• On April 24, 2018, FDA announced its Youth Tobacco Prevention Plan to stop adolescent use of, and access to, vapor products.  FDA followed up on its announcement by issuing 17 warning letters for marketing e-liquids in allegedly misbranded and misleading packaging found  to be appealing to youth.  In September, FDA announced that it has issued 1,300 warning letters and imposed civil penalties for sales of cartridge-based e-cigarettes.  Also in September, FDA requested information within 60 days from JUUL Labs, and four other cartridge-based e-cigarettes, regarding how they will curb youth use.  FDA has threatened to remove flavored e-liquids from the market to prevent youth uptake.
  • On Tuesday October 2, FDA confirmed that it had inspected JUUL Labs on Friday September 28, obtaining more than 1,000 pages of records on marketing.  Kevin Burns, CEO of JUUL Labs, issued a statement that JUUL has released over 50,000 pages of documents to FDA since April in support of its position that it markets only to adults.
  • Keller and Heckman’s Tobacco and E-Vapor practice has covered FDA’s Youth Tobacco Prevention Plan extensively on The Continuum of Risk Blog.  As our colleagues point out, the majority of youth use is via cartridge-based e-cigarette but a flavor ban could destroy the vapor industry.
  • Two prominent e-vapor trade associations, American E-Liquids Manufacturing Standards Association (AEMSA) and the Smoke-Free Alternatives Tobacco Association (SFATA), jointly developed a youth prevention program, the Youth Education, Protection, and Prevention (YEPP) program. The YEPP program includes (1) youth education about the dangers of vaping and material discouraging vaping by young people, (2) parental education to identify the signs of youth vaping and use of vapor products,  (3) tools to help parents talk with their kids about vaping, and (4) retailer training to prevent minor sales.
  • Eighteen companies voluntarily participating in the Better Business Bureau’s (BBB’s) Children’s Food and Beverage Advertising Initiative (CFBAI) have updated the group’s 2011 Uniform Nutrition Criteria for foods and beverages advertised to children under 12.  Participants in the CFBAI include leading quick service restaurants, confectionery manufacturers, processed food companies, and ingredient manufacturers.
  • CFBAI members have committed since 2011 to advertising to children under 12 only those foods that meet the group’s Uniform Nutrition Criteria.  According to its 2018 White Paper, the group has developed stricter requirements (as compared to the 2011 criteria) for a number of nutrients, including sodium and added sugar.  For example, under the new criteria, fruits and vegetables that were previously exempt will need to meet “no added sugar” and “very low sodium” requirements when in canned or frozen form.  In addition, the limit on sodium in savory snacks is decreasing from 290 mg to 260 mg per serving .
  • CFBAI estimates that 40% of the products that met its 2011 Uniform Nutrition Criteria will not meet the new criteria, which were revised following the release of the 2015-2020 Dietary Guidelines for Americans and FDA’s updated Nutrition Facts regulations.   The new Uniform Nutrition Criteria are summarized here.  The implementation date is set for January 1, 2020, which is also the compliance date for FDA’s new Nutrition Facts and serving size regulations.
  • On October 1, 2018, the U.S. Food and Drug Administration (FDA) released a report showing the majority of human and pet foods produced and imported into the U.S. during FY 2016 tested below the federal limits for pesticide chemical residues. FDA tested for 711 pesticides and industrial chemicals in 6946 human food products and 467 animal foods during the fiscal year running from Oct. 1, 2015 to Sept. 30, 2016 under the FDA’s Pesticide Monitoring Program. For human food products, FDA found that over 99% of domestic and 90% of import human foods were compliant with federal standards. Further, no pesticide chemical residues were found in 52.9% of the domestic and 50.7% of the import samples that FDA analyzed.
  • FDA also publicized the findings of its “Collection of Selected Domestic and Imported Foods for Herbicides Analysis” study that examined residues of glyphosate, glufosinate, and 30 selected acid herbicides in foods.  Glyphosate, the active ingredient in popular garden weed killers and one of the most-used agricultural chemicals in the world, has been the subject of much controversy. As previously reported on this blog, on August 10, 2018, a San Francisco jury awarded a former school groundskeeper dying of non-Hodgkin’s lymphoma $289 million against Monsanto for claims that the Roundup herbicide was a substantial contributing factor in causing his cancer.
  • Analyzing 274 grain corn, 267 soybean, 113 milk, and 106 egg samples, FDA found non-volatile levels of glyphosate in 63.1% of corn samples and 67% of soybean samples. Non-volatile levels of glufosinate were found in 1.4% of corn tested and 1.1% of soybeans. In a statement accompanying the release of the results, FDA Commissioner Scott Gottlieb said, “…the results show that overall levels of pesticide chemical residues are below the Environmental Protection Agency’s tolerances, and therefore don’t pose a risk to consumers.”
  • As previously reported on this blog, the European Court of Justice ruled that all techniques that induce DNA mutagenesis result in products that can be regulated as genetically modified organisms. As a result of the decision, new products created by using CRISPR and similar gene-editing techniques are genetically modified organisms within the scope of the European Union’s GMO Directive and are therefore subject to the stringent approval process for all genetically modified organisms.
  • In response to the decision, the German Bioeconomy Council, a panel of 17 researchers who advise the German Federal Government, has called for new EU legislation governing crops created by plant-breeding technologies, such as CRISPR. In a statement, the Council noted, “[i]n its current form, EU genetic engineering legislation cannot do justice to the opportunities and challenges of the technologies. We need an amendment to bring it in line with advances in the field. It is important to have a regulation that distinguishes between mutations and gene transfers and provides for risk-oriented approval and release procedures.” In addition to calling for legislation that is suited to the different applications of new technologies, the Council also argued that mandatory product labeling is not practical since modifications cannot always be scientifically or technically detected or proven in the end product. Scientists and industry leaders in the UK also put out an open letter calling on the UK government to provide clarity on the future of gene-edited crops following the EU ruling, particularly in the context of Brexit and the future relationship between the UK and the EU.
  • In March, the United States Department of Agriculture (USDA) Secretary Sonny Perdue announced that under its biotechnology regulations, it has no plans to regulate genome editing when used to produce new plants varieties that are indistinguishable from those developed through traditional breeding methods as long as they are not plant pests or developed using plant pests. Separately, USDA’s Agricultural Marketing Service (AMS) is working to implement the National Bioengineered Food Disclosure Standard, which will regulate the labeling of bioengineered foods in the US.

