The Food and Drug Administration (FDA) recently issued a draft guidance on the agency’s voluntary recall process and announced the agency’s intention to notify the public faster when a product is recalled. The guidance aims to assist and provide recommendations to industry and FDA staff regarding the use, content and circumstances for issuance of public warnings and public notifications for firm‑initiated or FDA‑requested recalls. In addition, the guidance discusses what information to include in a public warning, as well as the parties responsible for issuing it. Notably, the draft guidance does not specifically address recalls of alcohol beverage products regulated by the Federal Alcohol Administration (FAA) Act or the primary role of the Alcohol and Tobacco Tax and Trade Bureau (TTB) in seeking and monitoring recalls of such beverages. Comments on the draft guidance are due by March 20, 2018. Continue Reading FDA Releases Draft Guidance on Public Warnings and Notifications of Recalls
On November 7, the US Food and Drug Administration (FDA) published the latest in a series of industry draft guidance documents to help implement menu labeling and nutrient disclosure regulations applicable to chain restaurants (Draft Guidance). FDA guidance documents are advisory in nature and represent the views of the FDA at a given point in time. Accordingly, guidance is subject to change, but is useful for developing a compliance plan for retail establishments covered by the menu labeling regulations. Changes are usually incremental and based on agency experience and input from regulated industry members.
The FDA established a 60-day period for comments on the draft menu labeling and nutrient disclosure guidance. The comment period ends on January 6, 2018.
The current compliance date for menu labeling and nutrient disclosure regulations is May 7, 2018.
Implementation of federal menu labeling and nutrient disclosures by chain restaurants is a study in modern American political and administrative processes. For those who already tried to comply with the formal FDA regulations and prior guidance, an explanatory note about delays in the administrative process appears at the end of this post.
Two sections of the Draft Guidance explicitly address alcohol beverages.
- Guidance is offered for beer lists on menus and the discussion has broader application to wine and spirits products and cocktails that are standard menu items on chain restaurant menus.
- Sources of nutrient information for beer, wine and spirits are also discussed to provide an alternative to expensive laboratory testing for each brand that a manufacturer offers.
The Draft Guidance also:
- Includes several plain-language explanations of key terms in FDA regulations with useful distinctions between regular menu items and season or special items;
- Displays a number of graphics designed to assist retailers with standardized formats to communicate calorie content of various foods to consumers and to distinguish menus from marketing materials;
- Directs manufacturers and retailers to reliable sources and methods to prepare and display compliant nutrient disclosures; and
- Provides information on presentation of mandatory standard menu notices alerting consumers to the federal government’s recommended 2,000 calorie diet and availability of nutritional information for standard menu items upon request to a server or manager at a retail establishment.
The FDA guidance and the formal regulations use subjective terms about legibility (e.g., contrasting, clear and conspicuous). Those terms aim to ensure that information is consumer-friendly, but they could lead to nuisance complaints from regulators. FDA regional personnel and local inspectors under contract with the FDA will monitor compliance with menu labeling regulations. Since chains will, by nature, have locations in multiple jurisdictions, consistency in enforcement poses a challenge to industry and government.
To mitigate regulatory risks, a conservative approach is advisable to mandatory disclosures. All aspects of calorie and nutrient disclosure should be reviewed by counsel or a knowledgeable compliance professional. The review should start with the manner used to ascertain calories and nutrients and continue through preparation and publication of new and easy-to-read menus and nutrient disclosures. While the regulations will inevitably lead to a standardized portion of chain menus, the Draft Guidance does not inhibit traditional point-of-sale marketing materials, graphics and other creative elements in a menu or associated marketing materials.
Why has menu labeling taken so long?
- Menu labeling and nutritional disclosure requirements for chain restaurants are mandated by Congress in the Affordable Care Act of 2010 (better known as Obamacare).
- A four-year rulemaking process on menu labeling ended with publication of a final rule on December 1, 2014. That rule is unchanged as of November 2017, and is found at 21 CFR 101.11.
- A protracted debate occurred over the complexity of the rule and practical issues for food retailers who are responsible for compliance.
