Small Businesses Are Exempt from Many FDA Food Labeling Rules

Posted on by kginter

With so many food labeling rules and regulations, it can be hard for small businesses to understand how to label their foods, beverages, and dietary supplements. This is particularly confusing because small businesses don’t always fall under USDA and FDA labeling rules. You can waste time and money trying to adhere to standards intended for larger businesses.

I feel your pain and confusion so I’m here to try and make things a bit clearer for you! I want to share what I know because, in this economy, I think we need to do whatever we can to help small businesses make it. Disclaimer: this is my best understanding of small business label exemptions to USDA and FDA food label rules. It’s worth asking an industry colleague or FDA consultant to confirm this information.

Small Businesses  Exemptions from Food Labeling Requirements

There are many nutrition label requirements enforced by both the Food and Drug Administration (FDA) and The US Department of Agriculture (USDA) but not all of them are required to be followed by everyone, particularly small businesses. The following are the various FDA food labeling exemptions that your small business may qualify for based on your business size, as defined by your sales revenue or by your number of employees:

Small Business Exemptions from the Food, Drug, and Cosmetic Act:

These small business exemptions from the Food, Drug and Cosmetic Act apply to both packaged foods and dietary supplements, and allow producers to label without nutrition facts panels.

  • Small Business Exemption #1: No need to file with the FDA

a) Retailers with total annual gross sales of $500,000 or less


b)   Food and dietary retailers with annual gross sales of foods or dietary supplement products of $50,000 or less

Remember, these two exemptions do not need to be filed with the FDA. You can simply assume that you are legally exempt from FDA food label requirements.

  • Small Business Exemption #2: Must file with theFDA

These exemptions are for businesses that:

a) employ fewer than 100 full time workers

– OR –

b)   produce a product that sells fewer than 100,000 units throughout the US in a 12 month period

Remember, to obtain these exemptions from the Food, Drug and Cosmetics Act, one must file annually with the FDA.

How to Apply for an Exemption from FDA Food Labeling Rules

For smaller businesses who believe they qualify for an exemption from federal nutrition labeling laws, it is important to formally request an exemption from the FDA. To make this process easier, the FDA has an online form where you can submit your request. You can also print out and mail or fax a copy of your application for nutrition labeling exemption using this form.


Organic Label Exemption – Small Producers Don’t Need USDA Organic Certification

The strict USDA regulations on using the term “Organic” on a label allows one exemption for small producers: Producers who sell $5,000 or less worth of organic products on an annual basis are not required to become USDA organic certified.

This means that small producers of organic products may use the term “organic” on their labels. However, they cannot use the USDA certified organic seal, a third party certifier seal, and cannot make any other claims that the product is “certified organic.”

Although obtaining certification for is voluntary for these small producers, they must still follow federal standards for producing and handling of organic products. The USDA recommends that individual retail stores may want un-certified organic producers to sign a legal affidavit stating they have followed federal organic standards.


Dietary Supplements – Exemptions from Supplement Facts Labeling

Dietary supplements are exempt from 21 CFR 101.36 labeling requirements if:

  • Foods are offered for sale by a retailer who has annual gross sales of $500,000 or less and whose labels, labeling, and advertising do not provide nutrition information and do not make a health claim


Meat, Egg, and Poultry Labels –  Exemptions from Nutrition Facts Panels

The Food Safety and Inspection Service (FSIS) which regulates meat, poultry, and egg products has nutrition labels exemptions for small businesses under the Nutrition Labeling and Education Act for:

  • businesses with 500 or fewer employees
  • 100,000 pounds or less annual production of a single product, including single forms of meat such as sausage, bulk, patties, links, consumer product, etc.


*Exemptions from the New USDA Mandated Meat Nutrition Labels

Beginning on January 1, 2012 the USDA will require 40 of the most popular cuts of meat and poultry to bear individual nutrition labels. These labels are meant to provide consumers with more ready information about calories, calories from fat, etc.

This new labeling law does not apply to:

  • ground or chopped products meat processed by a single facility that producers no more than 100,000 pounds on a yearly basis
  • products intended for further processing or for intended export as long as the product does not bear additional nutritional claims beyond fat and lean percentages

The FSIS believes small business exemptions are needed because the added costs of extensive nutrition facts labeling may force them to stop production.

Although small businesses that produce ground meat products like those stated above are exempt from FSIS labeling, small businesses that produce whole cuts of meat are not exempt. “The FSIS will make point -of-purchase materials available over the Internet free of charge. Therefore, small businesses will not incur significant costs to provide nutrition information for the major cuts of single-ingredient, raw meat and poultry products.”

There you have it, a quick round-up of small business food labeling exemptions.

One last note: your company is not required to be exempt from these FDA food labeling regulations. If you plan to grow larger and have the means to establish more sophisticated food labeling practices under FDA guidelines, I encourage you to do it! QuickLabel Systems can help you get started with food label printers, labeling software, and custom printed food labels.


More Resources for Small Business Exemptions for Food Labels:

Help Developing Your New Food Label – Food Consulting Company

Honey Labeling Tips –  the National Honey Board

Food Label Printers – QuickLabel Systems

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