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On March 7, the US Food and Drug Administration (FDA) announced the availability of revised guidance for industry titled “A Dietary Supplement Labeling Guide: Chapter II. Identity Statement” (Revised Guidance).1 The Revised Guidance provides clarification on whether the term “dietary supplement” may be used as the entire statement of identity for a product without other identifying or descriptive terms. Comments can be submitted to Docket 2004D-0487 on the draft Revised Guidance at any time.

The Revised Guidance comes as a result of an inaccurate statement in the 2005 guidance for the industry titled “A Dietary Supplement Guide.”2 The inaccurate statement pertained to the negative response to a question as to whether or not the term “dietary supplement,” by itself, could be considered a statement of identity. The negative response ran directly contrary to sections 201(ff)(2)(C) and 403(s)(2)(B) of the Food, Drug, and Cosmetic Act (FD&C Act) as well as 21 C.F.R. 101.3(g), which explicitly requires dietary supplements to be identified by the term “dietary supplement” as a part of the statement of identity, with only some flexibility.

On February 26, two cheese companies and one of their corporate officers, Michelle Myrter, pleaded guilty in federal court for selling “real parmesan and romano cheese” that contained high amounts of cellulose and other improper fillers. The companies, Universal Cheese & Drying Inc. and International Packing LLC, each pleaded guilty in federal court to one count of conspiring to introduce misbranded and adulterated cheese products into interstate commerce and to commit money laundering. Each company also forfeited to the United States $500,000.1 Myrter pleaded guilty as a responsible corporate officer to one misdemeanor count of aiding and abetting. She faces up to one year in prison and/or a $100,000 fine.

The recipe for parmesan and romano cheeses are standardized (also called a product’s “standard of identity”) and regulated by the US Food and Drug Administration (FDA). The investigation into the two cheese companies was instigated after a fired plant manager tipped off the FDA that the companies’ cheeses contained improper fillers. The US Department of Justice (DOJ) alleged that Myrter and the companies knew that the cheese they sold did not meet the standards of identity for parmesan and romano cheese, but they nevertheless marked the products as real parmesan and romano cheese. Notably, the DOJ acknowledged that the adulterated products never posed a threat to the health or safety of consumers.

On February 23, the US Food and Drug Administration (FDA) issued a guidance document titled Guidance for Industry: Nutrient Content Claims; Alpha-Linolenic Acid (ALA), Eicosapentaenoic Acid (EPA), and Docosahexaenoic Acid (DHA) Omega-3 Fatty Acids; Small Entity Compliance Guide1 (Guidance). The Guidance was issued pursuant to the Final Rule regarding omega-3 nutrient content claims issued in 2014, which took effect on January 1, 2016.2 Thus, this Guidance was issued after the compliance date. The Final Rule was issued in response to three notifications from seafood and fish oil producers that wished to make nutrient content claims for ALA, DHA, and EPA on their product labels. Specifically, two of the producers manufactured fish oil–based dietary supplements.

The Guidance clarifies food producers’ responsibilities with regard to ALA, EPA, and DHA nutrient content claims and prohibits certain claims. The prohibition on certain claims has wide implications for foods that previously made DHA, EPA, and certain ALA claims. Possible products affected include seafood, eggs, pasta, dairy products, juices, baby food, cooking oil, certain meats, and fat-based spreads.

Nutrient Content Claims Generally
Nutrient content claims are labeling claims that characterize the level of a nutrient in a food. The Food, Drug, and Cosmetic Act (FD&C Act) requires that companies notify FDA of a nutrient content claim at least 120 days before a food that bears the claim is introduced into interstate commerce. Among other requirements, nutrient content claims must 1) be based on an authoritative statement that identifies a nutrient level to which the claims refer and 2) be stated in a manner in which the public can understand the relative significance of the nutrient in the context of daily diet. In the Final Rule, FDA prohibited the claims set forth in the notifications for DHA and EPA and some ALA claims because they did not meet these requirements.

On January 29, the US Food and Drug Administration (FDA or the Agency) issued Import Alert 99-40: Genetically Engineered (GE) Salmon, which bans the import of any human or animal food containing GE salmon until the FDA publishes final labeling guidelines for informing consumers of such content.1

The import alert was issued to comply with language introduced in the Consolidated and Further Continuing Appropriations Act by Senator Lisa Murkowski (R-AK), an act signed into law by President Barack Obama in December 2015. The bill ordered the FDA to block imports of GE salmon until the FDA issued final guidance requiring food derived from GE salmon to be labeled as such. Currently, Alaska is the only state that requires labeling of genetically modified fish.

The mandate in the omnibus bill states, “[d]uring FY16 the FDA shall not allow the introduction or delivery for introduction into interstate commerce of any food that contains genetically engineered salmon until FDA publishes final labeling guidelines for informing consumers of such content.” The law also requires the FDA to allocate at least $150,000 of its funding to developing and implementing guidance to disclose to consumers whether salmon is genetically engineered.

