June 5, 2008
INGREDIENT LABELING LAWS
By: Daniel Duffy, Principal Analyst
You asked for a summary of federal ingredient labeling laws, especially those relating to allergens. You also asked for summaries of the comparable laws in Connecticut, Massachusetts, New Jersey, New York, and Rhode Island.
The federal Nutrition Labeling and Education Act (NLEA) of 1990 amends the Food, Drug and Cosmetic Act (FD&CA). It requires most food to bear nutrition labels and prescribes their form and content. They must state, among other things, the number of calories per serving and the amounts of fat, cholesterol, sodium, and fiber. Food that does not comply is deemed misbranded and invokes FD&CA's enforcement provisions.
NLEA also preempts state food labeling laws. Specifically, it prohibits states from establishing or enforcing labeling requirements that are different from federal law. Federal law allows states to enforce the federal requirements.
The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 further amends the FD&CA. It requires food labels to state the presence of the eight major food allergens identified by the act. They are: milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, and soybeans. The Congressional findings state than the eight major allergens are responsible for 90% of all food allergies.
Connecticut and the four other states all have laws that are counterparts to the FD&CA. Connecticut's law bans the sale of misbranded food and empowers the consumer protection commissioner to embargo misbranded food.
Nutrition Labeling and Education Act
The federal Food, Drug and Cosmetic Act of 1938 was amended in 1990 to require, for the first time, nutrition labels. Before 1990, nutrition labeling was voluntary. Under the Nutrition Labeling and Education Act (NLEA, P.L.101-535), a food is deemed “misbranded” unless it bears a nutrition label stating the:
1. serving size or other common household unit;
2. number of servings per container;
3. number of calories per serving and derived from total fat and saturated fat;
4. amount of total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, total protein, and dietary fiber per serving or other unit; and
5. vitamins, minerals, or other nutrients, subject to certain conditions.
NLEA orders the Food and Drug Administration (FDA) to prescribe nutrition labels that convey nutrition information to the public in a way that can be readily seen and understood in the context of a total daily diet. It also requires the FDA to establish standards to define serving sizes and allow other information to be included. Further, it directs the FDA to issue voluntary guidelines to provide nutrition information for raw agricultural commodities and fish.
The act establishes a number of exceptions, such as for food sold for immediate consumption in restaurants or that contains insignificant amounts of all the nutrients and does not make a claim about its nutritional value.
It prohibits, subject to exception, a state from establishing or enforcing any requirement for a food that is subject of a standard of identity or a labeling requirement that is not identical to the federal act. It allows states to petition for an exception for a requirement that would not cause a food to violate federal law, would not unduly burden interstate commerce, and is designed to address a particular need for nutrition information that is not met by federal law. The effect of the preemption in NLEA is discussed in the enclosed report, Food Safety: National Uniformity for Food Act, Congressional Research Service, Porter, January 23, 2007 (Hyperlink to enclosed report).
Food Allergen Labeling and Consumer Protection Act of 2004
The FDC&A was amended again to require food labeling to list in common language any of the eight known major food allergens and their food source contained in a product (P.L. 108-282). The requirement applies to raw agricultural commodities, spices, flavorings, colorings, and incidental additives. The allergens are: milk, egg, fish (e.g., bass, flounder, or cod), crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans. The requirements also apply to food ingredients that contain protein derived from any of the allergens. The act exempts “highly refined oil” derived from one of the allergens.
The Congressional findings state that:
1. approximately 2% of adults and 5% of infants and young children suffer from food allergies,
2. roughly 30,000 individuals require emergency room treatment and 150 individuals die because of allergic reactions to food each year,
3. the eight types of food identified in the act account for 90% of food allergies,
4. there is no cure for allergies,
5. a survey conducted by the FDA found that 25% of the sampled foods failed to list peanuts or eggs as ingredients on the labels, and
6. the number of recalls caused by unlabeled allergens was increasing rapidly.
