A loophole in the FDA's process for evaluating food ingredients—paired with vague ingredient labels and lax oversight—means hardly anyone knows exactly what we're eating. Learn more about our latest analysis of how food and flavor manufacturers hide thousands of food chemicals, some of which have been deemed unsafe in other countries, from consumers and the FDA.

The problems with ‘flavor’ and ‘spices’

The way food tastes and smells is important in choosing what we eat. Food companies engineer foods to ensure they taste and smell appealing by adding flavors and spices. These can be natural substances or chemicals synthesized in a laboratory. They can be a single ingredient—like vanilla extract, dried basil, or a specific chemical—or blends of many ingredients formulated and developed by professional flavorists.

One thing all spices and flavors have in common is that food companies do not actually have to tell consumers which of these substances they have added to a food or beverage. Almost all other food ingredients must be explicitly identified by name in the ingredient list found on food packages. However, federal regulations allow the food industry to use the vague catchall terms “artificial flavor,” “natural flavor,” and “spices” instead of identifying each individual flavor substance by name.

Last year, CSPI released a report that explored the problems that arise when companies hide ingredients behind these terms. In that report, we called for reform to protect consumers from dangerous chemicals, allergens, and unwanted animal products in foods and beverages. Since then, CSPI has continued to investigate flavor safety, and we have identified more flavor substances that are banned or restricted in the European Union (EU) due to safety concerns. We have updated our report with our new analysis of those flavors.

Read the full report

“Generally recognized as safe:” A legal loophole exploited by the flavor industry

Food and flavor companies leverage a legal loophole that allows anyone, including companies themselves or industry-paid experts, to declare that a substance is “generally recognized as safe,” or GRAS, and in effect bypass FDA approval for new food chemicals (we call this the “GRAS loophole”). Worse yet, food companies do not even have to notify the FDA of their GRAS determinations before or after adding the substances to our foods (we call this pathway within the GRAS loophole “secret GRAS”).

The GRAS loophole is widely exploited by the flavor industry, especially the industry trade group called the Flavor and Extract Manufacturer Association (FEMA). FEMA pays a group of scientists to serve on its “GRAS panel,” and member companies of FEMA—which include flavor manufacturers, food companies, and even tobacco companies—can then have the FEMA panel conduct an evaluation to determine if a substance is GRAS. FEMA’s panel has declared nearly 3,000 substances GRAS over the past six decades.

As a result of the flavor industry’s rampant exploitation of the GRAS loophole, thousands of flavor substances are currently in use that have never been formally deemed safe and approved by the FDA. Because companies can hide these substances behind the terms “natural flavor,” “artificial flavor,” or “spices,” not even the FDA knows which substances have been added to our foods and whether they are truly safe. Only industry has determined that those chemicals are safe, which is a clear and troubling conflict of interest because food and chemical companies want to make money selling those chemicals and the foods in which they would be used. Flavor and food companies closely guard their flavor blends as “trade secrets” to prevent competitors from making copycats of their popular foods. Those companies choose to protect their bottom line at the expense of transparency and public health. In practice, flavor and food companies are the ones deciding whether flavor chemicals are safe, not the FDA.

US flavor industry encourages use of unsafe flavors banned in the EU

Unlike in the US, there is no GRAS loophole in the EU. Companies must get formal approval from regulators before adding new flavors to foods and beverages.

In the EU, the term “flavouring substances” refers to flavors that are specific, defined chemicals, like vanillin, while the term “flavouring preparations” refers to substances derived from vegetable, animal or microbial origin, like vanilla extract, which are not specific chemicals but rather mixtures of many chemicals. “Flavouring preparations” do not need to be approved if they are produced from food, but “flavouring preparations” not derived from foods, as well as “flavouring substances,” must be evaluated and approved. This means that vanillin, but not vanilla extract, had to be approved before use in the EU.

The EU maintains a publicly available list of approved “flavouring substances,” although it does not include “flavouring preparations” or smoke flavors. If a substance is absent from that list or removed from it, food companies can’t add it to foods sold in the EU (effectively those substances are banned). In the original publication of our report, we listed several flavors banned in the EU but allowed in the US. Since then, we continued our review of EU flavor regulations to identify more examples of flavors that may be present in foods in the US and pose health concerns. In our updated report, we added a new section highlighting eleven substances deemed GRAS by FEMA in the US that have been banned or restricted in the EU due to safety concerns raised by the European Food Safety Authority (EFSA).

