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Frequently Asked Questions
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1. What agency regulates food labeling?
FDA (the Food and Drug Administration) is in charge of food labeling for most food products in the U.S. A few exceptions are meat, poultry, and some egg products.
2. What laws, regulations, and rules govern food labeling in the U.S.?
On the federal level, the Food Drug and Cosmetic Act (FD&C Act) and FDA's regulations govern food labeling. Additional measures, such as FDA guidelines or state agency rules and regulations, may also govern food labeling.
3. What does FDA consider to be a “food” for the purposes of FDA food labeling?
The definition is sweeping and includes most articles used as food or drink (for humans or animals). The definition includes chewing gum, food additives, a wide variety of beverages, cookies, bottled water, dietary supplements, candy, cereal, rice and so on.
4. The FDA has labeling jurisdiction over domestic (U.S.) food products only, right?
Wrong. FDA has jurisdiction over both domestic and imported food products that are sold in U.S. interstate commerce. Imported foods are generally not excluded from FDA's labeling requirements.
5. Is an alcohol beverage a food and does it need to be labeled in compliance with FDA food labeling regulations?
Most alcohol beverages need to comply with TTB rather than FDA food labeling rules. One exception is low alcohol wines (wines containing less than 7% alcohol by volume). Another exception is beers that do not contain both malted barley and hops (e.g., they contain a grain other than malted barley, or malt beverage-type products made without hops). Products that fall within an exception must comply with FDA’s food labeling regulations.
6. What are the mandatory requirements on labels of food products?
There are many requirements for food labels, and specific regulations can apply depending on the actual food type or claims made on the label. Generally, the following must appear on all food labels:
- Net quantity of contents statement;
- Brand name;
- Statement of identity;
- Nutrition facts panel;
- Ingredients statement;
- Name and address of manufacturer, packer, distributor, importer, or similar; and
- Declaration of all major allergens.
7. Is there a process where FDA approves a food label before the product is sold at market?
There is no pre-market approval for food labels within the jurisdiction of FDA. That means, a food producer can put its product in the marketplace without a label approval from the federal government. However, it is important to consider that FDA can issue agency actions, such as warning letters, if it finds a product is adulterated, misbranded, mislabeled or otherwise not in compliance with federal rules and regulations. By contrast, for most alcohol beverages, TTB requires and provides pre-market review and approval.
8. If there is no pre-market approval, how do I know my label is correct?
FDA usually will not review a label for compliance, so the company has a heavy responsibility, to make sure the label is correct, before the product enters the marketplace. One option is for the company to design and review the label against applicable regulations on their own. Another good option is to work with a food lawyer who may be more familiar with the rules. This can save money and time to the extent the reviewer can point out issues before printing and before the product goes to market. If you wish, an attorney at Lehrman Beverage Law would be happy to review your food label and advise about its compliance with federal rules.
9. Is there any way I can exclude a Nutrition Facts Panel on my food label?
If you qualify for a Small Business Nutrition Labeling Exemption, you do not need to include the Nutrition Facts Panel. To qualify for the Exemption, you must apply to FDA and meet other criteria (such as the number of products sold per year, and the size of your company). An attorney at Lehrman Beverage Law can advise whether the Exemption may be an option for your company or product.
10. Must the food label include a list of ingredients?
An ingredient list is required on all food products that have more than one ingredient. The ingredients must be listed by their common or usual names in descending order of predominance by weight. The ingredient statement is an important aspect in food labeling because it allows the consumer to identify what is contained within the product and avoid either undesirable ingredients or ingredients to which the consumer is allergic. Generally speaking, the ingredients list must show any FDA-certified colors (e.g., FD&C Yellow No. 5).
11. Can I call my food product anything I want?
There are rules and regulations that may restrict or mandate whether products have a specific Statement of Identity (“SOI”) depending on ingredients in the product, how the product is manufactured or processed, and other requirements. For example, FDA regulates what may be called “yogurt,” but regulations governing the term “Greek Yogurt” do not currently exist.
12. What type of claims found on food labels are regulated by FDA?
FDA regulates a variety of claims found on food labels, ranging from nutrient content claims to health claims to structure function claims. Some of the most common types of claims that are found on food labels include the following:
- Light or Lite;
- More, Added, Extra, Enriched (or similar);
- Good source, Rich in, Excellent source of (or similar); and
13. What does FDA consider to be a major food allergen?
Under the Food Allergen Labeling and Consumer Protection Act, the major food allergens are:
- Crustacean shellfish
- Tree nuts
If an ingredient contains a protein that derives from one of the above, it is also considered a major food allergen. When the food contains such allergens, the product must be labeled in a particular way.
For more information about this topic, contact Lindsey Zahn.