One issue that can lead to a recall is “mislabeling.” Mislabeling occurs when a food product’s label does not accurately reflect its ingredients. A common reason for a recall is improper identification of allergens. There are more than 160 foods that can cause allergic reactions in people with food allergies. The FDA recognizes the eight most common allergenic foods, which account for 90 percent of allergic reactions to food. Those are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. These eight foods and any ingredient that contains protein derived from one or more of them are designated “major food allergens” by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and require specific labeling.
If a product is not properly labeled, the consequences could be life-threatening. A person with severe food allergies could experience anaphylaxis, which could lead to constricted airways, severe lowering of blood pressure and suffocation by swelling of the throat. Sometimes symptoms start out mild and can become more serious in a very short time. Allergic reactions can include hives, flushed skin or rash; a tingling or itchy sensation in the mouth, face and tongue; lip swelling; vomiting and/or diarrhea; abdominal cramps; coughing or wheezing; dizziness and/or lightheadedness; swelling of the throat and vocal cords; difficulty breathing; and loss of consciousness.
Many instances of mislabeling are caused by cross-contamination, which occurs when an allergenic or undesired product comes into contact with the product but is not listed on the label. Food product producers, manufacturers and distributors must take care to accurately label their products that contain allergens and to prevent cross-contamination. If contamination is discovered, a recall is likely on the horizon. It is imperative to notify the FDA, USDA and consumers promptly to prevent injury and contain the problem.
The FDA and the USDA have helpful guidelines and reporting links on their websites. For more information, see https://www.fda.gov/Food and https://www.fsis.usda.gov.
]]>I must briefly digress: at this point, you may rightly be wondering what a “Food Service Establishment” is. According to the New York City Health Code, it is “a place where food is provided for individual portion service directly to the consumer whether such food is provided free of charge or sold, whether consumption occurs on or off the premises or is provided from a pushcart, stand or vehicle.” That definition seems broad enough to cover someone giving away potato chips out of a shopping cart, so the new regulation is replete with exemptions and qualifications – the most important being that only FSEs with 15 or more locations would be required to comply.
Returning to the action, the rule requiring the telltale salt-shaker icons was set to take effect on March 1. The National Restaurant Association took action, seeking a preliminary injunction in New York Supreme Court, but was originally rebuffed when the Supreme Court judge denied the injunction and ruled that the City could proceed to enforce the regulation. The Association appealed, however, and at the last moment – February 29 – the appellate court granted a preliminary injunction preventing the regulation from being implemented while the Association continues its legal action to invalidate it.
Restaurateurs with 15 or more locations that do business in New York City certainly will be staying tuned as the Association’s appeal proceeds, but other hospitality business would do well to keep an eye on things as well. Particularly in light of the FDA’s new menu-labeling requirements, if New York City’s would-be sodium warnings are upheld, those little salt shakers may be only the first of many symbols to adorn menus in any number of places.
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]]>The FDA has issued draft guidance regarding previously announced menu-labeling rules set to take effect on December 1, 2015. The scope of those rules, which require certain businesses to post nutrition information about food offered for sale, has raised questions for the hospitality industry.
The FDA’s draft guidance, issued on September 11, 2015, relates to last year’s nutrition labeling rules promulgated under the Patient Protection and Affordable Care Act, which requires certain “restaurants and similar retail food establishments” to disclose calorie information and provide a “succinct statement concerning suggested daily caloric intake” on or near menus and near self-service food and food on display. The rules, which apply only to restaurant-type establishments that are part of a chain with 20 or more locations doing business under the same name and which offer for sale “substantially the same menu items,” raised questions regarding their applicability to chain hotels that offer food in various capacities.
Four Key Takeaways
Conclusion
The FDA’s food labeling rules are complex and could impact the hospitality industry in a variety of ways. Licensors and franchisors that retain power over hotel restaurants’ menus and menu boards are not insulated from liability for missteps, and all hospitality chain executives, general counsel and franchisees should prioritize getting into compliance with the rules prior to the go live date of December 1, 2015.
Disclaimer: this E-Flash does not offer specific legal advice, nor does it create an attorney-client relationship. You should not reach any legal conclusions based on the information contained in this E-Flash without first seeking the advice of counsel.
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]]>The Safe and Accurate Food Labeling Act (“SAFLA”) serves largely to prohibit state and local governments from enacting laws requiring food products containing GMOs to be labeled as such. It also addresses “natural” labeling claims, which have been a hotly litigated issue in recent years.
SAFLA is premised on the notion that the presence of GMOs in a food product is not information that is material for distinguishing between such a food and a comparable food product not produced from or containing GMOs. Therefore, labeling is not necessary.
