• In a recent proposed statement of decision, LA Superior Court Judge Elihu Berle dealt a blow to Starbucks and a number of other defendants in a case regarding Proposition 65 warnings for acrylamide in coffee, finding that the defense failed to support any of the three criteria necessary to support an alternative significant risk level (ASRL) in lieu of the existing no significant risk level (NSRL) of 0.2 microgram per day.
  • Specifically, Judge Berle held that the defendants failed to (a) establish that acrylamide is created by cooking or processing necessary to render coffee safe or palatable; (b) demonstrate that sound considerations of public health justify applying an ASRL; or (c) present persuasive evidence of what would be an appropriate alternative risk level  (a quantitative risk assessment regarding the risk of developing cancer from exposure to acrylamide in coffee) taking into account public health considerations .
  • Acrylamide is listed as both a carcinogen and reproductive toxicant under Proposition 65.  However, only a warning concerning carcinogenicity has been at issue in this case, presumably because the safe harbor level for reproductive toxicity (i.e., the Maximum Allowable Dose Level) is 140 micrograms per day, much lower than the 0.2 microgram NSRL.
  • On April 2, 2018, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for salmonella. FDA issued the recall after the company failed to cooperate with FDA’s request to conduct a voluntary recall. This is FDA’s first ever mandatory recall.
  • Under the FDA Food Safety Modernization Act (FSMA), FDA has the authority to order the recall of certain food products when FDA determines that there is a reasonable probability that the article of food is adulterated or in violation of certain allergen labeling requirements and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.
  • Mitragyna speciosa, commonly known as kratom, is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. Kratom has opioid properties and stimulant-like effects, and has been marketed in the U.S. to treat muscle pain, diarrhea, and opiate withdrawal. Out of concern for the public health, FDA advises consumers to avoid kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine, in any form and from any manufacturer. The agency also has received concerning reports about the safety of kratom, including deaths associated with its use.
  • Numerous brands of kratom-containing products have been linked to a multi-state outbreak of salmonellosis from multiple strains of salmonella. The FDA continues to advise consumers to avoid kratom and kratom-containing products and discard any in their possession. All salmonella bacteria can cause the foodborne illness salmonellosis, although the strains found related to this recall are not currently linked to the outbreak.
  • China has increased tariffs by up to 25% on 128 U.S. products—including many food products—in response to the increased tariffs on steel and aluminum imports announced by President Trump last month. The new tariffs, effective April 2, include 25% on U.S. pork and 15% on certain wine products, fruits, and nuts. China issued a statement on Sunday, April 1, stating that the new duties are being imposed to safeguard China’s interest and balance the loses caused by the steel and aluminum tariffs, reported Politico.
  • A number of U.S. agricultural trade associations expressed concern over the new tariffs, including those mentioned below.
    • National Pork Producers Council CEO Neil Dierks stated in a press release, “We are disappointed that China has placed an additional 25 percent tariff on U.S. pork exports. Exports are extremely critical to the financial well-being of our producers.”
    • Farmers for Free Trade Co-Chair Max Baucus stated in a press release: “This could be the calm before the storm. While $3 billion in retaliatory tariffs is a major hit, the retaliation expected on agriculture from the 301 trade action could be broader and deeper. Now is the time to deescalate both the trade rhetoric and actions that have brought us to a point where American farmers are being targeted.”
    • “These retaliatory tariffs will disproportionately affect hard-working American pork packers and producers, who will bear the main burden of these measures in the form of lost revenue and restricted market access, particularly as U.S. pork production is slated to rise this year,” Barry Carpenter, president and CEO of the North American Meat Institute, told FOX Business.
    • “The U.S. has made important gains in the Chinese market for a number of fresh produce products. The current proposal by the Chinese government targeting fresh fruit with retaliatory tariffs hurts farmers and businesses and is counterproductive to the growth of our export efforts,” Robert Guenther, senior vice president of public policy at the United Fresh Produce Association, told FOX Business.
  • The U.S. sent more than $21 billion worth of agricultural exports to China in 2016, including $578 million worth of pork products, according to the U.S. Department of Agriculture.
  • In a March 29, 2018 press release, the Food and Drug Administration (FDA) announced a consent decree entered by the US District Court for the Eastern District of New York for a permanent injunction against Riddhi USA and its owner, Mohd M. Alam.  Riddhi USA (which is not currently manufacturing dietary supplements) is a New York based wholesale manufacturer and distributor of dietary supplements.  The permanent injunction requires the defendants to cease directly or indirectly manufacturing or distributing dietary supplements.
