FDA Issues Guidance for Industry on Model Accreditation Standards for Third-Party Certification Bodies

  • As previously covered on this blog, in November 2015, the FDA announced the implementing final rule “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” that establishes a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.  Click here for our summary of the final third-party certification rule.
  • On December 7, 2016, FDA issued final guidance for industry containing recommendations on third-party certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under the voluntary third-party certification program established under the FDA Food Safety Modernization Act (FSMA). The Agency previously issued a draft version of this guidance in July 2015.
  • Keller and Heckman attorneys regularly advise on FSMA-related compliance, including the third-party certification final rule, and stand ready to assist interested parties.

FDA Announces Posting of Adverse Event Report Data for Foods and Cosmetics

  • FDA’s CFSAN Adverse Event Reporting System (CAERS) is a post-market surveillance system that contains information on adverse event and product complaint reports submitted to FDA for foods, dietary supplements, and cosmetics. Adverse event reports come primarily from consumers and health care providers, and can include minor to major medical events, as well as complaints about off-taste or color of a product, defective packaging, and other non-medical issues.  Of the covered products, only dietary supplement manufacturers have a legal obligation to report adverse events to the Agency in the case of serious adverse events associated with the use of a dietary supplement (see 21 U.S.C. 379AA-1).
  • Today, FDA published a notice (81 FR 88244, Dec. 7, 2016) announcing the availability of data extracted from adverse event reports from January 2004 to the present involving food (including food additives, color additives, and dietary supplements) and cosmetics regulated by FDA’s CFSAN.  The Agency’s notice further indicates that it will now post on a quarterly basis data extracted from adverse event reports, including conventional foods and dietary supplements, and cosmetics, to help increase transparency and improve access to government data for consumers, health care providers, researchers and academics. FDA also plans to make available raw data files that can be downloaded in .csv format or through OpenFDA.gov as an application program interface (API).
  • Increasing public access to adverse event information certainly represents an important step in transparency for the Agency; however, it also raises issues as to whether the information will be used to benefit consumer class action plaintiff’s lawyers as they search for their next target in the food, dietary supplement or cosmetic industries.

FDA Extends Comment Period on Judicious Use of Antimicrobials in Animal Agriculture

  • As previously covered on this blog, FDA announced in September 2016 that it was “entering the next phase” of efforts to avoid increased antimicrobial resistance.  To achieve this goal, the Agency noted that it was specifically requesting comments on the establishment of appropriately targeted durations of use of antimicrobial drugs of importance to human medicine (i.e., medically important antimicrobial drugs) when they are administered in the feed or water of food-producing animals for therapeutic purposes.  Comments were initially slated to be accepted through December 13, 2016.
  • On November 29, 2016, FDA announced that it has extended the comment period and would now be accepting comments through March 13, 2017.
  • Antibiotic resistance continues to be a hot button issue in the food industry.  Interested parties who wish to contribute to the ongoing discourse and FDA’s efforts to curb the use of antibiotics in food-producing animals are encouraged to take advantage of the extended deadline to submit their comments to FDA.

CSPI Petitions USDA for Cancer-Risk Warning Labels on Meat

  • For years, researchers have debated the link between the consumption of red meat and cancer.  On October 26, 2015, the World Health Organization (WHO) took what is perhaps the most definitive and aggressive position thus far by any health organization on this hot-button issue, announcing that, based on a 22-member expert panel’s analysis of more than 800 studies, processed meat (e.g., sausages, bacon) should be classified as “carcinogenic” and red meat should be considered “probably carcinogenic.”  This conclusion was immediately questioned.
  • On December 1, 2016, the Center for Science in the Public Interest (CSPI) petitioned the USDA to mandate labels on packages of processed meat and poultry that would warn consumers that frequent consumption of those products may increase the risk of colorectal cancer.  CSPI’s petition cites as support the controversial October 2015 WHO findings which concluded that processed meat is carcinogenic to humans.
  • The meat industry has already challenged CSPI’s petition as being based on WHO’s tenuous findings and failing to account for numerous studies that find no relationships between meat and colon cancer.   Regardless of how USDA responds to this petition, it is clear that the debate will continue as to whether a link exists between the consumption of processed/red meat and cancer.