On November 12, 2015, the Food and Drug Administration (FDA) announced the establishment of a docket (Docket No. FDA–2014–N–1207) to receive information and comments on the use of the term “natural” in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering.1 In direct response to subsequent requests from the public, FDA extended the closing date for the relevant original comment period from February 10, 2016 to May 10, 2016.2

To date, FDA has not developed an official definition for the term “natural,” although it has made public statements indicating the uses of the term that it accepts. For example, in a proposed rule published in 1991, FDA stated that the word ‘‘natural’’ was often used to describe a food that is composed only of substances that are not manmade and is, therefore, somehow more wholesome. In the same proposed rule, FDA stated that their informal policy considered “natural” to mean that nothing artificial or synthetic is included in, or has been added to, a product that a consumer would not normally expect. However, as a result of unclear direction from public comments, in the final rule published in 1993, FDA stated that it would not define the term “natural” but would instead maintain its policy of interpreting the term as meaning that “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.”

The National Oceanic and Atmospheric Administration (NOAA) published a final rule on January 13 that implements the Fishery Management Plan for Regulating Offshore Marine Aquaculture in the Gulf of Mexico (Gulf Aquaculture Plan). The plan allows for the first time the commercial farming and harvesting of seafood fish in federal waters off the Gulf of Mexico.1 It is intended to encourage commercial farming and harvesting of seafood in federal waters and has the potential to significantly expand US seafood production and trade. The Gulf Aquaculture Plan took effect on September 3, 2009, and this final rule implementing it will take effect on February 12, 2016.

Aquaculture or aquafarming is the practice of raising marine species in controlled environments rather than harvesting them in the wild. According to NOAA, US aquaculture production yields approximately $1.3 billion annually, which is several times less than the $5 billion annual production of wild-capture fisheries.2 Nevertheless, global aquaculture supplies half of the world’s seafood, and the aquaculture industry is expected to increase significantly in the next decade.3

Currently, there are no commercial aquaculture operations in US federal waters, which begin three to nine nautical miles off the state coasts and extend offshore for 200 miles, although there are such operations in state waters. Prior to the Gulf Aquaculture Plan, an exempted fishing permit was required to conduct aquaculture in federal waters, and the permit was valid for only one year. NOAA concluded that the limited permit duration was not a viable option for many commercial aquaculture operations.

Updated nutritional guidelines emphasize holistic eating patterns over the course of a lifespan.

On January 7, the US Department of Health and Human Services (HHS) and the Department of Agriculture (USDA) jointly issued the 2015-2020 Dietary Guidelines for Americans (Guidelines),[1]

The Guidelines are based largely on the recommendations from the Dietary Guidelines Advisory Committee (Advisory Committee), which is comprised of expert researchers in the fields of nutrition, health, and medicine.[2] The HHS and USDA stated that the updated Guidelines are intended to “reduce obesity and prevent chronic diseases like Type 2 diabetes, hypertension, and heart disease.” Importantly, the Guidelines emphasize healthy eating patterns to increase population health, rather than focusing on individual nutrients or foods. The Guidelines state that Americans should focus on maintaining healthy body weight through nutrient adequacy over their lifespan. Reading between the lines, the Guidelines seem to advocate that Americans should avoid so-called “fad diets” that can lead to “yo-yo” weight fluctuations.

1US Department of Health and Human Services and US Department of Agriculture, Dietary Guidelines for Americans 2015-2010, 8th ed. (Dec. 2015) [hereinafter Dietary Guidelines]; United States Dept. of Agriculture, HHS and USDA Release New Dietary Guidelines to Encourage Healthy Eating Patterns to Prevent Chronic Diseases (Jan, 7, 2016)

2 See, Advisory Committee Members (Jan. 11, 2016); United States Dept. of Agriculture, Scientific Report of the 2015 Dietary Guidelines: Advisory Report to the Secretary of Health and Human Services and the Secretary of Agriculture (Feb. 2015)

Happy New Year! This blog entry will revisit and update the status of significant regulatory issues covered by the Well Done Blog in 2015 and assess 2016 FDA priorities in the food area.

2015 Overview

  • Office of Dietary Supplement Programs

    On December 21, 2015, the FDA announced the creation of the Office of Dietary Supplement Programs (ODSP).1 The program was formerly a division under the Office of Nutrition Labeling and Dietary Supplements, now known as the Office of Nutrition and Food Labeling. As discussed in our December 2, 2015 blog post, the Department of Justice brought a significant number of civil and criminal cases against the makers of dietary supplements in 2015. The creation of ODSP supports the mission of monitoring the safety of dietary supplements and taking action against entities that present a risk of harm to the consumer.