FALCPA requires the FDA to report on the ways that food is unintentionally contaminated with major food allergens during the production process. The report must include:
1. estimates of how often this occurs;
2. ways that good manufacturing practices could reduce or eliminate this problem;
3. descriptions of (a) advisory labeling currently used by food producers, such as “may contain,” (b) conditions of food manufacture currently associated with different types of advisory labeling, and (c) the extent to which advisory labels are being used;
4. how consumers with food allergies would prefer to be informed about this risk; and
5. the number of food manufacturing facilities inspected within the previous two years and the inspection results related to labels properly advising consumers of the possible presence of major food allergens.
The report had to be issued by the end of 2006.
The act requires the FDA to publish a proposed rule to define and allow the use of “gluten-free” on a food label. It requires a final rule to be adopted four years after publication.
It requires the secretary to further food allergy research by convening a panel with the National Institutes of Health of nationally recognized experts in allergy and immunology. The panel must review current basic and clinical research efforts and recommend ways to enhance and coordinate them.
Further, it requires the FDA to pursue revision of the Food Code in cooperation with the states to establish guidelines for preparing allergen-free food in restaurants, grocery store delicatessens and bakeries, and elementary and secondary school cafeterias.
The required reports, studies, and regulations can be found at the following website, FDA Information About Food Allergens. The next Food Code revision is due in 2009.
The law deems food that is not properly labeled to be misbranded. Misbranded food may be voluntarily destroyed or recalled by the shipper or may be seized by U.S. Marshals in accordance with federal court orders. Violators may be prosecuted and are subject to fines and imprisonment. Federal courts may issue restraining orders to prohibit continued violations.
The law allows manufacturers or shippers to conduct voluntary recalls either on their own initiative or at the FDA's request.
Connecticut's Uniform Food, Drug and Cosmetic Act is a counterpart to the federal law. It is intended, in part, to safeguard the public health and promote the public welfare by protecting consumers from harm caused by merchandising deceit. The state law must be uniform with the federal Food, Drug, and Cosmetic Act and with the Federal Trade Commission Act, to the extent to which it bans false advertisement of food and it must promote the uniformity of such legislation and its administration and enforcement in and throughout the United States (CGS § 21a-91).
Ban on Misbranded Food
The Connecticut act bans, among other things, the sale in intrastate commerce of misbranded food (CGS § 21a-93). Among several grounds, a food is misbranded if (1) its labeling is false or misleading in any particular; (2) it is offered for sale under the name of another food; (3) it is a food for which no standard of identity has been established and (a) it falls below the standard of purity, quality, or strength which it purports or is represented to possess or (b) it does not bear its common or usual name of each ingredient, except that spices, flavorings, and colorings may be designated as such without being specifically named (CGS § 21a-102).
The act authorizes the commissioner to embargo food that he has probable cause to believe is misbranded. Once the commissioner has embargoed an item, he has 21 days to either begin summary proceedings to confiscate it or to remove the embargo. Proceedings are held in Superior Court by complaint and verified by affidavit. The complaint must include:
1. product description and location,
2. the name of the person who possesses it, and
3. a statement describing the adulteration or misbranding.
Once a verified complaint has been filed, the law requires the court to issue a warrant to seize the described article and to summon the person named in the complaint. The law requires the court to hold a hearing within five to 15 days from the date of the warrant. The court must order the food confiscated if it appears that it was offered for sale in violation of the act. If the food is not injurious to health and could be brought into compliance with the act if it is repackaged or relabeled, the court may order it delivered to its owner upon payment of court costs and provision of a bond to DCP assuring that the product will be brought into compliance (CGS § 21a-96).
Massachusetts (Mass. Gen. Laws T. 94 § 187), New Jersey (N.J. Rev. Stat. § 24:5-16), New York (N.Y. Agric. & Mkts. § 201), and Rhode Island (R.I Gen. Laws § 21-31-11) all have laws that are similar to Connecticut's and are counterparts to the federal law that allow for state enforcement.