Keller and Heckman will continue to monitor developments on the domestic and foreign treatment of novel DNA techniques as well as the implementation of the National Bioengineered Food Disclosure Standard.

 

  • On August 21, 2014, USDA-FSIS published a final rule called the “Modernization of Poultry Slaughter Inspection” (79 FR 49566, Aug. 21, 2014) which amended the Agency’s poultry regulations to establish an inspection system for young chicken and turkey slaughter establishments, called the New Poultry Inspection System (NPIS). Under the final rule, the maximum line speed for young chicken slaughter establishments that operate under NPIS is 140 birds per minute.  9 C.F.R. 381.69(a). As previously covered on this blog, on September 1, 2017, the National Chicken Council (NCC) petitioned USDA-FSIS to implement a waiver system to permit young chicken slaughter establishments participating in the NPIS and the Salmonella Initiative Program to operate without the line speed limitations imposed under the NPIS.
  • On January 29, 2018, FSIS rejected NCC’s petition and explained that instead of establishing a separate line speed waiver program under the conditions requested in the petition, FSIS would make available criteria that it will use under its existing waiver procedures to consider individual waiver requests from young chicken establishments to operate at line speeds of up to 175 birds per minute. FSIS published these criteria in the February 23, 2018 Constituent Update, which include, among other items, meeting specific Salmonella performance standards requirements, establishing compliance with NPIS requirements, demonstrating a history of regulatory requirements, and a demonstration that new equipment, technologies, or procedures that allow the establishment to operate at faster line speeds will maintain or improve food safety.
  • On September 28, 2018, FSIS published additional criteria that poultry slaughter plants will have to meet in order to seek approval to run line speeds faster than the current limit of 140 birds per minute (83 FR 49048, Sept. 28, 2018). FSIS also announced that the 20 young chicken establishments already operating under line speed waivers must meet the new criteria to be eligible for the waiver. FSIS will consider factors such as whether plants are complying with good commercial practices, which requires that the poultry be slaughtered in a manner that will result in thorough bleeding.
  • As previously reported on this blog, FDA has been considering whether plant-based products may continue to be marketed using names of dairy foods like almond milk, soy yogurt, or vegan cheese.  A number of dairy products, including milk, cream, yogurt, and cheeses are the subjects of standards of identity.  Foods subject to a standard of identity must meet the regulatory definition for the food (e.g. milk is defined in part as “lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows”) and must be labeled using the standard of identity name.  Nonstandardized foods must also be labeled using the common or usual name.
  • On September 28, 2018, FDA published in the Federal Register a solicitation for public comment regarding the use of the names of dairy foods in the labeling of plant-based products.  FDA explains that even though the common or usual name for a plant-based product may include a dairy term, FDA may still act if the name is misleading.  In its solicitation, FDA notes that it can provide names for nonstandardized foods in regulations.  FDA is soliciting input on:
    • The current marketing conditions and labeling costs of plant-based products;
    • Consumer understanding, perception, purchase, and consumption of plant-based products;
    • Consumer understanding regarding the basic nature, characteristics, and properties of these plant-based products;
    • Consumer understanding of the nutritional content of plant-based products and dairy foods and the effect, if any, on consumer purchases and uses; and
    • The role of plant-based products and dairy foods in meeting the recommendations in the Dietary Guidelines.
  • FDA has provided a series of questions for each topic and is seeking comments by November 27, 2018.  Keller and Heckman will publish a client alert to provide additional details on the notice.

Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.

  • FDA Commissioner Scott Gottlieb announced on September 26, 2018 a new FDA policy on disclosing retail information for products subject to food recalls—particularly in Class I recall situations, where consumption of the food has a reasonable probability of causing serious adverse health consequences or death to humans or animals.  Historically, the agency has not released information on retailers where recalled food may have been purchased because such information potentially can reveal confidential supply chain information.
  • In conjunction with the announcement, FDA issued draft guidance detailing the circumstances under which FDA intends to publicly disclose the retail locations that may have sold or distributed a recalled human or animal food.  The guidance discusses FDA’s policy to publicize retailer information (e.g., specific retail store name and address) when recalled food is not easily identified as being the subject of a recall from its retail packaging or lack thereof (e.g., deli cheese, nuts, rawhide chews, or pet treats sold in bulk and fresh fruits and vegetables sold individually).
  • This is the second in FDA’s policy efforts to provide consumers with “actionable information” for protecting themselves from recalled FDA-regulated products.  The first was a draft guidance issued in January on the use, content, and circumstances for issuing public warnings for consumers in the event of a recall.  FDA is inviting comments on this new draft guidance for a period of 60 days.
  • A citizen petition filed on September 24, 2018 by the Information Technology & Innovation Foundation (ITIF) asked FDA to prohibit “non-GMO” food labeling claims, including the Non-GMO Project butterfly logo and label. ITIF argues in the petition that such claims mislead and deceive consumers about foods, food ingredients, and their characteristics related to health and safety. Thus, ITIF states that use of “non-GMO” claims constitute misbranding under the Federal Food, Drug, and Cosmetic Act. ITIF has requested that FDA issue a regulation to prohibit the use of the term “non-GMO” on consumer foods, and to require food manufacturers to revise labeling to omit any “non-GMO” terms, symbols, or claims.
  • The Non-GMO Project is a third-party certifying body for non-genetically modified food and products. In a statement released to FoodNavigator-USA, the Non-GMO Project dismissed the allegations made in ITIF’s citizen petition as “based on errors and misrepresentations.” They do not expect the petition to gain traction with the FDA because the petition is “factually inaccurate and fundamentally biased,” and prohibiting such claims would be likely challenged on Constitutional First Amendment grounds.
  • FDA already addresses the use of “non-GMO” and similar claims in guidance that was issued in November 2015.  Here, FDA states that such claims convey “zero or total absence unless a regulatory definition has been put in place in a specific situation.” FDA goes on to recommend that manufacturers not use such claims and suggests manufacturers use “other types of statements to indicate that a plant-derived food has not been produced using bioengineering.”
  • Pursuant to 21 CFR 10.30(e)(2), the FDA must respond to citizen petitions within 180 days of receipt, which means a response could be issued by March 2019. However, that response may not be substantive and may just indicate that FDA is further reviewing the matter.  Further, as stated above, it is unlikely the FDA will respond to ITIF’s citizen petition favorably, especially in light of the fact that many consumers are accustomed to seeing non-GMO claims on their food products.  We will continue to monitor this situation and report on any developments.
  • The same day that China and the United States imposed new tariffs on each other’s products, including food items, the Soybean Association issued a statement warning about the long-term effects of the trade war. Noting that U.S. soybean producers have spent more than 40 years and millions of dollars building the China market for soy and livestock products, the association pointed out that China has already “pursued new means to procure soybeans and other protein crops, including maximizing soybean imports from other exporting countries, particularly Brazil.”
  • The Trump administration imposed new tariffs of 10% on $200 billion worth of Chinese goods, including halibut, salmon, and fresh and frozen fruits, effective September 24. That amount will rise to 25% at the beginning of 2019. China responded with tariffs of 5 to 10% on $60 billion of U.S. products, including frozen vegetables.
  • By way of background, President Trump announced in June that the U.S. would impose a 25% tariff on $50 billion worth of Chinese imports to address China’s violation of American intellectual-property rights. China responded by imposing 25% tariffs on $34 billion worth of U.S. goods, including various agricultural items (e.g., seafood and pork varieties, soybeans, etc.). As we reported on this blog, the agriculture industry expressed concern at that time about the effects of the tariffs. A few months later in August, UDSA announced details of a $12 billion aid package for U.S. agriculture. While the agriculture industry generally appreciated the help, there was still concern about the effect of the trade dispute. The National Pork Producers Council President Jim Heimerl stated in a press release, “While we’re grateful and commend the administration for its action to help us, what pork producers really want is to export more pork, and that means ending these trade disputes soon.”
  • It doesn’t appear that the tariff dispute between the U.S. and China will be resolved anytime soon. We will continue to report on this issue and how it impacts American agriculture and the food industry.

Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about the VQIP.