• Four democratic senators wrote President Donald J. Trump on February 13, the same day that the General Accounting Office (GAO) released a report on federal oversight of food safety, asking that the Administration work with Congress to implement the recommendations in the report. The report is titled, Food Safety A National Strategy Is Needed to Address Fragmentation in Federal Oversight, and is dated January 2017.
  • The GAO report states that while FDA and FSIS have taken actions since 2014 to address fragmentation in the federal food safety oversight system, more needs to be done. GAO calls for a national strategy to identify short- and long-term actions to improve the food safety oversight system.
  • The four senators—Kristen Gillibrand (D-NY), Richard J. Durbin (D-IL), Dianne Feinstein (D-CA), and Richard Blumenthal (D-CT)—requested that efforts begin immediately to establish the recommended national strategy to address the shortcomings in food safety oversight. The letter also asks the Administration “to work with Congress to request any additional statutory authority or budgetary consideration that is required in order to enhance the implementation of the government performance plan.”
  • The senators concluded by stating that if the Administration does not feel that their recommendations are justified, they would like “detailed responses from the appropriate agency and department authorities as to why the current food safety system is considered adequate to address the Nation’s food safety needs.”
  • Concern about fragmentation within the federal food safety system is not new. However, obtaining more funding to develop a national strategy on food safety under the current Administration might be problematic, given its emphasis on reducing regulatory costs.

CFSAN to issue electronic export certificates for food products.

  • Upon request by an exporter, FDA issues certificates of free sale (COFS) for certain food products regulated by FDA’s Center for Food Safety and Applied Nutrition (CFSAN). Although FDA does not require export certificates to export foods to foreign countries, review of a certificate may be required by foreign countries as part of the process to import a product into those countries.
  • Starting February 20, 2017, COFS will be issued online as downloadable Portable Document Format (PDF) files. Exporters will continue to use the FDA Certificate Application Process (CAP) to request COFS (account with FDA Industry Systems required). CFSAN is also revising the appearance of the COFS, including an updated letterhead and image of the Health and Human Services (HHS) seal. Additionally, for each certificate, FDA will provide a unique Certificate Identifier, which will allow foreign government officials authorized by the FDA to verify the authenticity of the certificate.
  • The change from paper to PDF certificates is expected to make the process of issuing COFS more efficient for both exporters and CFSAN. In addition to allowing exporters to submit applications and receive certificates electronically, CAP also allows exporters to receive real-time status updates via email and online tracking and to copy, edit, and resubmit applications.

Today, FDA announced a public meeting to give interested persons an opportunity to discuss the use of the term “healthy” in the labeling of human food.

  • As previously covered on this blog,  on September 28, 2016, FDA published a request for comment in the Federal Register.  The comment period, which was originally scheduled to end on January 26, 2017, was later extended to April 26, 2017.  At the same time, FDA published a guidance for industry entitled “Use of the Term ‘Healthy’ in the Labeling of Human Food Products,” in which the Agency stated their intent to exercise enforcement discretion with respect to the implied nutrient content claim “healthy” on foods that have a fat profile of predominantly mono and polyunsaturated fats, but do not meet the regulatory definition of “low fat,” or that contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D. FDA has received over 800 comments in response to its request, and on January 27, 2017, FDA received a Citizen Petition from the Union of Concerned Scientists urging the FDA to establish “disqualifying levels” of added sugars that would render a product ineligible to use labeling or advertising with “healthy” claims.
  • FDA could promulgate regulations to formalize its current enforcement strategy as is or with amendments, including, potentially, establishing a “disqualifying level” for added sugars as part of its possible redefinition of the term “healthy”. The public meeting, which will be held in Rockville, Maryland on March 9, 2017, will offer an opportunity for interested parties to weigh in on these issues and others relating to the use of the term “healthy” in the labeling of human food.
  • The meeting will include introductory presentations, perspectives panels, and multiple opportunities for individuals to express their opinions at the meeting through oral presentations, participation in breakout sessions, and submission of electronic or written comments. FDA remains particularly interested in information, experiences, and issues related to:
    • “healthy” as a nutrient-based claim, food component-based claim, or both;
    • “healthy” single definition or definition by category;
    • consumer understanding of and response to the term “healthy”; and
    • when, if ever, the use of the term “healthy” may be false or misleading.
  • K&H will continue to closely monitor developments in this area. Clients who are interested in submitting written comments or in receiving a summary of the public meeting are invited to contact Melvin Drozen at drozen@khlaw.com or 202-434-4222.