- In 2015, Congress enacted an appropriations bill, which included a “policy rider” ordering the FDA to not to spend money on implementation and enforcement of the final rule until one-year after publication of a guidance document. Because appropriations bills deal with funding and not substantive policy, Congress provided no additional guidance to the FDA to clarify issues raised in the rulemaking and public controversies surrounding menu labeling.
- The FDA published a “final guidance document” on May 5, 2016, with a new compliance date of May 5, 2017. Controversy continued, and the FDA extended the implementation date again to May 7, 2018.
- The November 2017 draft FDA guidance document discussed above could be revised again following the 60-day comment period.
- The compliance date remains May 7, 2018 unless extended again by the FDA or delayed by additional Congressional action.
On September 29, 2017, the US Food & Drug Administration (FDA) announced a proposal to extend the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule. For manufacturers with $10 million or more in annual food sales, the date will change from July 26, 2018, to January 1, 2020. Manufacturers with less than $10 million in annual food sales would receive an extra year to comply—until January 1, 2021.
FDA’s proposal addresses only the compliance dates. The FDA is not proposing any other changes to the Nutrition Facts Label and Serving Size final rules. While this rulemaking is being completed, FDA intends to exercise enforcement discretion with respect to the current July 26, 2018, and July 26, 2019, compliance dates. A copy of the public inspection version of the proposed rule can be found here.
Two consumer advocacy groups recently sued the Food and Drug Administration (FDA) for delaying the compliance deadline for the agency’s 2014 menu labeling rule for a fourth time. The menu labeling rule requires menu items offered for sale in restaurants with 20 or more locations to disclose nutritional information and the number of calories in each standard menu item. FDA and Congress previously extended or delayed compliance with the menu labeling rule three times in 2015 and 2016. Before the latest delay, the most recent “compliance date” for the menu labeling rule was May 5, 2017.
On March 13, the European Commission approved a report that calls on members of the alcohol beverage industry to develop a comprehensive self-regulatory system of ingredient and nutritional labeling for beer, wine, and distilled spirits. The Commission is composed of representatives of each member nation of the European Union (EU) with a range of administrative responsibilities and authority to develop and propose legislation for consideration by the European Parliament.
The European Commission characterizes access to ingredient and nutrition information as a right of EU consumers, and called on industry members to develop a self-regulatory proposal over the next year. Current EU policy on alcohol beverage labeling is analogous to US policy. The EU regulation on food labeling exempts alcohol beverages containing more than 1.2 percent alcohol-by-volume.
The European Commission proposal warrants careful attention by US alcohol beverage suppliers across all beverage categories. The initial industry response by European suppliers will likely start a lengthy process leading to new ingredient disclosures.
US regulations are largely based on the presumption that consumers have a working knowledge of ingredients in alcohol beverages. Alcohol & Tobacco Tax & Trade Bureau (TTB) and its predecessor agency considered and rejected mandatory ingredient labeling proposals several times since 1970s. TTB’s most recent assessment of ingredient and nutritional labeling of alcohol beverages was an advance notice of proposed rulemaking published in 2005 soliciting public input on the existing TTB policy. No further rulemaking activity followed the TTB inquiry.
Existing TTB regulations focus on disclosures of certain ingredients that pose unique health risks or allergic reactions. Industry members are permitted to disclose ingredients on a voluntary basis. A few alcohol beverages are subject to US Food and Drug Administration (FDA) regulations, which require comprehensive ingredient and nutritional labeling.
Many US products are exported for consumption in the EU. If a new system is adopted in the EU, producers in the US must provide ingredient and nutritional information to their customers overseas with no corresponding requirements in their home markets. EU suppliers are major players in the US market and may decide to voluntarily provide the same information to their American customers that they will ultimately have to provide in their home markets.
These dynamics will likely reinvigorate calls by consumer advocacy organizations and government agencies (e.g., Federal Trade Commission, Food and Drug Administration, and National Institutes of Health) in support of ingredient labeling of alcohol beverages in the US. In the current era of dwindling government resources, the European Commission’s call for an industry self-regulatory initiative provides an opening for a similar initiative in the US. Industry members and associations should monitor developments in the EU and consider appropriate responses directly to the EU initiative and to analogous proposals in the US.
An English version of the European Commission proposals is available here.
