During 2016, the FDA undertook efforts to address the long overdue subject matter of importance to food producers and distributors, while federal courts contended with 2016’s coconut oil "superfood." This Strategic Perspective will highlight the top five areas most likely to have implications for the future of food litigation and regulation in 2017, including: (1) intentional adulteration of food from terrorist acts; (2) revision of nutrition labels after more than two decades; (3) exemption of roadside farms from facility registration requirements; (4) retail menu labeling; and (5) coconut oil "superfood" claims.
For the first time, the FDA will require both domestic and foreign food facilities to prepare and implement a written food defense plan that assesses and mitigates their potential vulnerabilities to intentional adulteration. While acts of intentional adulteration may take many forms, including acts of disgruntled employees or economically motivated adulteration, the purpose of the FDA’s Final rule is to protect food from acts (including terrorism) when the desire is to cause wide-scale public health harm. The Final rule establishes various food defense measures that an owner, operator, or agent in charge of a facility must implement to protect against the intentional adulteration of food (see Final food defense rules target wide-scale public harm and terrorism, May 26, 2016).
Public harm and terrorism. Rather than targeting specific foods or hazards, the FDA decided to combat the potential for wide-scale public harm or terrorism in the food industry by publishing a Proposed rule requiring mitigation strategies for processes in certain food facilities required to register with the FDA under the FDC Act (see Food facility measures to protect against intentional adulteration (terrorism) proposed, December 23, 2013). Facilities, other than small and very small businesses, will have three years after the effective date of July 26, 2016, to comply. Small businesses (fewer than 500 full-time equivalent employees) will have four years after the effective date to comply. Very small businesses must be prepared to comply with FDA requests for official documentation sufficient to show that the facility is exempt within five years of the effective date. These very small businesses must retain this documentation for two years.
The facility owner, operator, or agent also must establish and implement mitigation strategies management components to ensure the proper implementation of each food defense mitigation strategy. These components must include procedures for monitoring the mitigation strategies, corrective action to be taken if mitigation strategies are not properly implemented, and verification activities.
The iconic Nutrition Facts label, which was first introduced more than 20 years ago to help consumers make informed food choices and maintain healthy dietary practices, was updated with new designs and information to reflect the amounts of food that people currently eat. Two separate Final rules, effective July 26, 2016, will apply the changes to most packaged foods sold in the United States (see Nutrition Facts label gets ready for summer; reshapes serving sizes, trims fat info, May 20, 2016). The FDA will immediately exercise enforcement discretion on foods that contain "healthy" labeling when they are not low in total fat, but the fat profile is made up of mostly mono and polyunsaturated fats. The agency’s healthy labeling guidance informs manufacturers that it is currently re-evaluating previously established regulatory criteria (see ‘Healthy’ labeling to focus on current dietary recommendations for fats, nutrients, September 28, 2016).
Serving size. Over the last 20 years, research as shown that food package and unit size influences food consumption. For some food packages, consumers are likely to eat the entire contents in one sitting. Other food packages are conducive to sharing with others. Among other changes, in the Final rule, "Serving Sizes of Foods that Can Reasonably Be Consumed at One Eating Occasion," the FDA amended food regulations to establish new reference amounts customarily consumed (RACCs) by consumers in one single eating occasion. For example, the reference amount used to set a serving of ice cream was previously one-half cup but has been changed to two-thirds cup. The reference amount used to set a serving of soda has been changed from 8 ounces to 12 ounces. In addition, "dual column" labels must be used to indicate both "per serving" and "per package" calorie and nutrition information for certain multi-serving food products that could be consumed in one sitting or multiple sittings, such as a pint of ice cream or a 24-ounce bottle of soda. The FDA stressed that dual-column labels will allow consumers to easily understand how many calories and nutrients they are getting if they eat or drink the entire package/unit at one time. The compliance date of this final rule is July 26, 2018, for manufacturers with $10 million or more in annual food sales, and July 26, 2019, for manufacturers with less than $10 million in annual food sales.
Nutrition and Supplement Facts. In addition to aligning the Nutrition Facts label to consumers’ expectation of serving sizes, the Final rule titled "Food Labeling: Revision of the Nutrition and Supplement Facts Labels" requires the declaration of grams and a percent daily value (%DV) for "added sugars" to help consumers know how much sugar has been added to the product, as well as eliminate the display of "calories from fat" because research has found that the type of fat is more important than the amount. The FDA also has made minor changes to the Supplement Facts label found on dietary supplements to make it consistent with the Nutrition Facts label. Most food manufacturers will be required to use the new label by July 26, 2018, but manufacturers with less than $10 million in annual food sales will have until July 26, 2019, to comply with the new rules.
Food establishments that sell food products at a roadside stand, farmers’ market, or through a community supported agriculture (CSA) program were exempted from food facility registration requirements to allow the FDA better focus for its scarce inspection resources (see Some farms harvest registration exemptions from Final rule, July 13, 2016).
Resources. Under current regulations, food facilities that manufacture, process, pack, or hold food for consumption in the United States must register with FDA. However, establishments that are designated as "retail food establishments"— farms, restaurants, and certain other entities—are exempt from the requirement to register. The FDA has issued previous guidance on the definition of farms that would are exempt from the registration requirements (see Farm definition impacts food facility registration, November 19, 2014).
