New Chinese food safety law took effect on October 1, 2015.

  • On October 1, 2015, China’s Food Safety Law (FSL) took effect.  As the fundamental law regulating food safety in China, the revised FSL provides the basic legal framework for food safety supervision and management.
  • The law is being implemented via regulations and national food safety standards promulgated by the National Health and Family Planning Commission (NHFPC), China Food and Drug Administration (CFDA), and General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), among other administrative agencies.
  • Keller and Heckman’s Shanghai office has analyzed the FSL and its implications for the food industry in the following article, published in the National Law Review:  “China’s Food Safety Law Takes Effect Today: Are You Ready?”

Bayer prevails over FTC in case addressing claim substantiation for dietary supplements.

  • In the dietary supplement advertising area, the Federal Trade Commission (FTC) takes enforcement action where companies lack “competent and reliable scientific evidence” to substantiate marketing claims.  In 2014, the FTC initiated civil contempt proceedings against Bayer related to claims for a probiotic supplement, alleging that the company violated a 2007 consent decree by making unsubstantiated claims about the product’s role in alleviating gastrointestinal symptoms.  During the ensuing trial, the FTC opined that the “competent and reliable scientific evidence” required to support Bayer’s claims necessitated a randomized controlled trial (RCT), i.e., the “gold standard” for claims in the pharmaceutical area.
  • The U.S. District Court for the District of New Jersey has ruled in Bayer’s favor, finding that the company made appropriate structure-function claims (rather than disease claims) and that one government expert’s opinion was insufficient to establish the requirement that only an RCT could substantiate the claims.
  • Particularly because a win for the government in this case could have imposed RCTs as the new minimum requirement to substantiate structure-function claims, Bayer’s victory is being hailed as a positive outcome for the food and supplement industry.

K&H publishes summaries of FSMA final HARPC rules for human food and animal food.

  • As promised, Keller and Heckman LLP has prepared summaries of FDA’s final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions for human and animal food under the FDA Food Safety Modernization Act (FSMA).
  • Click here for our summary of the final human HARPC rule.
  • Click here for our summary of the final animal HARPC rule.

Stay tuned for our upcoming complimentary webinar to summarize the implications of these rules for the food industry, focusing on both food processors and ingredient suppliers.

The Daily Intake will be on hiatus during our Practical Food Law Seminar — we will return on Friday, October 2.

Vermont issues guidance on GM labeling regulations. 

  • Pending the outcome of the ongoing legal challenge to Vermont’s GM labeling law, the law and its implementing regulations are set to take effect on July 1, 2016.
  • On September 23, 2015, the Vermont Attorney General’s Office issued guidance on the state’s interpretation and planned enforcement of the labeling requirements.  Formatted as an annotated version of the regulatory text, the guidance indicates the origin of various definitions and provides illustrative examples of how specific requirements and exemptions may function in practice.  The guidance also provides detailed information regarding the records that will be sufficient to demonstrate compliance with the state’s requirements.
  • Oral argument in the food industry’s challenge to the constitutionality of Vermont’s GM labeling law is scheduled for October 8 before the Second Circuit Court of Appeals.  In the meantime, food manufacturers remain stuck between a rock and a hard place — preparing for compliance, while hoping for relief.

California abandons “zero-tolerance” approach to foreign content in products bearing “Made in USA” claims.

  • As previously covered on this blog, a product may bear a “Made in USA”-type (MIU) claim in accordance with federal guidelines where “all or virtually all” of the product is made in the U.S.A.  In contrast, California’s MIU standard has been much stricter, prohibiting such claims if any unit or part of the product has been entirely or substantially made outside of the U.S.A.  Major lawsuits have been filed based on allegations that components or ingredients of manufactured products bearing MIU claims came from foreign sources, in violation of the “zero-tolerance” policy.
  • California has enacted new legislation to revise its decades-old approach to MIU claims.  Under the new standard, products bearing MIU claims generally may contain up to 5% foreign content (measured as a percentage of the final wholesale value of the manufactured product).  Products may contain up to 10% foreign content where the manufacturer can show that it can neither produce nor obtain the foreign-sourced components within the United States.
  • California’s new standard is more akin to the Federal Trade Commission’s “all or virtually all” standard, although with the added benefit of quantitative thresholds for how much foreign content is permitted.  In practice, it is not clear whether the new thresholds — which are fairly stringent themselves — will provide significantly greater flexibility to most domestic manufacturers.  Nevertheless, California’s abandonment of its “zero-tolerance” standard is being received positively by the industry and is likely to resolve a number of questions, issues, and challenges that pit the prior standard against the more flexible federal scheme.

NSF International announces new Non-GMO certification program.

