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U.S. FDA Relaxes Menu and Nutrition Facts Labeling Requirements in Response to Pandemic

In response to the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) has temporarily relaxed some of its requirements concerning menu and nutrition labeling, and extended certain enforcement deadlines.

Menu Labeling

The FDA has announced that it “will not object” if, during this public health emergency, restaurants and retail food establishments do not meet menu labeling requirements requiring disclosure of calories and other nutritional information.

The FDA regulations  typically apply to restaurants and similar 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.

The FDA stated that this policy is intended to provide flexibility to restaurants and food establishments that may have to rapidly transition to take-out only or that are experiencing disruptions in their supply chains requiring substitutions. To provide further guidance, it has issued Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency.

Nutrition Facts Label Enforcement

As we previously reported, although January 1, 2020, was the deadline for many companies to implement the new Nutrition Facts label, the FDA earlier stated that it would not take any enforcement action for the first six months, or until after July 1, 2020. The FDA has now announced that it intends to work cooperatively with manufacturers for the remainder of the year, and “will not focus on enforcement actions

Year in Review: 2019 Food and Beverage Litigation and Regulatory Roundup

2019 was another active year for new regulatory activity and litigation targeting the food, beverage, and supplement industries.

In this roundup, Bryan Cave Leighton Paisner LLP presents a collection of regulatory developments, key court decisions, and notable settlements that were reached in 2019 and early 2020.

The highlights of this 2019 roundup include:

  • New federal legislation governing food labeling.
  • New regulations and a burst of litigation regarding CBD-based products.
  • An update on slack fill litigation.
  • Notable rulings, trials, and settlements.
  • Prop 65 and food safety update.
  • A preview of areas to watch in 2020.

We will continue our commitment to monitoring and analyzing industry trends in these areas and advising clients on legal and regulatory developments.

 

FDA Extends Enforcement of New Nutrition Facts Label Another 6 Months

Although January 1, 2020 was the deadline for many companies to implement the new Nutrition Facts label, the FDA states on its Industry Resources on the Changes to the Nutrition Facts Label web page that it will not take any enforcement actions for the first six months, or until after July 1, 2020.

The FDA initially set a general compliance date of July 2018. Manufacturers with annual food sales of less than $10 million were given an additional year to comply. In May 2018, the FDA extended those compliance dates “by approximately 1.5 years.”

The FDA has provided the following example illustrating what’s different about the new Nutrition Facts label:

Importantly, the new label requires:

  • Declarations for “added sugars” in grams and as a percentage of Daily Value (% DV);
  • Updated list of declared nutrients. Disclosure of vitamin D and potassium will be required. Calcium and iron will continue to be required. Vitamins A and C will no longer be required but can be included on a voluntary basis.
  • Continuing to retire “Total Fat,” Saturated Fat,” and “Trans Fat,” but no longer require “Calories from Fat,” since research shows the type of fat is more important than the amount.
  • Updated daily values for nutrients like sodium, dietary fiber and vitamin D; and
  • Updated serving sizes and labeling requirements for certain package sizes.

The FDA has also issued a non-binding

Congress Presses FDA to Act on CBD Regulations

Following statements by the U.S. Food and Drug Administration that cannabidoil (CBD) in food and beverage products remains illegal, and amid the patchwork of state laws and enforcement actions, a group of U.S. lawmakers, led by Reps. Chellie Pingree (D-Maine) and James Comer (R-Ky.), have urged the FDA to “quickly adopt a policy of enforcement discretion and to consider issuing an interim final rule to regulate CBD as a dietary supplement and food additive while simultaneously moving forward with a robust framework for evaluating the safety and accurate labeling of these products.” The letter stated that the agency’s “current regulatory posture on CBD has created significant regulatory and legal uncertainty for participants in this quickly evolving industry. We are discouraged by FDA’s estimation that a rulemaking process could span 3 to 5 years. We believe there are more expeditious measures that FDA could take that would establish regulatory clarity while pursuing enforcement actions against bad actors.”

In the U.S. Senate, Majority Leader Mitch McConnell (R-Ky.) reportedly took a different path in an effort to reach the same ends by proposing to amend the Senate appropriations bill to insert language that would compel FDA to issue temporary guidance on how it will enforce rules on the sale of products containing CBD. The proposed amendment would require the agency to inform Congress within 90 days about its progress in creating its regulatory policies on CBD and implement a temporary policy within 120 days.