SAFLA does provide consumers, the food industry, trading partners, and other interested parties with a clear affirmation of safety for foods produced from, containing, or consisting of genetically engineered plants.
The bill now moves along to the Senate. If the Senate passes the legislation in identical form, it will be final once signed into law by the President.
There are two notable subjects addressed under SAFLA. First, no state or political subdivision of any state may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce any requirement regarding use of genetically engineered plants for use in a food product that is not identical to the notification program established under SAFLA. Second, SAFLA directs FDA to formally address “natural” claims on food product labels.
SAFLA Provides Guidelines for Voluntary GMO-Labeling
Title II of the Act addresses Genetic Engineering Certification. SAFLA establishes a voluntary genetically engineered food certification program under USDA. This certification program governs label claims regarding use or non-use of genetic engineering in food products.
The Secretary of Agriculture is responsible for establishing the voluntary genetically engineered food certification program which will govern labeling with respect to use of genetic engineering in food production. The program will establish standards for selling or labeling a covered product as being GMO-free, or produced without use of genetic engineering. This will ensure a nationally-uniform manner of labeling.
SAFLA Directs FDA to Define and Regulate “Natural” Claims
Title III addresses “Natural” food labels. Under SAFLA, a food is deemed misbranded if its labeling contains an express or implied claim that the food is “natural” unless the claim uses the terms that have been defined by, and the food meets the requirements established in, FDA promulgated regulations. Natural claims include the following: “natural,” “100% natural,” “naturally grown,” “all natural,” “made with natural ingredients” and any other terms specified by Secretary.
What can we expect if SAFLA is enacted?
If the legislation passes the Senate and is signed into law by the President, states will be prohibited from issuing mandatory laws for foods containing certain GMO and states will be prohibited from requiring foods containing GMOs to be labeled as such. Further, the legislation will prohibit state and local governments from regulating GMO plants.
States will also be prohibited from making it unlawful for companies to label products containing GMOs as “natural.” In place of state by state laws regarding “natural” labeling, FDA would be required to set formal requirements for “natural” labeling, something it has steadfastly avoided doing for years. Specifically, the legislation directs FDA to establish rules formally defining how “natural” labeling can and should be used on food products. FDA currently has only an informal policy stating that foods labeled as “natural” cannot contain any added colors, artificial colors, artificial flavors, or synthetic ingredients.
Companies would be permitted to voluntarily label foods that do or do not contain GMO ingredients, but they would not be required to do so. The legislation directs the Department of Agriculture to establish a voluntary nongenetically engineered food certification program that would govern labeling of non-GMO food products in a uniform manner across the country. This is modeled after the largely successful USDA Organics program. A program like this would relieve companies in the food industry from any obligation to disclose use of GMOs in their product.
Companies voluntarily labeling products as GMO-free would need to follow a standard established under the legislation. The legislation directs creation and implementation of a process to certify GMO-free food; therefore, a company labeling product as GMO-free may do so through the USDA-accredited certification process.
FDA would also be responsible for publishing and maintaining an online registry listing all genetically engineered plants intended to be used in food products. If a producer intends to use a non-regulated genetically-engineered plant in its food products, it would first have to receive FDA approval that the food is as safe as comparable foods.
What are SAFLA’s proponents saying?
Proponents of the bipartisan legislation argue that GMOs have been deemed safe by FDA and science has repeatedly found that they are not harmful or unsafe. Advocates stand behind findings of numerous renowned, well-respected groups that have all found GMOs to be safe. Such groups include FDA, World Health Organization, American Medical Association, National Academy of Sciences, and American Association for the Advancement of Science. Because GMOs have been found not to be harmful or unsafe, proponents argue that requiring products to be labeled as containing GMOs would cause undue alarm to consumers.
Without national legislation, a “patchwork” of state laws would increase prices, drive up food costs, and continue the rash of class action lawsuits currently bombarding food manufacturers. Variations in state laws also disrupts the free flow of goods across our nation and threatens interstate commerce. Consumers’ interests are also negatively affected by varying laws because the inevitable result is that product labels are inconsistent and present confusing information for consumers. The absence of a national standard risks spreading misinformation.
But, for now…
While it is unknown how long it will be before SAFLA is voted on in the Senate, members of the food industry should not be sitting back waiting and watching. Companies facing litigation involving “natural” or GMO-related labeling claims should certainly attempt to use this legislative action in defending (or at least staying) litigation against them. Stay tuned. Time will tell how both the judicial branch and legislative branch will react to last week’s passage in the House.
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