  • In 2016, the FDA issued a warning letter to Riddhi USA after a facility inspection identified violations of good manufacturing practice regulations and for failing to declare all ingredients on the products’ labels.
  • Last year, Riddhi USA was charged with violating the Federal Food, Drug, and Cosmetic Act because their products were prepared, packed or held in violation of current good manufacturing practice regulations (cGMP).  The violations included failing to establish product specifications for the identity, purity, strength and composition of the finished dietary supplements; inadequate master manufacturing and batch production records; lack of quality control procedures; and lack of procedures to investigate product complaints.  Additionally, the products’ labeling failed to declare dietary ingredients, allergens and the manufacturer’s place of business.
  • Should Riddhi USA or Mr. Alam wish to begin manufacturing again, the consent decree prohibits Riddhi USA from receiving, processing, manufacturing, preparing, packing, holding and distributing dietary supplements until they hire an expert to ensure that they are following all cGMP regulations and following an inspection, receive FDA approval to resume operations.
  • On March 16, 2018, FDA issued a warning letter to Bhavani Fruits and Vegetables LLC in Maspeth, New York for “serious violations” of Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 117.  We believe this is the first instance in which FDA has formally cited Part 117 CGMP regulations promulgated under FSMA in a warning letter (as opposed to Part 110 CGMP regulations that preceded FSMA).
  • The date for compliance with the revised CGMP regulations for large businesses (with at least 500 full-time equivalent employees) on was September 19, 2016 and for small businesses (businesses with fewer than 500 full-time equivalent employees) was September 18, 2017.  The compliance date for very small businesses (businesses averaging less than $1 million per year (adjusted for inflation) in annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale) is September 17, 2018.
  • For several months, FDA’s Warning Letters have included a footnote noting that the old food CGMP regulations (21 CFR Part 110) had been modernized under Part 117 and that an “establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size.”  FDA continues to use this footnote in warning letters, including a March 21, 2018 warning letter to Starlight Desserts Inc.  (It is not clear whether Starlight Desserts is a very small business not yet subject to mandatory CGMP regulations.)  In light of the Bhavani Fruits and Vegetables warning letter, we expect to see more citations to Part 117 CGMP violations in future warning letters.
  • In the March 28, 2018 FDA Voice blog  Dr. Gottlieb provided background and insight on the Intentional Adulteration rule.
  • The FDA Food Safety Modernization Act (FSMA) charges FDA with addressing the burden of foodborne illness by requiring that producers, importers and distributors of food take systematic steps to prevent contamination. Congress passed FSMA with a view of the unique risks posed by a global food supply. Six of FDA’s seven “foundational rules” for FSMA focus on the safe production, storage, and transport of human and animal food by addressing conventional food safety hazards.  But a different reality shapes the seventh rule on intentional adulteration. This provision seeks to prevent acts of terrorism meant to harm and kill many people.  For more background see the Daily Intake blog posts here and here.
  • Extensive analysis shows that some of the most significant risks are posed by an attack perpetrated by someone who has legitimate access to a facility.  Though unlikely, such adulteration is a legitimate concern.  For example, there was a recent report of a foiled terror plot in the United Kingdom that involved an employee at a food manufacturing plant who had been investigating ways to poison supermarket-ready foods.
  • FDA intends to issue a guidance well in advance of the 2019 compliance date.  The guidance will publish in three installments, the first coming in the near future.
    • The first installment will include a simple, cost-effective way to identify the most vulnerable parts of the production process. It will detail numerous ways to guard against deliberate contamination, including some existing and cost-effective measures, as well as additional ways to monitor the operation to make sure that protections are working.
    • The second installment will include guidance on an additional, detailed, and flexible method to identify a facility’s most vulnerable points.
    • The third installment will focus on corrective actions, verifying that the system is working, how to reanalyze the plan and its parts, and record keeping.
  • The Daily Intake blog will continue to monitor this guidance.  We will alert our readers as more information becomes available.
  • On March 22, 2018, Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition, addressed the audience at the Future Food-Tech Summit about FDA’s role in supporting innovation in food technology. Dr. Mayne divided her talk into four key questions:

(1) How can food-tech innovators get the support and information they need from FDA to bring a product to market that is safe and lawful?

(2) What is the thought process behind the regulation of composition, quality, safety and labeling of foods?

(3) How can regulatory bodies and food-tech innovators better collaborate to achieve greater success in scaling truly innovative solutions?

(4) How is the convergence of biotech and digital technologies shaping the future of food?

  • Throughout her speech, Dr. Mayne highlighted the importance of consulting FDA early in the process – “We can provide feedback that will give you a better understanding of what regulations you’ll be required to meet as you move forward to bring your product to market.” One example cited was FDA’s voluntary consultation process to engage with the developers of foods derived from genetically engineered plants. This process helps developers determine the necessary steps to ensure the resulting food products are safe and lawful.
  • Dr. Mayne endorsed FDA’s guidance documents as good sources of information about regulatory requirements, and stressed the importance of food safety, stating it must be part of a food innovator’s mission – “It’s our mission to protect public health and we are on board with supporting innovative products, but they must be safe products.”
  • Dr. Mayne concluded her talk by quickly mentioning FDA’s update to the Nutrition Facts label. “We know that consumers are demanding healthier foods, and industry, including many of your companies, is seeking new ways to deliver products that meet consumer needs. […] I encourage you to work with FDA, to bring your brainpower and imagination to the challenge of feeding the world, helping people have healthier diets, and providing innovative new options for consumers.”
  • As previously reported on this blog, the National Marine Fisheries Service’s (NMFS) National Oceanic and Atmospheric Administration (NOAA), Commerce Department, issued a final rule on December 9, 2016 (81 FR 88975), that established the Seafood Import Monitoring Program (SIMP). The goal of the program is to prevent illegal, unreported, and unregulated (IUU) seafood from entering U.S. commerce.
  • SIMP established data reporting and recordkeeping requirements for imports of certain priority fish and fish products. Abalone, several types of cod and tuna, red snapper, Blue and King Crab, sharks, shrimp, and swordfish are among the types of seafood that were identified as being especially vulnerable to seafood fraud. The compliance date for most priority species was January 1, 2018. However, an administrative stay was placed on implementation for shrimp and abalone due to concerns over consistency with World Trade Organization (WTO) rules.
  • In February 2018, a bipartisan group of 11 senators sent a letter to Senators Thad Cochran (R-MS) and Patrick Leahy (D-VT) requesting that the FY18 Commerce, Justice, Science, and Related Agencies appropriations bill include language to ensure that SIMP include shrimp within 30 days of enactment of the bill. The senators raised concerns about the use of antibiotics in some imported shrimp and suspect labor violations that produce some imported shrimp.
  • The FY 2018 Omnibus appropriations bill includes a provision that gives NMFS until the end of 2018 to apply SIMP to shrimp and abalone. The legislation also includes provisions concerning the domestic production of farmed shrimp that will ensure consistency with WTO rules, reports the Southern Shrimp Alliance (SSA). Shrimp is the largest U.S. seafood import, with over $6 billion in shrimp products imported in 2017, according to SSA.

2nd Cir. Affirms Dismissal of Organic Baby Food Claims (subscription to Law360 required)

  • The U.S. Court of Appeals for the 2nd Circuit ruled against plaintiffs in Marentette v. Abbott Laboratories, Inc., Case No. 17-62, Decided: March 23, 2018, affirming the lower court’s dismissal of claims that Abbott’s organic-labelled infant formula violate state law by including ingredients that are not permitted under the Organic Food Production Act (OFPA).  The 2nd Cir. agreed with the decision of the 8th Circuit in In Re Aurora Dairy Corp. Organic Milk Marketing, 621 F. 3d. 781 (2010) that all state-law claims which effectively challenge an OFPA organic certification are barred by conflict-obstacle preemption principles and found there would be no way to rule in plaintiffs’ favor without contradicting a lawful OFPA organic certification decision. 
  • Conflict-obstacle preemption is a form of implied preemption of state law by federal law (i.e., preemption is not expressly stated).  It applies where the state law at issue would stand as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.  The Abbott court and the Aurora court have found that where determining whether plaintiffs have a meritorious state law claim would require looking behind an organic certification that is properly granted under the OFPA, those state law claims are an obstacle to the federal scheme’s objectives and are preempted. 
  • The Abbott court’s decision reinforces that products certified organic pursuant to OFPA are organic as a matter of federal law and there is no distinction between federal law compliance versus certification. 

 

 

 

  • Over the last year, dairy industry groups have appealed to FDA and Congress to enforce the standard of identity for milk with regard to plant-based beverages labeled as “milk,” for example “soy milk”.  The dairy industry argues that milk is defined as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows” (21 C.F.R. Section 131.110) and that plant-based beverages do not meet this standard.  Those wishing for plant-based beverages to retain the ability to use a name including the plant source and the word “milk” argue that such a name provides context for consumers while making the plant-based origins of the beverage clear.  See Daily Intake posts on the topic here, here, and here.
  • Now,  the rice industry is interested in ending the practice of naming vegetables that have undergone a process known as ricing from being labeled as “rice” preceded by the vegetable type, for example “cauliflower rice.”  The industry argues that the use of the term rice is misleading to consumers who might expect the vegetable rice product to contain Oryza sativa L. or wild rice defined by the four species of grasses from the genus Zizania.  See our blog post on the topic from May 2017.
  • Arkansas, a major producer of rice in the United States, recently passed a resolution to set a standard for rice, urged Federal regulators to set a standard for rice,  and take action against vegetable rice products that do not contain any Oryza sativa L. or wild rice.
  • If a federal standard of identity for rice is established, the argument that riced vegetables cannot use rice in their names would be strengthened.  The battle over whether plant-based beverages can include “milk” in their names will be predictive, especially if plant-based beverages are allowed to continue using “milk” in their names.