  • “Natural” Label Claims

    In 2015, the FDA received three Citizen Petitions asking that the agency define the term “natural” for use in food labeling. The term “natural” has been the subject of many food labeling lawsuits, as mentioned in our November 19, 2015 blog post. In direct response to requests from the public, the FDA has extended the comment period on the use of the term “natural” in food labeling to May 10, 2016.2 The Morgan Lewis FDA team is currently working on an analysis of the comments submitted to date. Please contact the FDA team if you are interested in submitting a comment.

  • Food Safety and Modernization Act (FSMA) Regulations

    As discussed in our November 16 blog post, in late 2015, the FDA published three final rules under FSMA: the Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety rule),3 the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP rule),4 and the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Accredited Third-Party Certification rule).5 These rules implement sections of FSMA geared toward protecting the US food supply. As discussed below, the FDA plans to take further action to implement sections of FSMA in 2016.

  • Menu Labeling Requirements

    As discussed in our blog posts of December 4, 2014 and July 13, 2015, FDA released its final rule on menu labeling in restaurants on December 1, 2014, and later extended the date for compliance from December 1, 2015 to December 1, 2016. The rule will require restaurants and similar retail food establishments that (1) sell “restaurant-type food,” (2) are part of a chain of 20 or more locations, (3) do business under the same name or slight variations of each other, and (4) offer for sale substantially the same menu items as the other business locations, to disclose calorie information on menus and menu boards.

  • New York Sodium Warning

    As discussed in our December 11, 2015 blog post, the New York City Department of Health and Mental Hygiene Board of Health (Board of Health) Sodium Warning Label Rule went into effect on December 1, 2015. The Rule requires food service establishments in New York City with 15 or more locations nationwide to provide a warning for menu items that contain 2,300 mg or more of sodium. New York City is the first city in the United States to require chain restaurants to include sodium warnings on menus or menu boards. Chains with 15 or more locations have 90 days to comply with the new rule before they face a $200 fine. The rule elicited responses from the National Salt Institute and the National Restaurant Association. The National Restaurant Association filed suit against the Board of Health, claiming that it did not have the authority to require such a warning. We will monitor this lawsuit and provide updates in 2016.

On December 1, the New York City Department of Health and Mental Hygiene Board of Health (Board of Health) Sodium Warning Label Rule went into effect.1 The Rule requires food service establishments in New York City with 15 or more locations nationwide to provide a warning for menu items that contain 2,300 mg or more of sodium. Menu items that fall under the rule include “combo” items (e.g., “order-by-number” meals that might include a soup and sandwich or hamburger and French fries).2 New York City is the first city in the United States to require chain restaurants to include sodium warnings on menus or menu boards. Chains with 15 or more locations have 90 days to comply with the new rule before they face a $200 fine.


On September 9, 2015, the Board of Health unanimously adopted a resolution requiring a sodium warning on food items with high sodium content (2300 mg or greater).3 In its Statement of Basis and Purpose, the Board of Health stated that cardiovascular disease is the leading cause of death in New York City, and hypertension is a major risk factor in heart disease. The Board found that Americans—and particularly New Yorkers—consume excessive amounts of sodium. The Statement of Basis and Purpose cited a 2010 study that showed that New Yorkers consumed an average of more than 3,200 mg of sodium per day, well above the recommended limit of 2,300 mg.

On November 17, the Department of Justice (DOJ) issued a press release announcing that it and other federal agencies have slapped more than 100 makers and marketers of dietary supplements with civil and criminal cases over the last year. The press release highlighted a criminal indictment that was recently unsealed in which the DOJ accused a supplement manufacturer and many of its officers of violating the Food, Drug, and Cosmetic Act (FDCA) as well as committing federal wire fraud, obstruction, and conspiracy. According to the indictment, the defendants allegedly made false statements to the public and the FDA about certain imported ingredients, used falsified certificates of analysis for phony “plant-based” ingredients manufactured by Chinese chemical suppliers, and surreptitiously continued distributing a dietary supplement, even after learning that it could lead to serious liver damage.

Although the criminal indictment represents an extreme set of alleged facts, the DOJ’s press release sends a strong message that the agency intends to sweep far and wide. In addition to featuring a criminal prosecution, the press release also highlights civil actions brought by the DOJ and Federal Trade Commission (FTC) involving the FDA, the Department of Defense, the Internal Revenue Service, the US Postal Inspection Service, and the US Anti-Doping Agency. Many civil cases filed by the DOJ and FTC (some of which date back to November 2014) target less extreme conduct, including alleged misbranding due to claims about products’ intended uses and alleged Current Good Manufacturing Practice issues. The DOJ’s press release signals proactive and coordinated enforcement in the area of dietary supplements and an intent to investigate and prosecute manufacturers and retailers alike.

Read the full press release.