Ten of those substances, listed in the table below, were removed from the EU list of approved flavors over concern that they could cause genotoxicity, or DNA damage. Genotoxicity is one possible way chemicals can cause cancer and other adverse health outcomes.

_{* A single substance might be called different names by the FDA, EFSA, FEMA, and others. When they differ, we list the names used by the FDA and EFSA. We also include CAS numbers to further identify these substances. CAS numbers are unique identifiers for chemical substances that are widely used globally for the purpose of chemical identification. A substance may have multiple CAS numbers; we list each of the CAS numbers used by the FDA, the EU, and FEMA for each substance. FEMA numbers are also useful identifiers. See footnote below for additional information about FEMA numbers.}

_{† Each of these substances still have entries in the EU Flavourings Database. This does not mean that they are legal to use. Each of the respective entries in that database for these substances (except 4-methyl-2-phenylpent-2-enal) states that these are not permitted in foods in the EU. The entry for 4-methyl-2-phenylpent-2-enal has evidently not yet been updated to reflect the decision to remove it from the list.}

_{♦ This symbol denotes substances that are known to occur naturally in foods. These substances can therefore be listed on food ingredient labels as “natural flavors” if they are derived from natural sources. Some of these are, or may, also be produced synthetically, meaning they could also be hidden in ingredient lists as “artificial flavor.” Myrtenyl formate and delta-damascone are not reported to occur naturally in foods, suggesting they are exclusively artificial flavors.}

_{⁑ As noted in Chapter 1 of CSPI’s flavor report, the FDA maintains a Substances Added to Food Database, which includes substances deemed GRAS by FEMA. Listing in this database is not an indication that a substance is approved by the FDA; it merely indicates that the FDA is aware that the substance is used in foods. Substances formally approved by the FDA are listed in FDA regulations as well as this database. Each of the substances in this table is listed in the FDA database, but only one (perillaldehyde) has been formally approved as a food additive by the FDA. Because FDA approval is not required for flavors in the US due to the GRAS loophole, the substances listed as “not FDA-approved” are allowed in food in the US.}

_{‡ FEMA assigns unique numbers to flavors its panel has deemed GRAS. Those numbers are listed here for reference. FEMA also maintains a flavor library, which is a database of substances it has deemed GRAS. References included in this table refer to specific entries in that library.}

_{** FEMA considers alpha-damascone and cis-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)but-2-en-1-one to be synonymous, as indicated by the fact that it lists the CAS numbers for both to a single entry in its flavor library (meaning only one FEMA number is assigned), but the EU regulates them as distinct chemicals. We have included each as a separate entry in this table because the EU considers them distinct.}

The eleventh substance we uncovered in our updated investigation is 2,4-hexadienal, which is restricted, but not banned, in the EU. It was classified by the International Agency for Research on Cancer (IARC) as possibly carcinogenic to humans in 2012, and there was concern that it caused cancer through genotoxicity. The EU limited the use of 2,4-hexadienal in 2017, although later evaluation by the European Safety Authority concluded that newer information ruled out concerns for genotoxicity—just the first step in the safety evaluation process. It remains to be seen if and how IARC will interpret the new genotoxicity data and what EFSA will conclude after completing its full safety evaluation. Regardless, federal laws in the US expressly prohibit a food additive from being deemed safe if it causes cancer in animals or humans. FEMA abused the GRAS loophole to market a chemical that Congress intended to be illegal.

Since 2,4-hexadienal occurs naturally in some foods in addition to being produced synthetically, it can be hidden in ingredient lists as “natural flavor” or “artificial flavor” in US foods, depending on whether it was naturally derived or manufactured, keeping consumers in the dark.

How you can help: Sign our petition for safer food

Current federal regulations allow companies to bypass FDA approval for new food additives by simply declaring that the substance is GRAS. As a result, industry—not the FDA—decides which chemicals are safe for us to eat, and there are now thousands of chemicals added to our foods that have never undergone independent safety evaluations by the FDA.

Sign the petition to demand the FDA—not the food industry—decide what's safe for our food.

Read the full report