought it was a type of “healthy unrefined sugar.”  According to the judge, none of these theories was “well-pled or plausible under the ‘reasonable consumer’ test.”  Particularly since the plaintiff was a self-styled “health conscious consumer who wished to avoid ‘added sugars,'” the judge found the inconsistencies in his statements and actions sufficient enough to warrant dismissal of the claims.
  • Although the “natural” claim challenge still survives, this partial dismissal indicates the court’s analysis of the reasonableness, consistency, and plausibility of a plaintiff’s assertions under the circumstances.  As was the case with “serial plaintiffs,” perhaps self-styled “health conscious” plaintiffs will find less sympathy from the bench when their purchasing decisions are inconsistent with their professed lifestyle choices.