The House of Representatives also received a

FTC Warns Companies Against Advertising CBD Products as Treating or Curing Diseases

The U.S. Federal Trade Commission has announced that it sent warning letters to three companies that sell “oils, tinctures, capsules, ‘gummies,’ and creams containing cannabidiol (CBD),” a chemical compound derived from the cannabis plant. The letters warn the companies, which have not been identified, that “it is illegal to advertise that a product can prevent, treat, or cure human disease without competent and reliable scientific evidence to support such claims.”

The FTC states that each company marketed its CBD products as being able to “treat or cure serious disease and health conditions,” such as relieving “’even the most agonizing pain’ better than prescription opioid painkillers,” or treating cancer, Alzheimer’s disease, multiple sclerosis (MS), fibromyalgia, cigarette addiction, colitis, schizophrenia, anxiety, depression, Lou Gehrig’s Disease (ALS), stroke, Parkinson’s disease, epilepsy, traumatic brain injuries, diabetes, Crohn’s disease, psoriasis, and AIDS.

In the letters, the FTC urges the companies to review all claims made for their products, including consumer testimonials, to ensure they are supported by competent and reliable scientific evidence. The letters also warn that selling CBD products without such substantiation could violate the FTC Act and may result in legal action that could result in an injunction and an order to return money to consumers. The letters instruct the companies to notify the FTC within 15 days of the specific actions they have taken to address the agency’s concerns.

In In April 2019, the FTC and the U.S. Food and Drug Administration issued similar joint warning letters to three companies

Bioengineered Food Disclosure Rules Finalized, Require Disclosure of “Detectable” GMOs

On December 21, 2018, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published its final rule implementing the National Bioengineered Food Disclosure Standard (NBFDS) signed into law by President Obama in 2016.   The NBFDS preempted state and local genetic engineering labeling requirements and charged AMS with developing a national mandatory standard for disclosing the presence of bioengineered (BE) food.  The rule takes effect on February 19, 2019, and implementation will be phased in over the next three years.

As we previously reported, the NBDS requires food manufacturers, importers of food labeled for retail sale in the U.S. and some U.S. retailers to disclose foods and ingredients produced from foods that are or may be bioengineered.  The final rule defines “bioengineered food” as any food that “contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature,” and excludes any genetically modified material that is “not detectable.”  Non-detectable amounts of modified genetic material do not require BE labeling

Disclosure can be through text, a symbol, electronic or digital link, or text message, as follows:

  • Text: Entities can state “bioengineered food” or “contains a bioengineered food ingredient” for multi-ingredient food.
  • Symbol: Entities can use a variation of the following symbol, which incorporates the word “bioengineered” and can be used in either color or black and white:

FDA Provides Guidance for New Nutrition and Supplement Facts Labels

On November 5, the FDA released non-binding guidance intended to answer questions related to Nutrition Facts and Supplement Facts Label and Serving Size final rules. As we previously reported, the rules were finalized in May 2016 and initially set a general compliance date of July 2018. The FDA has extended that deadline to January 1, 2020 for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales have an extra year to comply, until January 1, 2021.

The May 2016 rules require a revamped Nutrition Facts label that, among other things,

  • Increases the type size of certain nutrition information.
  • Requires declaring actual amount, in addition to percent Daily Value, of vitamin D, calcium, iron and potassium.
  • Requires declaring “Added sugars,” in grams and as percent Daily Value.
  • Updates the list of nutrients that are required or permitted.
  • Removes “Calories from Fat” because research shows the type of fat is more important than the amount, but continues to include “Total Fat,” “Saturated Fat” and “Trans Fat.”
  • Updates Daily Values for nutrients like sodium, dietary fiber and vitamin D based on newer scientific evidence.
  • Updates serving sizes to reflect the amounts that people are actually eating. For packages that are between one and two servings, the calories and other nutrients will be required to be labeled as one serving because people typically consume it in one sitting.

In connection with the May 2016 rules, the FDA provided the following example illustrating

FDA Delays Implementing Nutrition and Supplement Facts Label Rules

The FDA has announced that it is delaying implementation of the Nutrition Facts and Supplement Facts Label and Serving Size final rules.  As we previously reported, the rules were finalized in May 2016 and initially set a general compliance date of July 26, 2018, although manufacturers with annual food sales of less than $10 million were given an additional year to comply.

The FDA did not elaborate on the new timeframe for implementation, but stated in a revised online guidance that it will provide details of the extension through a Federal Register Notice at a later time.

The rules require a revamped Nutrition Facts format that would increase the type size of certain nutrition information, require mandatory declarations for “added sugars,” Vitamin D and potassium, impose a new definition of “dietary fiber,” and revise serving sizes for certain food products.

