The next time you are walking the aisles of the grocery store, ask yourself “Who is responsible for regulating the labeling of these packaged foods?” In the U.S., regulations from multiple agencies apply to most products, but each packaged food has a principal agency responsible for ensuring its proper labeling.
Take our quick quiz and test yourself – who regulates the labeling of these packaged foods?
SO, how did you do? Did you correctly answer which is the primary agency responsible for regulating packaged foods at your grocery store?
FDA has regulatory responsibility for all other packaged foods.
You may know that the United States Department of Agriculture (USDA) is responsible for meat and poultry products, egg products that are out of the shell, and Siluriformes fish and products. The Alcohol and Tobacco Tax and Trade Bureau (TTB) is responsible for distilled spirits, certain wines, and malt beverages. The FDA has regulatory responsibility for all other packaged foods. This authority includes protecting the public health by assuring that foods are safe, wholesome, sanitary, and properly labeled.
The FDA’s authority to regulate and enforce labeling comes from the Food, Drug, and Cosmetic Act, which was passed in 1938. The FD&C Act defines the terms food, drug, and cosmetic, in addition to the terms label and labeling.
So, what should manufacturers be aware of when developing labels? Let’s look at three keys you need to know.
1. What is a label?
While this seems like a simple question, the reality is more complex. The FD&C Act defines a label as any display of written, printed, or graphic matter on the immediate container. Further, it defines the term labeling as all labels and other written, printed, or graphic matter that are on any article, on any of its containers or wrappers or accompanies such article. Examples of labeling include an open box used to display food in the store, pamphlets displayed next to a product, online information, or even information in a magazine.
Internet can be considered labeling.
Further, internet content will fall under the FD&C definition of labeling when the food product can be purchased online or if the label includes the website address. Websites that are considered labeling must have accurate information that is truthful and not misleading. Information included on these websites will be looked at by the FDA and any false information will be considered misbranding.
Even if the website does not meet the definition of “labeling,” the FDA will often still look at websites to ensure that improper claims such as drug claims are not being made.
2. What key issues are faced by manufacturers when labeling?
Adulterated food and misbranding are two of the key issues faced by manufacturers when labeling products.
Adulterated Food – While the addition of ingredients that are not safe or are not allowed is the adulteration people are most familiar with, a product will also be considered adulterated if there is an absence, substitution, or addition of an ingredient for the purposes of fraud. Examples of this include omission of any valuable ingredient from the product when the ingredient is listed on the label, or substitution of an ingredient listed on the label.
Economic deception is considered adulteration.
A product will also be considered adulterated if it is concealing damaged or inferior ingredients, or the addition of any substance to increase weight or appearance of value or reduce quality. A simple example of this is water. Because water is inexpensive, adding more to a food to increase the weight would be profitable. But the economic deception would be considered adulteration.
Misbranding – Misbranding is one of the most common issues manufacturers have with their food labels. A food is misbranded if the label fails to declare the mandatory labeling information, including the common or usual name of the food, the net quantity of contents, the ingredient statement with allergens disclosed, the manufacturer’s or distributor’s name and place of business, and nutrition information (with some exceptions).
Misbranding also applies to misleading information. A label may be considered misbranded if the information is false or misleading, if a container is made, formed, or filled in a way that is misleading, or if the required label information is not conspicuous. A bag of chips that is filled halfway with chips and halfway with air could be considered misleading because the consumer believes there should be more food in the package. Another example of misbranding would be if the font color for required label information is too close in color to the background color, and the consumer cannot easily read it.
While they may seem straight forward, fully understanding and ensuring label compliance with these and other issues is much more complex.
3. What allergens must be labeled?
The 2004 Food Allergen Labeling and Consumer Protection Act (FALCPA) amended the FD&C Act. It identifies the eight major food allergens in the United States at that time and requires that they be declared on the labeling of food products that contain them. FALCPA is a self-implementing law so there are no additional regulations adopted to enforce or further define the law. However, the FDA did provide guidance documents to assist manufacturers in applying the law. The major eight food allergens in the U.S. at that time were Milk, Tree Nuts, Eggs, Peanuts, Fish, Wheat, Crustacean Shellfish, and Soybeans.
In April of 2021, Congress amended FALCPA to include sesame as the 9th major allergen in the U.S. Companies have until January 1, 2023, to come into compliance for sesame. This will add a new level of complexity to labeling, among many other regulations that must be met.
The key to complying with these and other regulations is preparedness. Our upcoming Labeling of FDA Food Products seminar on Sept. 15-16 and 22-23 can provide this and a wealth of other expertise for you and your team.
Should you have any questions or need more information, please email us at info@aibinternational.com.
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