• As previously reported on this blog, in August 2013, the U.S. Food and Drug Administration (FDA) issued a final rule on “gluten-free” food labeling. After the final compliance date of August 5, 2014, FDA measured the gluten level of more than 250 different products labeled “gluten-free.”
  • More than 99.5% of the food products labeled “gluten-free” that FDA tested were in compliance with the requirement that such foods have less than 20 ppm (parts per million) of gluten. In total, FDA collected and analyzed 702 samples from more than 250 products labeled “gluten free.” The products were collected between July 2015 to August 2016.
  • Only five samples from one of the products labeled “gluten-free” did not comply with the less than 20 ppm requirement. That product was recalled and subsequent sampling by FDA did not find levels of gluten that violated the regulation.
  • Products tested were from three commodity groups: cereals, grain bars and flours. Results of the surveillance sampling can be accessed from FDA’s website.
  • As previously covered on this blog, the general compliance date for the foreign supplier verification program (FSVP), under the Food Safety Modernization Act (FSMA), is May 30, 2017 (for a summary of which importers are covered by the general compliance date, see here). The U.S. Food and Drug Administration recently issued additional guidance for importers on FSVP compliance.
  • In the new guidance, issued in a question and answer format, FDA noted that the Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system will now require filers to provide an “entity role code” to indicate whether the importer is subject to the May 30 compliance date. If so, the entity should enter “FSV,” which will prompt the ACE system to ask for the importer’s name, email address, and unique facility identifier.  If the food is exempt from FSVP because it will be used for research or evaluation in accordance with 21 CFR 1.501(c), the filer should enter code “RNE”; if the food is exempt from FSVP for any other reason, or if compliance with FSVP is not yet required, the filer should enter code “FSX.”
  • FDA indicated that it will focus on education, training, and technical assistance as regulated entities work to understand and comply with the new regulations.  The Agency stated that, at this time, its priority is to support compliance, but cautioned that “when appropriate, the agency will act swiftly” in response to “problems that pose a danger to health or reflect intentional disregard for legal responsibilities.”
  • We will continue to monitor and report on FDA’s activities to implement the FSVP rule and other FSMA related activities. Please feel free to contact us at fooddrug@khlaw.com with any questions.
  • USA Rice, in a recent blog post indicated that it is considering asking FDA and other regulatory agencies to “look into” the use of “rice” or “riced” in the name of vegetables that have gone through a ricer.  USA Rice President and CEO Betsy Ward states “Vegetables that have gone through a ricer are still vegetables, just in a different form.  Only rice is rice, and calling ‘riced vegetables,’ ‘rice,’ is misleading to consumers.”
  • As previously covered on this blog, members of the United States House of Representatives sent FDA a letter requesting that FDA enforce the standard of identity for milk, especially as it pertains to the use of the name “milk” for plant-based products (including soy, rice, and various tree nuts).
  • FDA has previously stated that food products that are similar to foods for which a standard exists (e.g. butter created using a cultured cream) can name their product a modified version of the food name (e.g. cultured butter).
  • USA Rice’s stance on riced vegetables, following on pressure on FDA to consider whether non-dairy milk violates the milk standard, seems to indicate a general trend of protecting the use of food names against purported imitators.
  • The U.S. Supreme Court declined to review the case of two executives from Quality Egg who were sentenced to prison under the Park Doctrine, also known as the Responsible Corporate Officer Doctrine, after a 2010 salmonellosis outbreak which may have sickened as many as 56,000 consumers.  Austin “Jack” DeCoster, the principal operator, and his son, Peter DeCoster, the chief operating officer, were sentenced to three months in prison and were fined $100,000 each after pleading guilty to misdemeanor criminal liability charges (one count of introducing adulterated food into interstate commerce — shell eggs contaminated with Salmonella enteriditis).  The sentences were affirmed by the 8th Circuit Court of Appeals. The DeCosters sought Supreme Court review of the constitutionality of the prison sentences in January, alleging that the strict criminal liability standard (no proof of criminal intent) resulted in a denial of due process. (For more detailed background information on the case, click here.)