FSIS Proposes Amended Nutrition Labeling Requirements for Meat and Poultry Products

  • As previously covered on this blog, USDA’s Food Safety and Inspection Service (FSIS) recently issued a notice announcing that meat and poultry manufacturers may voluntarily use FDA guidelines on nutrition labeling while FSIS is in the process of drafting its Nutrition Facts labeling rules for meat and poultry products. Once FSIS publishes a final rule to update the Nutrition Facts label format for meat and poultry products, companies would have to comply with that final rule.
  • Yesterday, FSIS released a proposed rule to revise its nutrition labeling requirements for meat and poultry products to reflect current scientific research and dietary recommendations.  FSIS indicates that the changes parallel FDA’s recently revised nutrition labeling requirements (previously covered on this blog here).  In a nutshell, FSIS is proposing to:
    • Update the list of nutrients that are required or permitted to be declared;
    • Provide updated Daily Reference Values (DRVs) and Reference Daily Intake (RDI) values that are based on current dietary recommendations from consensus reports;
    • Amend the labeling requirements for foods represented or purported to be specifically for children under the age of 4 years and pregnant women and lactating women and establish nutrient reference values specifically for these population subgroups;
    • Revise the format and appearance of the Nutrition Facts label;
    • Amend the definition of a single-serving container;
    • Require dual-column labeling for certain containers;
    • Update and modify several reference amounts customarily consumed (RACCs or reference amounts); and
    • Consolidate the nutrition labeling regulations for meat and poultry products into a new Code of Federal Regulations (CFR) part.
  • FSIS will be accepting comments on the proposed rule for 60 days following its imminent publication in the Federal Register.  Keller and Heckman LLP is analyzing FSIS’ proposed revisions and will provide further information related to their implications for industry in the near future.

Will COOL Make a Come Back?

  • As previously covered on this blog, mandatory country of origin labeling (COOL) rules for beef products have long been the subject of controversy and challenge, culminating in a World Trade Organization (WTO) ruling that the COOL requirements violate U.S. trade obligations to Canada and Mexico and Congress repealing COOL as of December 21, 2015.
  • With a new administration taking office this January, some are hopeful that COOL might be brought back to life in a potential renegotiation of the North American Free Trade Agreement (NAFTA). The Rancher’s-Cattlemen Action Legal Fund (R-CALF), for example, has already called on the new administration  to restore and preserve U.S. ranchers’ ability to compete in the market by using mandatory country-of-origin labeling (i.e., COOL).  At the same time, members of the new administration’s Agricultural Advisory Committee have reportedly hinted that COOL stands no chance of being reinstated.
  • Considering the trade implications associated with reinstating COOL, it remains to be seen how COOL will fare going forward.

Menu Labeling Update

  • As previously covered on this blog, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act.  Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar menu items) must provide calorie and other nutrition information for standard menu items.  Although the menu labeling requirements were originally scheduled to take effect on December 1, 2015, enforcement was later delayed to December 1, 2016.  Then, due to a provision in the omnibus spending bill passed last December, enforcement was further delayed until one year after the issuance of final guidance on the menu labeling requirements.  On May 5, 2016, FDA published a notice of availability of the final guidance in the Federal Register in early May, and noted that the Agency intends to begin enforcing the menu labeling final rule one year thereafter (i.e., May 5, 2017).
  • Yesterday, FDA issued a constituent update, reiterating that FDA will not begin enforcing the final rule until May 5, 2017. Relatedly, California will be enforcing its own menu labeling regulations (identical to FDA’s) as of December 1, 2016.
  • Businesses may want to confirm whether other states or local jurisdictions are now or are about to enforce state or local requirements.  Covered entities should also be developing compliance strategies and familiarizing themselves with the final menu labeling rule and related guidance document in preparation for federal compliance by May 2017.