The Food and Drug Administration (FDA) recently took two actions involving the use of the claim “healthy” on food labels. First, FDA opened a docket to solicit comments on whether, and if so how, to revise the criteria that must be meet in order for a food to bear the claim “healthy.” This reflects changes in public health recommendations for various nutrients since FDA first published the criteria for making “healthy” food labeling claims in 1993. For example, FDA’s view of healthy dietary patterns now focuses on food groups and the type of fat rather than the total amount of fat in a food. Food manufacturers can continue to use the term “healthy” on foods that meet the current regulations while FDA further considers any comments submitted.
Second, FDA issued Guidance announcing that it does not intend to enforce certain regulatory requirements for products that use the term “healthy.” Specifically, FDA says it will not take enforcement action against a food that bears the claim “healthy” but which does not meet the regulatory definition of low fat provided that: (1) The amounts of mono- and polyunsaturated fats in the food are declared on the label; and (2) the sums of mono- and polyunsaturated fats are greater than the total saturated fat content of the food. Similarly, FDA will not take enforcement action with respect to the current regulatory requirement that any food bearing a “healthy” claim contain at least 10 percent of the Daily Value (DV) of vitamin A, vitamin C, calcium, iron, protein, or fiber if, instead, the food contains at least 10 percent of the DV of potassium or vitamin D. These two changes reflect the most-recent dietary guidance. For fat, the recommendations have shifted from limiting total fat intake to encouraging consumption of mono- and polyunsaturated fats. For mineral and vitamin content, potassium and vitamin D are now nutrients of public health concern, while vitamins A and C are no longer nutrients of public health concern.
A copy of FDA’s “Healthy” Guidance is attached here.
Most breweries have numerous dealings with the Alcohol and Tobacco Tax and Trade Bureau (TTB) and understand the need to comply with TTB regulations; this includes preparation for TTB audits and inspections. But the TTB is not the only federal agency with the authority to conduct a brewery inspection.
The Food and Drug Administration (FDA) also inspects food facilities, including breweries, to ensure they comply with FDA regulatory requirements. The FDA may conduct inspections as the result of routine surveillance, product quality issues, consumer complaints, or recalls. The agency also may conduct inspections to follow up on a previous inspection or an FDA enforcement action. The FDA also contracts with state and local food protection programs to conduct inspections and provide certification and training.
The US Food and Drug Administration (FDA) has released final guidance stating its view that sweeteners derived from sugar cane should not be declared in the statement of ingredients as “evaporated cane juice.” FDA’s view is that the term “evaporated cane juice” is false or misleading because it suggests that the sweetener is fruit or vegetable juice or is made from fruit or vegetable juice, and does not reveal that the ingredient’s basic nature and characterizing properties are those of a sugar.
FDA’s guidance recommends that ingredients currently labeled as “evaporated cane juice” be relabeled to use the term “sugar,” optionally accompanied by a truthful, non-misleading descriptor to distinguish the ingredient from other cane-based sweeteners. Such a descriptor could be a coined term, and can be used to distinguish the ingredient from white sugar and other sugars by describing characteristics such as source, color, flavor or crystal size. FDA would expect such a descriptor to appear before the common or usual ingredient name “sugar.”
FDA has published as part of the Food Safety Modernization Act (FSMA) a final rule concerning mitigation strategies to protect food against intentional adulteration. The rule will require domestic and foreign food facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (FFDCA) to address hazards that may be introduced with the intention to cause wide scale public health harm. More specifically, under this regulation, both domestic and foreign food facilities are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Facilities will now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to the vulnerable areas receive appropriate training and maintain certain records.
This week, the Food and Drug Administration’s (FDA) Director of the Center for Food Safety and Applied Nutrition (CFSAN) formally announced that the agency will delay enforcement of its final rule entitled “Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments.” The statement marked the second time the agency extended the compliance deadline. Enforcement of the menu labeling rule was scheduled to take effect on December 1, 2016. The date that the FDA will begin enforcing menu labeling provisions is unknown at this time. The delay is the result of a provision in a federal appropriations law that prohibits the FDA from using funds to implement, administer, or enforce the menu labeling rule until one year after the agency issues its final, Level 1 guidance on nutrition labeling of standard menu items in restaurants and similar retail food establishments. FDA has yet to issue that final guidance.