  • A 1.5 cent per ounce tax on sugar-sweetened beverages sold in Philadelphia took effect on January 1 of this year. As reported on this blog, the American Beverage Association (ABA) together with retailers, distributors and consumers filed a lawsuit in September 2016 challenging Philadelphia’s soda tax. Philadelphia Court of Common Pleas Judge Gary S. Glazer ruled in favor of the tax, but the beverage industry is appealing that decision.
  • A coalition of 5 state senators and 31 state representatives filed an amicus brief last week in the Commonwealth Court of Pennsylvania opposing Philadelphia’s beverage tax. The legislators argue that the sweetened beverage tax is unlawful since the products it covers are already subject to the state’s sales tax. Noting that the Appellee had argued that the tax is allowed because it is imposed on “the distribution” of the product and not at the sales point, the legislators provided examples of how the beverage was being passed on to consumers and also noted that the tax is not applied equally to all beverages.  Some of examples provided are listed below.
    • A Coca-Cola six-pack is taxed at 57% at the Collins Shop Rite.
    • A 15-pack Gatorade is taxed at 42%, a 12-pack of Ginger Ale is taxed at 21%, Waist Watcher Diet Tonic Water is taxed at 78 %, and a 4-pack of Red Bull is taxed at 6% at a Fresh Grocer.
  • Another argument against Philadelphia’s beverage tax is it will result in lost revenue in state tax. Explaining, the brief states, “Allowing this tax to remain not only causes immediate lost revenue to the general fund but will then snowball to make a budget every year become even more of a problem…. It is not unrealistic to expect that next year there will be a “candy tax” based upon volume in Philadelphia, a sweetened beverage tax based upon volume in Harrisburg, and a “snack/cookie tax” based upon volume in another cash-strapped city.”
  • The outcome of the appeal could impact efforts by other jurisdictions to bridge budget gaps with similar taxes. See our blog entry, Five More U.S. Cities to Tax Soft Drinks.
  • Fluorinated chemicals are used in formulating food packaging paper and paperboard materials for their grease-repellent properties.
  • A recent study by the Silent Spring Institute, published in Environmental Science & Technology Letters, suggests that a substantial portion of the paper and paperboard used for fast food packaging contains certain fluorinated grease-proofing chemicals, including poly or perfluoroalkyl substances (PFAS).  The study, which has received extensive media attention (see e.g., here and here), implicitly suggests that the presence of PFAS in the food packaging poses some safety or environmental concern.
  • While the press coverage suggests a potential health concern for consumers based on this study, at least some of the news articles do reference a U.S. Food and Drug Administration (FDA) spokesperson who stated that FDA has carefully reviewed the science on short-chain compounds and has not identified any safety concerns.
  • Additional coverage of the study and its implications is available on Keller and Heckman’s Packaging Law website.  For further information on the regulatory challenges facing the paper packaging industry both in the U.S. and abroad, sign up to attend Keller and Heckman’s 2nd Annual Paper Packaging Law Seminar, to be held April 4-5, 2017 in Atlanta, Georgia.
  • While much attention in the area of genetically modified organism (GMO) legislation has previously focused on labeling laws such as Vermont’s labeling law and, more recently, the federal GMO bill signed into law on July 29, 2016, various local jurisdictions have considered or enacted local bans on the cultivation of genetically modified (GM) crops.
  • Earlier this month, legislation was introduced in the Oregon state legislature that would repeal parts of a 2013 Oregon law that preempts local county laws or rules from regulating farm practices, including restrictions on the cultivation of GM crops.  In other words, if the proposed legislation becomes law, various local county governments would be authorized to implement local legislation banning the cultivation of GM crops.  For example, the passage of this bill would revive a GMO ban approved in May 2014 in Josephine County, Oregon.
  • The introduction of this legislation highlights the continued conflicts and tensions surrounding the cultivation of GM foods in the U.S.  The success of this latest effort to ban GMO cultivation at the local level remains to be seen.
  • As previously covered on this blog, on January 19, 2017, USDA published a proposed rule to update its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms in response to advances in genetic engineering and the Agency’s understanding of the plant pest and noxious weed risk posed by genetically engineered organisms.  The proposed updates would represent the first comprehensive revision of the regulations since they were established in 1987.
  • Today, APHIS announced that it would be extending the comment period for the proposed rule to June 19, 2017.  82 FR 10312.
