Eating “Healthy” – What do ‘Organic,’ ‘GMO-free,’ ‘Vegan,’ and ‘Gluten-Free’ really mean, and who makes the rules?

By John H. Barkley, Esq. SHUSTAK REYNOLDS & PARTNERS, P.C. July 2014       

Americans are becoming more conscious of where their food comes from each passing day. Just recently, in Prop 37, California voters considered requiring labels on food that contained genetically engineered organisms.

Today Organic, GMO-free, Gluten-free, and other ingredient-sensitive terms have joined vegetarianism and veganism as popular lifestyle choices (except for Gluten-free, which is also associated with people suffering from Celiac disease). What do these titles mean? Are labels on food to be trusted? Who makes the rules? This article will provide an overview of each, and hopefully point the reader to primary sources of information and law.


Out of the four (4) terms discussed in this article “Organic” has the most government regulation. Organic foods, in general, are those grown without pesticides, herbicides, or chemical food additives. The term ‘Organic’ therefore generally describes the manner in which the foods are produced as well as specific ingredients in the food.

Regulation of Organic Food. Regulations issued by the U.S. Department of Agriculture (USDA) set standards for someone to label food as ‘Organic.’ In fact food must go through a certification process, and there are three levels of ‘Organic’ foods recognized by the USDA.

a. “100% Organic” – If the food is labeled “100% Organic,” then all of the ingredients must also be certified organic, and any processing of the food must meet USDA qualifications to be organic.

b. “Organic” – If the food is labeled “Organic” then at least 95% of the ingredients must also be certified organic, and the non-organic ingredients must be among those allowed in the USDA’s “National List.”

c. “Made with” category – The lowest level is the “made with organic ingredients” label, which requires that at least 70% of the ingredients be certified organic. The non-organic ingredients must be among those allowed in the USDA National List.

Certification Process for Organic Foods. Before someone can label food as “100% Organic,” “Organic,” or “Made with Organic ingredients” the food (and the way it is produced) must be certified under those categories. The USDA lays out a process for certification and uses certifying agents to administer the certification process. A list of authorized certifying agents is available on the USDA website.

Prohibited Ingredients and Substances for Production of Organic Food. For the second and third tier of organic foods, the non-organic ingredients must both a) be on the National List which is shown in 7 C.F.R. 205.605; and b) cannot be made using Excluded Methods, defined in 7 C.F.R. 205.2.

For all three tiers of organic foods, the certified organic ingredients (and the end-product being labeled as Organic) must be produced using only the chemicals or ingredients listed in 7 C.F.R. § § 205.601, 205.603, 205.606, (the “approved list”) and they may not be produced using the chemicals or ingredients listed in 7 C.F.R. 205.602, 7 C.F.R. 205.604 (the “prohibited list”). See 7. C.F.R. 205.105. The lists are too long to reproduce here. However if the reader has read those lists it was probably obvious that the “allowed” list does still allow for many chemicals (including the likes of newspaper-generated mulch as a herbicide, lime, and chlorine) to be used in connection with the food production process. For the more toxic materials, there are restrictions in place that prohibit contact between the “allowed” material and the organic food, and much of the “allowed” chemicals and substances are used to clean equipment or as alternatives to spraying crops with pesticides or herbicides.

Leading into the next category, it is significant to note that “Excluded Methods,” as defined in 7 C.F.R. § 205.2 specifically includes genetic modification of organisms and lists about half-dozen varieties of genetic engineering processes common in modern agriculture.


Genetically Modified Organisms are living things which have been created or altered though modern genetic engineering.

Regulation of GMOs. Unlike with the “Organic” term, the regulation of GMOs, at the Federal level, happens in eight agencies which fall under either the USDA, FDA, or the EPA (and the ATF in connection with alcoholic items), depending on the type and use of the GMO.

Federal laws and regulations govern the production, transportation, labeling of GMOs in general (which may be used not only for human food, but in medications, animal fee, and production of cosmetics and industrial chemicals).

When it comes to food for human consumption, the key agencies are the Center for Food Safety and Applied Nutrition (falling under the FDA), and the Food Safety and Inspection Service (falling under the USDA). Most of the GMO regulation covers the processes used to make GMOs to be used in producing food, along with rules to protect against the release of GMOs which pose a threat to food crops.

GMO labeling and the FDA. For human foods regulated by the FDA, producers are generally discouraged from using a label such as “GMO-free” or “non-GMO” as the FDA has issued guidance that such labels are most-likely misleading for a variety of reasons. See Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Draft Guidance, 66 FR 4839. Ever since 2001 when this guidance was issued, the FDA has essentially stood its ground. So while labeling food as “GMO-free” is not specifically prohibited, it is generally a no-no to label food regulated by the FDA as GMO-free. It should be noted that food thaat is certified as “Organic” under USDA guidelines is prohibited from containing GMO.


Until recently, the only labeling requirement imposed by the FDA on foods claiming to be “Gluten-Free” was the blanket requirement that food labels must not be “misleading.”

However, in August, 2013 the FDA added 21 C.F.R. Part 101391 to address gluten-free food labeling. The rule states that when a food label contains the words “Gluten-Free,” “Non-Gluten,” or similar labels, the food must contain less than 20 ppm (parts per million) of gluten. It goes on to state that if any of the listed ingredients are wheat, or is labeled “contains wheat”, the label must also state that “[t]he wheat has been processed to allow this food to meet the [FDA] requirements for gluten-free foods.”

Consumers should still be aware that, since this regulation was enacted nearly a decade after public awareness of Gluten-Free foods began to rise, many sources claiming to have Gluten-Free food may not be aware of the regulation and therefore may or may not be in compliance.

Vegan labeling isn’t specifically regulated by the FDA. Since the USDA regulates meat, dairy, and egg products, we aren’t likely to see any regulation of the term by the USDA anytime soon either.

However, producers of Vegan foods are still prohibited from using labels that are not misleading. This leaves producers in a somewhat difficult situation when labeling their foods as Vegan, since the term is still defined by an amorphous public perception or belief as to the meaning of the word. A good approach for producers may be to obtain certification by independent groups, such as Vegan Action, the American Vegetarian Association (which certifies both vegetarian and vegan foods separately), or the Vegan Society (UK). Going through the certification process serves both the producer and the consumer in making sure the consumer knows exactly what they are or are not eating.

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