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Learn the difference between Food Additives and Food Ingredients

4 Steps to avoiding FDA and USDA regulatory headaches and fines


Jump in without looking. Too many food entrepreneurs get an idea and execute it without spending even a modicum of research to make sure the idea is a real opportunity. food and nutrition information is required on your nutrition food label. When a brand is making food health claims, you have to take some extra steps to avoid FDA and USDA regulatory headaches.

Food Health Claims

If you have a food and beverage product that is making certain claims, you should also research the FDA and USDA sites to insure you won't get into trouble. There are several levels of Food Health Claims at the FDA and it is worth your effort to read the article and further explore what you can and can't say.

The worst result of not knowing what you are claiming is getting a cease and desist order. What's that? It is a letter from either the USDA or FDA that says you are violating a regulation to the point where you must immediately stop producing and distributing your product.

A Case Study - Perky Jerky Beef Jerky

<Perky Jerky developed caffeine infused beef jerky using an ingredient called Guarana. Guarana is native to the Amazon rain forest and has twice the amount of caffeine as coffee beans. The USDA issued a cease and desist order claiming Perky Jerky was violating the food additive status of Gurana. Guarana is authorized as a food additive, meaning small quantities, as a flavoring vs. larger quantities, which would be an ingredient, to produce a caffeinated boost.

What is the USDA Saying Here and How Can I Learn More about Food Additives vs. Food Ingredients?

It is actually very easy so here are step by step examples of identifying food additives vs. food ingredients.

Listing of Food Additive Status Part I section

Look up the ingredient, in this case Guarana

It will return something looking like this

  • Guarana - FL/ADJ, REG, GMP, In conjunction w/flavors -172.510

Read the codes and the accompanying explanation

  • FL/ADJ Substance used in conjunction with flavors.
  • GMP In accordance with good manufacturing practices; or sufficient for purpose; or quantity not greater than required.
  • REG Food additives for which a petition has been filed and a regulation issued.

STOP! The above indicates a yellow flag since it is confusing. So look further.

Look at the code GRS and find the explanation

Generally recognized as safe. Substances in this category are by definition, under Sec. 201(s) of the FD&C Act, not food additives. Most GRAS substances have no quantitative restrictions as to use, although their use must conform to good manufacturing practices. Some GRAS substances, such as sodium benzoate, do have a quantitative limit for use in foods.

Ingredients are GRAS

Guarana is not GRAS. I am not an FDA food attorney but there is enough here to suggest it can't be used as an ingredient and a food entrepreneur considering a new product development of a food and beverage brand needs to do some further research here before attempting a costly new product launch.

Food Entrepreneurship Tips. Tips for helping the entrepreneur how to start a food business.

New Product Development - Do some research please! The above took me all of 20 minutes. If you are confused… do more research. If you still are confused, retain the services of a food laboratory of find one of the University Extensions like Rugters Center for Advanced Food Technology to get an answer.

New Product Launch - Don't launch until you have completed the step above. That simple.

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