  • With a new administration at the helm, it remains unclear whether this proposed rule will move forward following the end of the comment period on June 19, 2017.  Industry stakeholders are encouraged to take advantage of this additional time to prepare and submit comments to the Agency to ensure that any future Agency action as it relates to the proposed rule will result in the least regulatory burden possible.
  • As previously covered on this blog, on January 19, 2017, USDA published a controversial final rule on organic livestock and poultry which establishes minimum indoor and outdoor space requirements for chickens as a function of type of production and stage of life. 82 FR 7042.
  • On February 9, 2017, USDA published a Notice in the Federal Register delaying the effective date of the Organic Livestock and Poultry Practices final rule by 60 days to May 19, 2017.  The Agency noted that this delay is consistent with the Memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled, “Regulatory Freeze Pending Review.”
  • Given the controversial nature of the final rule and a new administration at the helm, the ultimate fate of this rule continues to remain unclear.
  • The American Heart Association (AHA) is a non-profit organization in the U.S. that seeks to reduce disability and deaths caused by cardiovascular disease and stroke.  One way AHA seeks to achieve this goal is through its Heart-Check food certification program.  Under this program, AHA reviews foods to determine compliance with specific nutrition requirements.  Foods with AHA’s “Heart-Check” affixed thereto are considered “heart-healthy”.  The list of “heart-healthy” products is maintained at www.heartcheck.org.
  • On February 6, 2017, the National Pork Board announced that the AHA has designated pork sirloin roast as a “heart-healthy” food.
  • The National Pork Board will be working with the AHA in the coming months to spotlight the “heart-healthy” benefits of pork sirloin roast. Food marketers interested in affixing the “Heart-Check” to their pork sirloin roast must, of course, ensure that their product labeling is fully compliant with USDA-FSIS regulations.
  • The potential impact on FDA of several executive orders issued within weeks of President Donald Trump taking office has raised concerns.
    • A January 20, 2017 memorandum from White House Chief of Staff Reince Priebus to the heads of executive departments and agencies titled, “Regulatory Freeze Pending Review,” states that new regulations must be reviewed by someone appointed or designated by the President and that regulations that have been published in the Federal Register but that have not taken effect  must be postponed 60 days from the date of the Freeze Memo, unless subject to statutory or judicial deadlines. The memorandum also directed Agency heads to immediately withdraw from the Office of the Federal Register (OFR) any regulations that have been submitted to OFR but not yet published in the Federal Register. On January 24, the White House issued a memorandum on implementation of the regulatory freeze.
    • On January 23, 2017, President Trump issued a memorandum ordering a freeze on the hiring of federal civilian employees. OMB and OPM issued a guidance document on January 31, 2017 that clarified some of the details of the federal hiring freeze.
    • On January 30, 2017, the White House issued an Executive Order on reducing regulation and controlling regulatory costs, which directed federal agencies to eliminate two regulations for every new one they propose. The order imposed a zero cost of all new regulations for fiscal year 2017. On February 2, the White House issued an Interim Guidance on implementing the Executive Order on reducing regulation and controlling regulatory costs.
  • The Alliance for a Stronger FDA responded to these executive orders by pointing out that less money, fewer people, and fewer regulatory communications (in an agency that promotes and protects the public health through regulation and guidance) feels threatening to FDA’s mission. “In light of this, the Alliance and its members are going to need to step up and engage in an unprecedented education campaign on how the FDA works, and why strengthening the agency is actually going to achieve the President’s objectives of a more prosperous and safer America,” stated the Alliance in a February 3 release. Concerning the federal hiring freeze, the Alliance was encouraged by the guidance issued on January 31, since it mentioned that safe food and drugs were within exempt categories. However, in a statement titled, “Advocacy at a Glance,” the Alliance pointed out that it is still unclear whether FDA can interpret the exemption broadly or narrowly.
  • With respect to the executive order on controlling regulatory costs, the Consumer Federation of America issued a press release, titled, “Executive Order Fails to Consider Benefits of Food Safety Regulation.” The press release stated, in part, “This order is likely to compromise Americans’ food safety and increase the risk of widespread outbreaks of foodborne illness by hampering the work of the Food Safety and Inspection Service at USDA and the Food and Drug Administration.”
  • The Center for Science in the Public Interest (CSPI) also reacted on the executive order on controlling regulatory costs, saying that it threatens public health. (Click here to see CSPI’s statement on the order.)
  • The full impact of these orders on FDA and USDA is not yet known so stay tuned for more information concerning the regulation of foods under the new administration.