Petitions, Checklists and Headaches

Petition Granted

Earlier this month, FDA granted a partial petition to not allow the following synthetic flavor substances in food. In parentheses are the flavors I remember using them in.

  1. beta Myrcene ( mango, orange, mint)
  2. Methyl Eugenol (raspberry)
  3. Ethyl acrylate (rum and egg nog)
  4. Pulegone (mint)
  5. Pyridine
  6. Benzophenone

Checklists

These substances are on customer’s “checklists”. Checklists are disclosures food manufacturers need from ingredient suppliers before they buy flavors. They are helpful communication tools. Usually, there is a column for the flavor developer to disclose the amount added and another column for disclosing the amount present. The amount present is how much is added as part of an ingredient (such as a natural essential oil).

The recent ban on synthetic flavor substances does not affect the use of these ingredients as they are found naturally, just as they are added. For example, myrcene is a natural component of orange oil and is ok to use as such.

Checklists are a headache, but also a very important process for delivering safe and desirable flavors to the marketplace.

The six chemicals that FDA had to ban are chemicals that are often found on these “checklists”. Checklist substances could be restricted by the Drug Enforcement Administration (DEA), European Food Safety Authority or California Prop 65. 

The Headache

Congress has established the Food and Drug Administration (FDA) to be the agency that enforces the Federal Food Drug and Cosmetic Act (FFDCA). FFDCA houses the Food Additive Amendment which has the Delaney Clause.

The Delaney Clause specifically prohibits food additives that cause cancer in humans or animals from entering our food supply. It is a very rigid law that has a 40 year history of controversy  primarily because safety is defined in the law, not by FDA review.

Based on the Federal Register notice, it is clear FDA’s decision to ban these synthetic flavor substances was not based on risk of human harm. FDA specifically points out that their discretion to determine the safety of food additives is limited by the Delaney clause.

The Delaney clause has been held up in court several times and the cases are mentioned to in the recent Federal Register announcement:

FDA granted the petition to ban these flavor ingredients because of a legal action taken by eleven non-government organizations. The legal action was for FDA to enforce the food additive amendment and Delaney Clause. The Flavor Extracts Manufacturers Association (FEMA) initially responded to this ban by reiterating that Delaney is outdated and needs to be revoked.

Questions

This 40 year stalemate between science, law and emotions begs further questions.

  • Is our food supply really safe?  For everyone?  Academy of Pediatrics recently stated that changes in food additive laws are necessary to assure the safety of infants and children.
  • Are concerns about the GRAS process (an exemption to the Food Additive Amendment) linked to this petition?
  • Did concerns about non-flavor food additives (packaging material, colors, dietary substance, food contact material) drive this petition on flavor ingredients? FDA specifically banned benzophenone as a both a flavor ingredient and a food contact material.
  • Are there concerns that food additives are not being used according to guidelines (amount or food type) and therefore unsafe?

Or am I just asking for more headaches?

 

*Further information flavor substances and the GRAS process can be found in a recent article in Perfumer and Flavorist Magazine?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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