FDA Labeling

FDA LABELING

FDA's web-based application designed to perform customizable searches of over 140,000 labeling for human prescription drug; nonprescription drugs; and labeling for other products (e.g., animal nonprescription and animal prescription drugs, cosmetics, dietary supplements, medical devices, medical foods).

FDA’s labeling resources for human prescription drugs are primarily directed to industry staff who develop human prescription drug labeling. Human prescription drug labeling (1) contains a summary of the essential scientific information needed for the safe and effective use of the drug; and (2) includes the Prescribing Information, FDA-approved patient labeling (Medication Guides, Patient Package Inserts, and/or Instructions for Use), and/or carton and container labeling. For assistance on how to navigate this webpage and the associated FDA labeling resource webpages for human prescription drugs.

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.

1. Statement of Identity – What is it? (this is separate from the brand name, for example: “facial tissue” as opposed to “Kleenex”)
2. Quantity statement – How much product is here?
3. 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.
• 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 labelling). Manufacturers, importers and distributors are held responsible for ensuring advertising claims and labeling (including website and social media) claims are truthful and not misleading.

APPLICABILITY OF FOOD LABELLING REGULATIONS

The food labeling regulations require all “Prepackaged” or “Pre-packed food” to comply with the labeling regulations in India. Per the rules, prepackaged food means food placed in a package of any nature in such a manner that the contents cannot be changed without tampering and which is ready for sale to the consumer.

GENERAL LABELLING REQUIREMENTS

The following labeling requirements must be complied with by all prepackaged food sold in India:

• The label must be in English or Hindi, or the Devnagri language. In addition to the above, the title can contain Information in any other language, as required.
• The label must not contain Information about the food that could be deemed false, misleading, deceptive, or otherwise create an erroneous impression regarding the product.
• The label must be affixed to the container so that it would not easily be separated from the container.
• The contents or Information presented on the label should be clear, prominent, memorable, and readily legible by the consumer.
• If a wrapper covers the container, then the wrapper must contain necessary Information or make the label of the product inside readily legible by not obscuring.
• The name of the food must be mentioned along with the trade name and description. In case the food contains more than one ingredient, then a list of ingredients must be presented in descending order of their composition by weight or volume, as the case may be, at the time of its manufacture;

In addition to the above, there are various regulations concerning labeling that apply to multiple types of prepackaged foods. Hence, it’s essential to consult a qualified FSSAI consultant about the label before launch.

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