Labeling your product is so much more than listing what it does and what it contains on the outside of the package. At its best a label provides the necessary information for consumers to feel safe and sure in their choice, at its worst a label can be misleading and dangerous to those who place their trust in what a company is selling to them. Luckily, the truly bad labels do not get through to market due to the highly regulated environment that the U.S. government has established.
In fact, a large percentage of product rejections and detentions are a result of improper labeling. The Food and Drug Administration (FDA), Federal Trade Commission (FTC), Customs and Border Patrol (CBP) and various other government agencies (OGAs) all have requirements and expectations that need to be fulfilled in order to have a compliant label.
Depending on the product there are various boxes that need to be checked so that your label meets the standards for selling in the U.S. market. It is up to the manufacturer, distributer, or importer to understand these rules and regulations and take the necessary actions towards compliance. Whether you are a small business or a large corporation, based outside of or within the U.S., have one product or a multitude of products, it is imperative that your labels accurately follow the specific conditions for labeling compliance in order to be distributed to the consumer.
FDA Labeling Basics
Regardless of your product there are certain things that need to be on a label. You will see the following for FDA regulated products, but also any consumer good in the market.
- Statement of Identity – What is it? (this is separate from the brand name, for example: “facial tissue” as opposed to “Kleenex”)
- Quantity statement – How much product is here?
- Responsible Party Statement – Who is responsible for the product? (for example, the manufacturer and end distributor)
There are also general elements that are required for each individual commodity. Some of these include (but are not limited to) the following:
- Food: nutritional information unless exempt (Nutrition Facts Panel), ingredient list, allergen declaration unless exempt, and special claims
- OTC Drugs: adequate directions for use (what do you take it for, what are the signs and symptoms, what are the warnings), drug ingredient list, and a domestic entity to which consumers can file complaints
- Dietary Supplements: supplement labeling (similar to nutrition labeling), allergen declaration, ingredient list and domestic entity for consumer complaints
- OTC Devices: adequate directions for use as necessary, domestic entity for consumer complaints, and other warnings, for devices requirements can shift after the classification of the device (one of the trickier commodities)
- Cosmetics: similarly, an ingredient declaration, net contents, and required warnings
On top of the general rules there are other requirements that need to be met. For instance, the U.S. Customs and Border Patrol (Customs) requires that labels identify where the product was made (Country of Origin declaration for non-U.S. goods). Furthermore, there are requirements that are even more separate from the general requirements depending on your specific commodity. For example:
- Drugs: Directions for use and warning
- Foods: Nutrition Facts Panel
- Seafood: Seafood HACCP Regulations
Why is Labeling necessary?
The FTC regulates all forms of advertising. FDA regulates the content and form of labels for food, cosmetics, dietary supplements, devices and drugs. Labels are simply a special form of advertising, so both FTC and FDA regulate them. FDA reviews labels for compliance and to see that you meet the basic requirements to be in the market. These general rules are looked at by multiple jurisdictions. Agencies which regulate product labeling have various enforcement options available to them, including detaining products at the border, issuing recalls, seizing products, and issuing restraining orders to halt distribution.
FDA and FTC hold the manufacturer and the distributor (importer) responsible for making sure required label information is easy to find and easy to read, and that it contains any disclaimers or warnings necessary to keep consumers safe (e.g., allergen labeling). Manufacturers, importers and distributors are held responsible for ensuring advertising claims and labeling (including website and social media) claims are truthful and not misleading.
Special Rules for Claims
If you would like to make claims for your products that go beyond the general labeling rules, then FDA has certain rules for that: specified rules for claims. FTC or FDA can make these specifications but typically FTC will determine the rules and FDA will enforce them. The most important element is to make sure your claims are not misleading. It bears repeating that claims must be truthful. In addition, claims need to be the same across all mediums of advertising (labels, websites, brochures, etc.) For more information on Claims and Claims Analysis see our page here.
How does Internet Marketing Relate to Labeling?
Internet marketing sites (particularly point-of-sale sites) and other marketing and promotional materials often fall within the scope of the legal term ‘labeling.’ So, FDA regulates them as well. Yes, that is correct: FDA regulates internet sales and FDA can (and often does) send Warning Letters (called ‘Cyber Letters’) to companies that make illegal or impermissible claims on websites that sell foods, dietary supplements, cosmetics, beverages, drugs, or medical devices. Once FDA finds a website that makes illegal claims about a dietary supplement or an OTC drug, for instance, FDA will target products sold through that website and will try to stop them from entering U.S. commerce. In a worst-case scenario, FDA will solicit and obtain the assistance of Customs or the U.S. Postal Inspection Service (Postal Inspectors) to track down the products and seize them.
FDA also actively searches the internet looking for illegal advertising claims for products. FDA will draw legal connections between illegal advertising claims and your imported products. Then FDA will find the imported products and stop them at the border issuing FDA import detentions or import refusals. Read more about this here: Internet Marketing.
Get Your Label Reviewed
FDA inspectors and compliance officers regularly review the labeling of regulated products when they are imported into the U.S.
If you are simply starting up or contemplating a new venture and need to know the expenses, timeframes and possible pitfalls regarding your product’s labeling and marketing requirements, talk to us. If you are a multi-national firm that has completed this process hundreds of times before but can’t keep up with the new rules and regulations involving labeling, we can help you as well.
Fill out the form below to have your labels reviewed for FDA and FTC compliance. Discounts available for multiple labels.