FDA Food Labeling Compliance: Requirements and Standards

Fda ComplianceFood and supplement packaging not only protects and preserves perishable contents, but the labels found on product packaging also facilitate direct communication with consumers. In addition to featuring brand messaging, logos, and graphics, food and supplement labels also convey important information about ingredients, nutrition, and production facilities.

Labeling accuracy and transparency are essential, shielding consumers from allergic reactions and other unintended, yet potentially catastrophic outcomes. With so much at stake, government agencies such as the Food and Drug Administration (FDA) regulate product labels, calling upon contract packaging companies to meet strict standards for food and supplement labeling. Compliance with established labeling standards is mandatory, so getting it right is an important concern for food and supplement manufacturers and their packaging partners.

US Labeling Standards Must Be Met

Global labeling requirements vary from region to region, but many countries with less stringent labeling standards are taking measures to strengthen requirements. In the United States, the FDA issues clear parameters that must be met, before food and supplements can legally be sold within the US.

Although compliance is expected from most packaged food manufacturers, some producers may qualify for exemptions, allowing them to bring goods to market without meeting general regulatory requirements. Food and supplement producers generating less than $50,000 in annual sales, for example, may not be required to include Nutrition Facts Labels on their products. In other cases, the number of full-time workers employed or the number of units sold annually may qualify for labeling exemptions. Under these special circumstances, the FDA may require makers to file annual exemption claims.

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Label Placement is Regulated by the FDA

Compliance with FDA labeling requirements relies on attention to detail. While the general standards put forth by the FDA are not overly complex, labeling requirements are very specific. In order to standardize regulations and ensure compliance across diverse brands and products, food and supplement labels are broken down into distinct parts.

The area of a package most likely to be front-and-center to consumers is known as the primary display panel (PDP). The PDP is strictly defined. On a traditional rectangular box, for instance, the PDP is comprised of the area determined by the box’s height times its width. On cans and other cylindrical packages, the PDP is considered 40-percent of the height times the circumference of the container. Another designated area of importance is known as the information panel or information space, which is located directly to the right of the primary display panel. On a traditional half-gallon milk carton, the PDP would be considered the “front” of the container, and the information panel would be found on the “side” of the carton.

The areas designated by the FDA are important, because the agency not only regulates the information labels contain, but also where the information is placed on each package.

Required Food and Supplement Labeling Elements

The basis for food labels accounts for several features made mandatory by FDA regulations. Among the information conveyed to consumers on food and supplement labels, contract packagers and manufacturers must include components such as:

Distributor, manufacturer, and packer information

In order to comply with US labeling requirements, food and supplement producers must include their company name on each package, along with a statement confirming their relationship with the package contents. This “manufactured by” or “distributed by” qualifying phrase includes the firm’s complete street address. The information is typically on the package’s information panel, but regulations also allow it to be placed within the primary display panel.

Ingredient statement

Food ingredient information must be included on the same panel as the manufacturing information mentioned above. Most often the statement is placed on the PDP or the information panel. The typeface used to describe ingredients must be clearly readable and measure at least 1/16″ tall.

Statement of identity

The statement of identity required on food and supplement labels is not the brand name of a maker. Rather, the statement is the legal name or description of the product. A product’s identity statement must be placed prominently on the PDP, with type that is at least one-half the size of the largest font seen on the package.

Quantity of contents

The amount of food found in each package is represented in the quantity of contents section of food packaging. Depending upon the goods contained in the package, quantities are expressed as either weights, liquid measures, or as a number of items contained in the package. The FDA requires the information to be placed in the lower one-third of the primary display panel. The height of type used to convey quantities is sized according to established FDA standards, which uses the overall display space on the PDP as a guide. On a package with less than five sq. inches of total area, for example, a type height of 1/16th of an inch complies with legal labeling requirements.

Declaration of allergens

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) stipulates strict labeling requirements designed to protect consumers from allergens. Under the terms of FALCPA regulation, packagers must declare the presence of major allergens. The declaration is placed on the PDP or information panel, adjacent to the nutrition facts label. Major allergens falling under the regulatory requirement include peanuts, milk, soybeans, fish, eggs, wheat, shellfish, tree nuts, and sesame. In order to comply with the food and supplement packaging requirement, allergens must be identified in parenthesis, within the ingredient statement, or in a separate plain language statement identifying allergens found in the product.

Nutrition facts label

A recognizable feature found on consumer packaged goods, the nutrition facts label conveys information about food products. The format of the familiar, standardized nutrition facts portion of food and supplement labels follows FDA guidelines, based-upon package size and contents. Nutrition facts labels include serving size, expressed as a common household measure or unit, as well as the total number of servings contained in each package. Mandatory nutrient listings are also shared on this part of the label, conveying percentages of fat, sodium, fiber, and sugar, among others.

Additional Labeling Considerations

In addition to meeting labeling standards established by the Food and Drug Administration, manufacturers may also elect to include nutrient content claims on packaging. Common examples include “low fat” and “sugar free.” When nutrient contents claims are made, regulators determine which claims are valid. A label containing a nutrient claim must also reflect the value of the nutrient in the nutrition facts panel.

Although product dating is not required under federal law, state agencies maintain unique labeling standards, outside FDA regulations. Expiration dates and best-by recommendations are mandatory in some markets, so manufacturers and contract packaging professionals must also account for local labeling laws when marketing food and supplements.

Labeling compliance is an essential component of food and supplement marketing; food producers are bound by state and federal labeling regulations. Adding value to their relationships with manufacturers and food and supplement distributors, experienced contract packagers are well-versed in FDA compliance.

Assemblies Unlimited provides complete contract packaging services across a wide range of product types and industries. With deep experience in FDA-compliant labeling and relabeling services, we are positioned to support your packaging compliance needs from concept to completion.

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