The Final rule amends the definition of retail food establishment to include new categories of food establishments based upon the "primary function of an establishment or a retail food establishment." The new regulations recognize the sale of food products directly to consumers as including: (1) the sale of food products or food directly to consumers by an establishment at a roadside stand or farmers’ market when such a stand or market is located other than where the food was manufactured or processed; (2) the sale and distribution of such food through a CSA program; and (3) the sale and distribution of such food at any other such direct sales platform as determined by the HHS Secretary—door-to-door sales, mail, catalog and internet orders, online farmers’ markets and online grocery deliveries, religious or other organization bazaars, and state and local fairs.
The FDA is providing final guidance designed to help restaurants and retail food establishments that are part of a chain with 20 or more locations, doing business under the same name, and offering for sale substantially the same menu items, to comply with the menu labeling requirements contained in section 4205 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) and the menu-labeling Final rule (79 FR 71156) (see Finally final: FDA releases ACA-mandated menu labeling requirements, December 1, 2014). The final guidance describes nutrition labeling that is required for foods sold in covered establishments, how this information (calorie and nutrition labeling) may be presented, and when exempt foods must provide nutrition labeling. The final guidance is intended as a companion to "A Food Labeling Guide," published by the FDA in January 2013. Enforcement of the Final rule associated with the guidance is set for May 5, 2017 (see Final menu labeling guide for restaurants issued, enforcement date set, May 5, 2016).
- Food Defense
- Nutrition Facts Label Gets a Refresh after 20 Years
- FDA Wants Focus, Farms Exempt From Registration
- Label Changes on the Menu for Restaurants
- Consumers Crack Food Manufacturers’ Tough Shell on Coconut Oil
In three separate decisions by federal courts in California, consumers saw their claims against food makers using coconut oil as a "superfood" favorably continue to wind through the system (Hunter v. Nature’s Way Products, LLC, No. 16cv-532-WQH-BLM, S.D. Cal., August 12, 2016; Boswell v. Costco Wholesale Corporation, No. SA CV 16-0278-DOC (DFMx), C.D. Cal., June 6, 2016; Jones v. Nutiva, Inc., No. 16-cv-00711-HSG, N.D. Cal., September 22, 2016).
Implied nutrient claim. The use of the term "healthy" in product labeling can constitute an implied nutrient content claim, according to a federal district court. The court concluded that coconut oil products manufactured by Nature’s Way brand and Schwabe North America, Inc., may have been labeled in a misleading and unlawful manner as a result of health claims. The court allowed a consumer class action claim to proceed, reasoning that the consumers sufficiently alleged that the product labeling made unauthorized nutrient content claims and misrepresentations regarding the healthy nature of the products. Specifically, the court explained, the use of the term "healthy" as an implied nutrient content claim is only permissible with respect to fat content when a product is defined as "Low Fat" (see Consumers take a crack at Nature’s Way coconut oil product labeling, August 17, 2016).
Deceptively healthy. Costco was unable to obtain dismissal of a putative class action brought by California consumers who claimed that Costco’s Kirkland Signature Organic Coconut Oil product was deceptively marketed with a variety of labeling claims intended to convince consumers that the product is healthy, when it is pure fat, almost all of which is saturated fat. The court found that the consumers had standing to sue and, at the pleading stage, had sufficiently alleged causes of action under California statutes governing unfair competition, false advertising, consumer legal remedies, express warranty, and implied warranty of merchantability (see Deceptive marketing claims against Costco’s coconut oil proceed, June 9, 2016).
Not a superfood? A customer who purchased coconut oil from Nutiva, Inc. had standing to challenge products he did not purchase because he alleged that the products were misbranded as a matter of law. The court found that a reasonable customer could, based on label statements that the food was a "superfood," believe that the product was healthier than butter and would not increase cholesterol levels. Although some of the statements, such as the claim that the product was better than butter, were subjective, within the context of the statements as a whole, the more subjective statements could contribute to the deceptive context of the branding (see Misbranding claims about the health of coconut oil ‘superfood’ survive, September 26, 2016).
Food Safety in 2017
While the FDA actions in 2016 were not as groundbreaking as previous years, food producers and distributors should be prepared for additional regulations and litigation in 2017 that may or not be related to food modernization efforts by the agency. Additionally, there is some uncertainty as to what a Trump Administration will bring in 2017 for the food industry. President-elect Trump campaigned on a platform of reduced regulations and deconstruction of the ACA, yet on the campaign trail, he was not as forthcoming with how he would handle the FDA. In a pre-election first 100 days’ action plan, he indicated that some reforms at the agency would include expediting drug approvals. Although it is apparent that President-elect Trump dislikes bureaucracy, the FDA was not immune to his fault-finding when he was exceedingly critical of food industry regulations on the campaign trail. Post-election, however, he has gone silent regarding his initial criticisms about the FDA’s food regulation. Whether President-elect Trump will now follow through and direct the FDA to lower the bar when it comes to food safety is unknown.
MainStory: StrategicPerspectives NewsFeed FoodNews
Interested in submitting an article?
Submit your information to us today!Learn More