The FDA explained that the extension was in response to feedback from industry and consumer groups, and will balance industry’s request for more implementation time and to reduce costs, with the importance of minimizing the transition period during which consumers will see both the old and the new versions of the label in the marketplace.

Consumer Groups Sue FDA Over Delay in Implementing Menu Calorie Labeling Rule

In another FDA update, two consumer groups groups have sued the FDA over its decision to extend the compliance date for its calorie labeling rules, which require posting calorie information on all menu items. As we previously reported, just one day

Retailers and Other Food Importers Must Ensure Food They Import Meets U.S. Safety Standards

Requirements take effect today under the FDA’s new Foreign Supplier Verification Program (FSVP), which makes retailers and other businesses that import food into the United States responsible for verifying that the food has been produced in a manner that meets applicable U.S. safety standards.

FSVP is one of the seven foundational rules of the FDA’s Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

A central tenet of the FSVP is that the same preventive food safety standards should apply to all food consumed in the U.S., regardless of where the food is produced. The FSVP therefore requires that importers have a program in place to verify that their foreign suppliers are producing food in a manner that satisfies FSMA’s requirements for domestic food manufacturers, and also that the food is not adulterated or misbranded with respect to allergen labeling.

Importers must therefore establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.

What the FSVP Requires

Importers are required to develop, maintain and follow an FSVP for non-exempt food imported into the United States. The

FDA Releases Final Rule Allowing Voluntary Risk Reviews of Food Additives to Continue

The Food and Drug Administration (FDA) says its final rule allowing outside groups to evaluate food additive risks will streamline its “Generally Recognized as Safe” (GRAS) reviews.

The agency recently released its GRAS final rule for its food additive program, switching reviews from a more formal but slower “petition-based” process to a voluntary “notification” process.  For retailers with private label food products, that means that they or their vendors can continue to convene their own expert panels to review the safety of many food additives, and provide notice of their findings to the FDA.

Under the federal Food, Drug and Cosmetic Act (FD&C Act), any substance that is intentionally added to food is a food additive that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.

The use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food, which requires a substantial history of consumption for food use by a significant number of consumers.

Rule adopts pilot voluntary notification program.

The FDA’s rule implements as final a pilot notification program under which food makers can convene their own expert panels to prepare GRAS reviews and provide notice to the

New Federal Law Will Require Disclosure of GMO Content in Food

A new federal law will require food makers to disclose when foods contain genetically modified ingredients.

The law, which was recently signed by President Obama, will require such food products to be labeled with text, a symbol, or an electronic code readable by smartphone indicating the presence of GMOs. Small businesses will also have the option to label food products with a telephone number or Internet website directing customers to additional information.

The U.S. Department of Agriculture (USDA) has two years to draft regulations concerning which products require such disclosure, and additional details concerning what food makers must do to comply. After the regulations are finalized, food makers will have at least another year before the law takes effect.

Law preempts state and local GMO labeling laws.

The federal law preempts a similar Vermont law, Act 120, that took effect in July, as well as any other state or local GMO disclosure laws. The Vermont Attorney General’s office has announced it will suspend enforcement of Act 120.

Critics of the federal law, including Vermont’s congressional delegation, argued that it falls short compared with Vermont’s tougher labeling law requiring all foods with GMO ingredients to be labeled “produced with genetic engineering.”

Supporters of the federal law, including many in the food industry, say it avoids a state-by-state patchwork of laws in favor of a national disclosure solution.

Law will be federally enforced, but may fuel private lawsuits.

The law will be administered and enforced by the federal government, through the USDA.

The FDA Dishes Out Food Label Changes

The current food label will soon be no more. After two decades, the Food and Drug Administration (FDA) just finalized the new Nutrition Facts label for packaged foods. Making it easier for consumers to make better informed food choices, the FDA announced that the changes are based a combination of public input, updated scientific information, new nutrition and public health research, and more recent dietary recommendations from expert groups.

Highlights of the changes include:

The Refreshed Label 

  • While the label’s appearance will generally remain the same, to highlight certain information the new label includes changes such as increasing the type size for “Calories,” “Servings per Container,” and the “Serving Size” declaration, and bolding the number of calories and the “Serving Size” declaration to highlight this information.
  • In addition to percent Daily Value of vitamin D, calcium, iron and potassium, manufacturers must declare the actual amount. For other vitamins and minerals, manufacturers can voluntarily declare the gram amount.
  • To better explain the meaning of Daily Value, the footnote is being changed to read: “*The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.”

New Nutrition Science Information 

  • “Added sugars,” in grams and as percent Daily Value, will be included on the label.
  • The FDA updated the list of nutrients required or permitted to be declared and now requires that vitamin D and potassium are included on the label.
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