United States Issues WTO Counter Notification Against India’s Market Price Support

FDA Releases Intentional Adulteration Training Course

  • In partnership with the Food Safety Preventive Controls Alliance (FSPCA), FDA has developed a free 30-minute “Food Defense Awareness for the Intentional Adulteration (IA) Rule” online training course to assist industry in complying with Food Safety Modernization Act (FSMA) requirements under the Final Rules for Mitigation Strategies to Protect Food Against Intentional Adulteration.
  • The training is the first in a series of six anticipated training materials to be released in partnership with FSPCA; the subsequent trainings will cover: (1) an overview of the IA rule, (2) IA “key activity types, (3) IA identification and explanation of mitigation strategies, (4) vulnerability assessments, and (5) food defense plan preparation and reanalysis.
  • The IA rules require covered facilities to develop and implement a food defense plan that protects the facility’s most vulnerable points from acts of intentional adulteration intended to cause wide-scale public health harm.  The newly-released training course is separate from guidance documents that FDA is developing and planning to issue in installments in advance of the July 26, 2019 compliance date for most businesses. As reflected in recent comments by Commissioner Scott Gottlieb, there is confusion among industry concerning just what the rules require from industry.

U.S. House Representatives Work with USDA to Address Food Waste

  • As previously covered on this blog, food waste is a major issue in the United States.  Government estimates indicate that Americans waste between 30 and 40% of the overall food supply on an annual basis.  According to the USDA, consumers are responsible for nearly 90 billion pounds of food waste each year, which equates to 20% of the U.S. food supply. And while perfectly good food goes to waste, approximately 40 million Americans are food insecure.
  • On April 30, 2018, Congressman David Young (R-IA) and Congresswoman Chellie Pingree (D-ME) launched a House Food Waste Caucus to explore opportunities to reduce food waste. The bipartisan Caucus will explore ways to promote food waste reduction across the food supply chain, provide educational opportunities to congressional members and staff, support efforts to reduce food waste at federal agencies including USDA and EPA, and collaborate with diverse stakeholders to highlight food waste success stories.
  • In connection to the Caucus, on May 8, 2018, USDA Secretary Sonny Perdue hosted a food waste roundtable with Reps. Pingree and Young, food industry leaders, and non-profit groups to raise awareness around food waste and to discuss solutions with leaders throughout the entire food supply chain. Secretary Perdue stated the need to “change the culture and adopt a holistic approach” to tackle food waste.
  • The House Caucus is not the first attempt by Congress to address food waste. In 2016, Rep. Pingree and Senator Richard Blumenthal (D-CT) introduced H.R. 5298 – The Food Date Labeling Act, which aimed to establish a uniform national system that distinguishes between foods bearing a label indicating peak quality from foods bearing a label that indicates a potential safety risk if they are consumed after the listed date.  The bill would also ensure that food is allowed to be sold or donated after a quality-based date. And while the bill was not enacted, the House Caucus demonstrates Congress’s continued effort to reduce food waste.

WHO Targets Saturated and Trans Fatty Acids

  • The World Health Organization (WHO) released draft guidelines on saturated fatty acid and trans-fatty acid intake for adults and children. The draft guidelines suggest that adults and children reduce their intake of saturated fatty acids to less than 10% of total energy intake and their intake of trans-fatty acids to less than 1% of total energy intake. Furthermore, the draft guidelines recommend using polyunsaturated fatty acids as a source of replacement energy, if needed. The objective of the recommendations is to reduce the risk of noncommunicable diseases (NCD’s) in adults and children.
  • The WHO first issued population nutrient intake goals for the prevention of NCD’s in 1989. (We reported on WHO’s recommendation to reduce free sugars intake to less than 5% of total daily energy intake in 2015.)  WHO Member States and all relevant stakeholders may comment on the draft guidelines between May 4 and June 1, 2018. (A call for public comments on the draft guidelines, along with directions for accessing the draft guidelines, can be found on WHO’s website.)
  • While the WHO is a respected public health body, decisions about appropriate regulatory responses to the organization’s recommendations are made by individual governments. In the U.S., the Food and Drug Administration (FDA) issued its final rules to implement changes to nutrition labeling requirements on May 20, 2016. Both sugars and fats are addressed in the new nutrition labeling requirements that are currently scheduled to take effect on January 1, 2020 for manufacturers with $10 million or more in annual foods sales and on January 1, 2021 for manufacturers with less than $10 million in annual food sales. More specifically, the final rule on Food Labeling: Revision of the Nutrition and Supplement Facts Label requires added sugars to be included on the Nutrition Facts label, which is a new requirement. The amount of saturated fat and trans fats per serving is listed on the current label and will be required on the new labels, however, listing of “calories from fat” will not be required on the new labels. The full global impact and response to the WHO’s recommendations on saturated fatty acids and trans-fatty acids remains to be seen, however.