NARMS Report Finds Record Low Salmonella in Retail Chicken and Ground Turkey

  • The National Antimicrobial Resistance Monitoring System (NARMS), established in 1996, is a collaborative program of state and local public health departments and universities, the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture (USDA).  NARMS gathers surveillance data from human clinical samples, slaughter samples and retail meat samples and tracks changes in the antimicrobial susceptibility of enteric (intestinal) bacteria found in ill people (CDC), retail meats (FDA), and food animals (USDA) in the U.S. NARMS data are used by FDA to make regulatory decisions designed to preserve the effectiveness of antibiotics for humans and animals.
  • In a report issued this month (which covers data from calendar year 2014), NARMS found measurable decreases in salmonella present in retail chicken and ground turkey.  More specifically, for retail meat testing in 2014, NARMS found that salmonella recovery continued to decline in poultry sources to the lowest levels in 20 years of NARMS testing, reaching a prevalence of 9.1% in chicken and 5.5% in ground turkey, while remaining below 1.5% in beef (0.8%) and pork (1.3%).  This report also notes a consistent decline in the proportion of salmonella isolates from retail chicken meat that are multi-drug resistant.
  • This latest NARMS report is encouraging to food safety advocates and industry alike – both of whom are continually seeking to reduce the prevalence of foodborne illnesses while balancing considerations of curbing antimicrobial resistance.

Chipotle Calorie Gaffe

Three private plaintiffs are suing Chipotle in a Los Angeles superior court for inaccurate calorie labeling for its chorizo burrito.  The plaintiffs, who are alleging breach of warranty and violations of California’s Business and Professions Code, are seeking class action certification that would cover all people who bought food at Chipotle for the four years leading up to the filing of the complaint.

The Chipotle menu board in question states “CHORIZO BURRITO: Try our new deliciously seasoned, perfectly grilled spicy chicken and pork sausage in a burrito with white rice, black beans, fresh tomato salsa, and sprinkle of cheese.”  This text is followed by the price of the burrito and the statement “300 calories.”  However, when one uses Chipotle’s Nutrition Calculator, the burrito described on the menu board has more than 1,000 calories; Chipotle has stated that the 300 calories was intended to refer only to the chorizo component.

The Chipotle suit highlights that restaurants may face litigation risk if the calorie information on its menu boards is inaccurate.  We expect this will not be the last calorie lawsuit we hear about as the compliance date for federal menu labeling requirements approaches on May 5, 2017.  The federal requirements apply to restaurants (and similar retail food establishments) if they are part of a chain of 20 or more locations, doing business under the same name, offering for sale substantially the same menu items and offering for sale restaurant-type foods.  Only calorie information must be displayed on menus and menu boards; however, additional nutrition information must be available on request.

FDA Publishes Biennial Uniform Compliance Date for 2017-2018 Food Labeling Regulations

  • As our readership is well aware, FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact on the food industry of having to respond separately to each change.  That being said, FDA also sets specific compliance dates outside the uniform compliance date as needed.  For example, the compliance date for the Revision of the Nutrition Facts and Supplements Facts Labels, issued on May 27, 2016, is July 26, 2018, which effectively provides industry with more time than would have otherwise been permitted under a uniform compliance date.
  • Today, FDA announced that January 1, 2020 will be the uniform compliance date for food labeling regulations that are issued in calendar years 2017 and 2018.  The Agency notes that this action does not change existing requirements for compliance dates contained in final rules published before January 1, 2017.
  • All food products subject to the January 1, 2020 compliance date must comply with the appropriate regulations when initially introduced into interstate commerce on or after January 1, 2020.

The Daily Intake will return on Monday, November 28.  We extend our best wishes to those of you celebrating the upcoming Thanksgiving holiday.