  • As the food industry knows, “Non-GMO” claims — i.e., claims advertising the non-use of genetic modification (GM) in food production — have become popular and desirable from a marketing standpoint, despite the lack of any clear regulatory definition or oversight of such claims.  The Non GMO Project has been a leader in the claim certification space, with their logo appearing on numerous products in the marketplace.
  • NSF International has announced the launch of a new certification program called “True North.”  According to the company, True North incorporates elements from GM labeling regulations worldwide (including EU and Vermont requirements).  It also takes into account practices such as segregation, traceability, and supplier approval and monitoring programs.  Further, the program requires unannounced audits, unannounced chain of custody sampling, and independent testing calibrated to risk level.  Manufacturers also must perform routine product testing.
  • Much remains unsettled in terms of GM labeling regulations in the U.S.  With the status of the Vermont law still under debate and the House-passed GM bill stalled, the future of “Non-GMO” claims and private certification programs is unclear.  If the House GM bill ultimately becomes law, the U.S. Department of Agriculture (USDA) will begin administering a voluntary “Non-GMO” claim certification program (akin to the organic labeling regime), which could significantly undercut the market desirability and value of private certification programs.

Former Peanut Corporation of America owner receives 28-year prison sentence.

  • As previously covered on this blog, the 2008-2009 Salmonella outbreak linked to peanut products distributed by Peanut Corporation of America (PCA) was one of the deadliest outbreaks in modern history.  The government brought a criminal prosecution against PCA executives and employees, alleging that they had knowingly introduced tainted food into interstate commerce.  In May 2015, a judge upheld convictions for Stewart Parnell (former PCA owner), Michael Parnell (former peanut broker), and Mary Wilkerson (former quality control manager).
  • On September 21, 2015, the three defendants were sentenced to prison.  Stewart Parnell received a groundbreaking 28-year sentence.  Michael Parnell and Mary Wilkerson received sentences of 20 years and 5 years, respectively.
  • The PCA saga and Stewart Parnell’s severe penalty highlight the significant costs and consequences that may be associated with the failure to address and contain a food safety problem.  Especially now that FDA has finalized rules to implement key food safety requirements under the FDA Food Safety Modernization Act (FSMA), we expect that food safety will have the attention of corporate executives and boardrooms for quite some time to come.

DOJ indicates “illegal activity in the dietary supplement industry” as a high priority.

  • The dietary supplement industry has had its share of negative publicity in 2015, ranging from the New York Attorney General’s investigation into allegedly mislabeled herbal products, to FDA enforcement actions against BMPEA and DMBA, to a recent facility shutdown.  In May 2015, Senators Hatch (R-Utah) and Heinrich (D-New Mexico) wrote a letter to U.S. Attorney General, Loretta Lynch, expressing their concern about alleged “criminal activity” in the dietary supplement domain, specifically with respect to the marketing of supplements that contain anabolic steroids or active pharmaceutical ingredients and their analogues.
  • Recently, the Department of Justice (DOJ) responded to the Senators’ letter.  The letter reportedly indicates DOJ’s awareness of illegal activity in the supplement marketing arena and puts combating such activity “high on the [DOJ’s] priority list.”
  • Major dietary supplement trade associations have issued positive responses to the letter, reiterating that the majority of companies in this area are law-abiding and responsible.  It remains a continuing challenge for the supplement industry to work with regulators to uphold the reputation of good companies and safe products amid negative publicity that threatens to tarnish the industry as a whole.

THIS WEEK:  Keller and Heckman is hosting an intensive one-day seminar in New York City on September 24, 2015 to discuss food authenticity issues, particularly with respect to Extra Virgin Olive Oil.  Event details and registration information are available here.

Federal government announces goal to reduce food waste. 

  • Food waste is a major issue in the United States, with the U.S. Department of Agriculture (USDA) estimating that Americans waste 133 billion pounds of food each year, or 31% of the overall food supply.  The Environmental Protection Agency (EPA) estimates that 21% of all the waste in landfills is food.
  • USDA has joined forces with EPA to announce the nation’s first-ever food waste reduction goal — a 50% reduction in food waste by 2030.
  • To further the waste reduction effort, the federal government intends to partner with charitable organizations; faith-based organizations; the private sector; and local, state, and tribal governments.  Specific to the private sector, USDA and EPA are calling on entities such as food service companies, institutions, restaurants, and grocery stores to target and implement their own aggressive goals for reducing food waste in the months and years ahead.

Federal Register publications available for final rules to implement FSMA HARPC provisions for human and animal food.

  • On September 10, 2015, FDA issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions under the FDA Food Safety Modernization Act (FSMA).
  • On September 17, 2015, the final rules were published in the Federal Register.
    • Click here for the Federal Register publication of the final human HARPC rule (80 Fed. Reg. 55908).
    • Click here for the Federal Register publication of the final animal HARPC rule (80 Fed. Reg. 56170).
  • Companies generally must comply with the requirements of the human HARPC rule by September 19, 2016.  For the animal HARPC rule, companies generally must comply with the Current Good Manufacturing Practice (CGMP) requirements by September 19, 2016, and with the HARPC requirements by September 18, 2017.  Both rules provide later compliance dates for small and very small businesses, for certain types of facilities (e.g., qualified facilities, facilities subject to the Pasteurized Milk Ordinance (for human HARPC rule)), and for certain provisions (e.g., the supply-chain program).  Additional detail regarding compliance dates is available on page 56128 of the preamble to the human HARPC rule and on page 56329 of the preamble to the animal HARPC rule.

Keller and Heckman LLP is preparing full analyses of both final rules and will host a complimentary webinar in the near future to summarize the implications of these rules for the food industry, focusing on both food processors and ingredient suppliers.