FDA Finalizes Menu Labeling Guidance

  • As covered on this blog, the Food and Drug Administration issued draft guidance for industry on November 7, 2017 with examples and clarification on the Affordable Care Act’s requirements for menu labeling.  The compliance date for the menu labeling provisions for covered establishments, i.e., 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), is today, May 7, 2018.
  • FDA today finalized the draft guidance document, titled Menu Labeling: Supplemental Guidance for Industry, with some changes.  In a Constituent Update, FDA promises the final guidance now addresses issues that industry had complained were unclear in the draft guidance.  FDA also confirmed its intent to allow establishments a reasonable opportunity to make corrections for minor violations of the menu labeling provisions.
  • Keller and Heckman is closely analyzing the finalized Menu Labeling: Supplemental Guidance for Industry.  Interested parties who may have questions on how to comply with the menu labeling provisions may contact us at fooddrug@khlaw.com.


FDA Confirms Extension of Compliance Dates for Nutrition Labeling and Serving Size Rules; USDA Proposes National Bioengineered (BE) Food Disclosure Rules

FDA Confirms Extension of Compliance Dates for Nutrition Labeling and Serving Size Rules

USDA Proposes National Bioengineered (BE) Food Disclosure Rules

  • The United States Department of Agriculture (USDA) published in the May 4, 2018 Federal Register the long awaited proposed regulations implementing the National Bioengineered Food Disclosure Standard enacted in 2016.
  • The rule would require food manufacturers and other entities that label foods for retail sale to disclose information about BE food and BE food ingredient content.  The rule would serve as a national standard for disclosure, preempting inconsistent state laws enacted over the past several years.
  • Consistent with the law, the proposed rule defines bioengineered food as containing DNA that is modified through in vitro techniques in a way that could not otherwise be obtained through conventional breeding or which is not found in nature.  However, the proposed regulations do not address the more creative biotech approaches, thresholds or exemptions that industry was anxiously awaiting.  USDA is soliciting additional comments regarding whether highly processed foods, which may have all of their DNA removed, derived from bioengineered foods should be considered bioengineered due to the possibility that trace amounts of DNA will remain.  The comment period will close in 60 days on July 3, 2018.

Keller and Heckman is closely analyzing the proposed BE food disclosure standard.  Stay tuned for our client alert which will provide a more detailed summary.

FDA and FTC Take Enforcement Action on E-Liquids That Resemble Foods

  • FDA has joined the Federal Trade Commission (FTC) in issuing warning letters to 13 companies that market nicotine-containing e-liquids in packaging that has the appearance of being foods that appeal to children, such as juice boxes, candies, and cookies.
  • FDA and FTC took action based on the risk that consumers, especially children, may confuse the e-liquid products as foods and noted that ingesting e-liquids could result in serious harm or death.  In some letters, FDA stated that the e-liquids were sold to minors in violation of Section 903(a)(7)(B) of the Federal Food, Drug and Cosmetic Act.
  • These warning letters, along with FDA’s recently published Advanced Noticed of Proposed Rulemaking to obtain information related to the role that flavors play in tobacco products, indicate that the Agency may seek to eliminate at least some e-liquids flavors, as well as address kid-appealing marketing tactics, in order to curb the use of vapor products by youth.  For a more detailed discussion of this and other recent FDA activity concerning tobacco and vapor products, please see our related article “FDA and FTC Issue 13 Warning Letters to E-liquid Companies for Misleadingly Marketing to Youth; FDA Investigates Underage Use of JUUL Devices,” published on our companion blog, the Continuum of Risk.