  • At trial, Quality Egg pleaded guilty to a count of bribery of a public official, a count of introducing a misbranded food into interstate commerce with intent to defraud, and a count of introducing adulterated food into interstate commerce, and was fined $6.79 million.  The DeCosters’ guilty plea included a stipulation that nothing in the record indicated they had actual knowledge the eggs were infected with Salmonella. At the sentencing phase of the trial, however, the district court was entitled to consider information regarding the background, character, and conduct of the defendants, and concluded that the DeCosters had created a work environment “where employees not only felt comfortable disregarding regulations…but may have felt pressure to do so.”
  • It is not clear to what extent the DeCoster outcome will be relevant to future Park Doctrine cases, given that information before the trial court concerning past conduct, including FDA inspection findings of widespread insanitary conditions, appeared to be an important factor in the decision to impose prison sentences.   Thus, evidence of a strong company culture of regulatory compliance, with responsible corporate oversight, could distinguish the DeCoster case from future situations.
  • As previously covered on this blog, Brazilian federal police raided several meat producers earlier this year for allegedly doling out bribes to inspectors to certify meat that was either rotten or tainted with Salmonella.  Following the bribery scandal, USDA’s Food Safety and Inspection Service (FSIS) instituted 100% point-of-entry re-inspection of all Brazilian meat products imported into the United States.
  • On May 12, 2017, FSIS issued Directive 26-17 that expands the scope of pathogen testing for Brazilian raw beef product (which for the purposes of the notice also includes veal).  In particular, Directive 26-17 provides that the increased “Level of Reinspection” at the U.S. border includes conducting product examination on 100% of the lots, condition of container examination of 100% of thermally processed products, and 100% testing of ready-to-eat products for Salmonella and Listeria monocytogenes.  The ramped up inspection also includes testing 100% of beef trimmings from Brazil for Salmonella, Escherichia coli (E. coli) O157:H7, and non-O157 Shiga toxin-producing E. coli (STEC).
  • In light of lingering concerns stemming from the recent bribery scandal, FSIS’ ramped up inspection will likely continue until the Agency is satisfied that Brazil’s raw and processed beef (and veal) inspection systems are adequately addressing pathogens.
  • FDA has premarket review authority over food additives; however, substances that are generally recognized as safe (GRAS) are not legally considered “food additives” as that term is defined under the Federal Food, Drug and Cosmetic Act, and therefore are not subject to the premarket clearance requirements that apply to other substances used in or in contact with food.   Until August 2016, FDA operated a voluntary GRAS Notification Program provided for under a 1997 proposed rule.  On August 12, 2016, FDA released a final rule formalizing its GRAS Notification program and detailing the criteria for concluding that the use of a substance in human or animal food is “generally recognized as safe” (GRAS).  See previous blog coverage here.  In addition, companies also have the option to self-determine that a substance is GRAS without notifying the FDA of its conclusion.
  • Yesterday, a group of NGOs sued FDA challenging the legality of the final GRAS rule.  The lawsuit – filed by the Center for Food Safety, Breast Cancer Prevention Partners, Center for Science in the Public Interest, Environmental Defense Fund, and the Environmental Working Group – recites many of the prior concerns voiced by the NGO community with respect to substances that companies self-determine are GRAS.  In particular, the lawsuit alleges that FDA is required to review the safety of a substance before it can be used in or in contact with food, and that the Agency has therefore failed to meet its duty by not reviewing the safety of substances that companies self-determine are GRAS, noting that some self-determined GRAS substances should be considered “food additives-in-fact” and on that basis are subject to premarket review under the food additive regulatory framework.  The NGOs request that the Court:
    • (1) declare the final GRAS regulation to be unlawful and
    • (2) vacate the final GRAS regulation so that it can be re-promulgated by FDA in accordance with the NGOs’ views.
  • We will keep a close eye on developments in this case as they unfold and report them to you here.
  • In recent years, the food industry has experienced a growing demand for plant-based protein and dairy products so much so that late last year, Tyson Foods  –  one of the world’s largest meat producers – purchased a stake in a Silicon Valley startup that makes plant-based beef and chicken primarily from pea protein.  Plant-based dairy production is also on the rise.  Earlier this year, Daiya – a plant-based dairy foods company marketing dairy-, gluten- and soy-free – was recently ranked as the #1 fastest growing plant-based food company.
