FDA Food Labelling Requirements

• Food labelling is required for most prepared foods like breads, cereals, canned, and frozen foods, snacks, desserts, drinks. Nutritional Labelling raw produce like fruits, vegetables, fish, is voluntary.
• A food label is the primary mode of communication between the food company and the consumers.
• AS per FD&C Act nutritional labelling, content and claims have to comply with specific requirement as mentioned in the FD&C Act.

1) Reviewing labels for format verification as per FDA requirements
2) Supplement Fact + Nutritional Fact Label review
3) Health Claim Review
4) Labelling Statement Review
5) Disclaimer content and format
6) Ingredient Review
7) Detailed report of recommended revision of your label provided by our FDA Regulatory Expert
8) one-on-one expert assistance with respect to your label and re checking of modified/revised label.

Some of the common FDA Food Labelling Requirement

All food products that are packaged in advance of sale need to be completely and correctly labelled before being offered for sale.
The labels need to have the following information on them –
• Common or usual name of the product – fully descriptive and not misleading
• Net quantity statement
• Name and address of the producer, manufacturer, or distributor
• Ingredient statement , with ingredients listed in descending order of predominance by weight with the proper identification of food allergens.
• Nutrition Facts label following FDA approved format regulations (unless exempt).

FDA Food Labelling Requirement – Frequently Asked Question

• Does FDA Pre-Approve Food Label before placing the product in the market?

NO FDA dose not approve or disapprove labels prior to marketing of the product, the manufacturer or the seller is responsible to make sure the labels are complying with the FDA regulations.

FDA randomly checks the labels for compliance, and if found non-compliance it can result in detention of the product and issue of warning letters. One can view such warning letters for non-compliance on US FDA website

Fdapals as a Third-party Expert can help you verify the Label by reviewing the same for FDA regulatory compliance.

• Which Food is Exempted from Labelling requirement ?

Most of the Food are required to follow Food Labelling requirement while Raw produce like fruits, vegetables, fish are exempted from Nutritional Fact labelling.

• Is there are change in Nutritional Fact labelling requirement?

FDA updated the Nutritional fact labelling requirement in 2016 this update was done to make it easier for consumer to make better informed choices . The new Label reflects updated scientific information, nutrition research and public input.

• Who is responsible for Regulation of Food Labels in USA?

Generally, USDA – United State Department of Agriculture and US FDA – United States Food and Drug Administration are the 2 bodies involved in the regulation of food labels

• What will happen if my labels are in non-compliance with FDA regulations?

Non-compliance of food labelling requirement can lead to commercial loss and legal risk for your firm for examples

a) FDA can initiate Sanctions like – warning Letters, Detention Notice
b) Recall of products from market for undeclared allergens
c) Lawsuit for improper health/marketing claims

• Do Dietary Supplements needs to be evaluated for Labelling requirement?

Yes, Dietary Supplements product are required to comply with FDA Labelling requirement under Dietary Supplement Health and Education Act of 1994 and FDA regulations.