Pennsylvania House Committee Passes Soda Tax Preemption Bill (subscription to Law360 required)

  • As previously covered on this blog, Philadelphia enacted a 1.5-cent-per-ounce tax on distributors of sweetened beverages (including soda and diet soda, non-100% fruit drinks; sports drinks; flavored water; energy drinks; pre-sweetened coffee or tea; and non-alcoholic beverages intended to be mixed into alcoholic drinks) as a revenue generating measure to fund local health and education needs. The tax took effect on January 1, 2017, but has faced legal challenges, most notably by the American Beverage Association (ABA) (see previous blog coverage here).
  • On May 1, 2018, a Pennsylvania legislative committee signed off on a measure that would invalidate the tax on sweetened beverages and preempt other municipalities in the state from enacting similar measures. The bill, which was approved by the Pennsylvania House Commerce Committee on a 17-9 vote, would prevent local governments from placing fees, surcharges, or taxes on food, beverages, and food and beverage containers.
  • Alex Baloga, head of the Pennsylvania Food Merchants Association, hailed the bill, saying it will “protect all Pennsylvanians from new taxes on food and beverages, including hardworking families who can’t afford more expensive grocery bills, small businesses that would lose customers and labor groups whose members could see their jobs cut.” However, this bill is just one aspect of the fight over the sweetened beverage tax. Currently, the Pennsylvania Supreme Court is weighing whether the tax is an improper duplication of the state’s sales tax. And Pennsylvania Governor Tom Wolf has already vetoed one bill passed by the General Assembly that would prevent municipalities from enacting taxes on food and beverage containers, like plastic bags.
  • Sweetened beverage taxes are relatively new initiatives, with Berkeley, California passing the first beverage tax in November 2014. And although it is well established that excess sugar consumption is inadvisable, it remains to be seen whether such taxes will be able to strike a balance between public health and consumer choice.

Missouri Considers Plant-Based Meat Labeling Bill

  • The Missouri House approved a bill that would ban companies from labeling lab-grown meat products or meat substitutes as meat (St. Louis Post Dispatch). The labeling proposal is included in House Committee Bill 16, which passed the House by a vote of 107 to 38 on April 26, 2018. Now before the state Senate, the legislation has a May 18 deadline to reach the governor’s desk to be signed. The bill is supported by the Missouri Farm Bureau, the Missouri Cattlemen’s Association, and the state’s pork producers, while companies that produce plant-based, meat-like products oppose the legislation.
  • If this bill is signed into law, Missouri would be the first state to address this issue. However, on the national level, as previously reported on this blog, the United States Cattlemen’s Association  filed a petition with the USDA’s Food Safety and Inspection Service (FSIS) requesting that the Agency undertake rulemaking on beef labeling to clarify for consumers the difference between beef derived from cattle and “beef” products created in a laboratory.
  • The popularity of plant-based meats is increasing. For example, we reported in September 2017, that retail sales of plant-based foods intended to replace animal products rose by 8.1 percent over the previous year, topping $3.1 billion in sales. As this trend continues, we expect to see more regulatory activity in this area and will continue to report on future developments.

FDA May Formally Request Information on Using “Milk” in the Names of Plant-Based Products


  • As previously reported on this blog, opposing sides have urged the Food and Drug Administration (FDA) to weigh in on the use of the term “milk” in labeling plant-based products, such as “soy milk” and “almond milk.”
  • The dairy industry asserts that plant-based products labeled using milk or other dairy-related terms violate FDA’s standard of identity regulations, and has urged FDA to take action.  In January 2017, Senator Tammy Baldwin (D-WI) introduced a bill, the Dairy Pride Act, which would have amended the Federal Food, Drug, and Cosmetic Act to prohibit the sale of any food that uses the market name of a dairy product, and is not the milk (i.e., lacteal secretion) of a hooved animal, is not derived from such milk, or does not contain such milk as a primary ingredient.
  • On the other side of the debate, the Good Food Institute (GFI) petitioned FDA in March 2017 for a regulation to clarify that “new foods may be named by reference to other ‘traditional’ foods in a manner that makes clear to consumers their distinct origins or properties.”  GFI’s request states that a significant and growing group of consumers has sought to reduce or eliminate dairy products from their diet and that plant-based alternatives to traditional dairy products are becoming more common.  FDA responded within the 180-day timeframe (required by law), but only to indicate no action was being taken at the time and suggesting the issue was not a high priority for future activity.
  • Last week, however, there was some indication that FDA may finally prioritize the issue.  Addressing questions from Senator Baldwin at an April 25, 2018 Senate Appropriations Committee Hearing, FDA Commissioner Gottlieb promised forthcoming FDA activity, but not imminent enforcement against “almond milk” or other such products.  Specifically, Dr. Gottlieb indicated that with industries’ reliance on FDA’s “regulatory discretion” on use of the term “milk” on plant-based products, data on consumer understanding are necessary before FDA could act.  In this regard, the commissioner indicated that FDA will issue a request for information on consumer understanding of the terms at issue and any potential confusion over nutritional equivalency.  While this process is not likely to be completed quickly, it may eventually bring some greater certainty to the labeling of these types of products.



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