  • Earlier this month, The NPD Group (a leading global information company) announced findings that the market for plant-based alternatives to dairy products is gaining steam, though it remains a niche area.  In particular, NPD reports that the consumption of plant-based dairy alternatives has grown to 21 annual eatings per capita in 2016, up from 19 in 2013.  Nevertheless, the report also found that the consumption of plant-based alternatives continues to pale in comparison to dairy and meat consumption.  NPD concludes that the market for plant-based alternatives continues to evolve as consumers increasingly turn to these products because of food allergies or because they are seeking “clean” label, ethically-minded foods.
  • In light of evolving consumer tastes and trends, the market for plant-based foods appears to be ripe for continued expansion.
  • Under a standard of identity “milk” is defined as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more health cows” (21 C.F.R. Section 131.110).  For years, the dairy industry has called on the FDA to crack down on the use of dairy-related terms such as “milk” for plant-based products.  So far, FDA has not taken a position on this issue.
  • On May 17, 2017, state milk regulators voted unanimously in favor of a resolution intended to clarify the responsibilities of FDA and state programs in ensuring the proper use of standardized dairy product names.  The vote took place at the biennial meeting of the National Conference on Interstate Milk Shipments (NCIMS).  The resolution includes the statement: “Imitation products using the names of federally standardized Grade “A” milk and milk products in their product labeling have the potential to foster consumer confusion about the relationship of these products to the Grade ”A” program.”  The National Milk Producers Federation (NMPF) hailed this development as “the strongest statement yet that the abuse of dairy terms has gone too far.”  The vote was dismissed as unhelpful by the Plant Based Foods Association.
  • It remains to be seen whether FDA will take any action in response to the NCIMS resolution.
  • As background, Section 3208 of the Agricultural Act of 2014, Pub. L. 113-70 (7 USC §6935) required the Secretary of Agriculture to propose a reorganization of international trade functions for imports and exports, including a plan for the establishment of the Under Secretary for Trade and Foreign Agricultural Affairs (U/Sec TFAA).
  • On May 11, 2017, newly minted USDA Secretary Sonny Perdue announced the establishment of an Undersecretary for Trade and Foreign Agricultural Affairs as part of a reorganization of USDA.  As part of the reorganization, the Foreign Agricultural Service will be situated under the new Undersecretary for Trade, and the Undersecretary for Trade will work alongside the U.S. Trade Representative (USTR) and Secretary of Commerce Wilbur Ross.  The creation of this new post has been well-received by industry.  The National Cattlemen’s Beef Association, for example, released a statement noting that “establishing this new Undersecretary for Trade position was one of [their] top priorities for 2017” and that the position “will play a vital role in leading USDA’s efforts to capitalize on foreign demand for U.S. agriculture products.”  The National Turkey Federation and National Pork Producers Council also released congratulatory statements.
  • It remains to be seen the extent to which the creation of this new post will further advance trade policies that will benefit American agriculture.
  • As previously covered on this blog, late last week, the White House announced that China would resume beef imports no later than July 16, 2017 as part of a broader trade agreement with China.  In return, the U.S. pledged that it will remove obstacles to importing cooked Chinese poultry meat.
  • In response, Food & Water Watch issued a statement expressing concern that imports of cooked poultry from China could put American consumers at risk due to a “history of food safety problems.”
  • The precise timing of when the U.S. may begin importing cooked Chinese poultry is not yet clear as FSIS still must take a number of regulatory steps, including issuing a proposed rule in the Federal Register (currently slated for July 16, 2017) along with a comment period, prior to making a final determination as to whether China is equivalent and thus eligible to export poultry to the U.S. that was slaughtered and cooked in Chinese establishments.  As permitting poultry imports from China would potentially go a long way towards reopening the lucrative Chinese market for U.S. poultry (which has been banned from China since January 2015), we gather that every effort will be made to expedite this process.