Did You Know? The FDA Lets Companies Decide if an Additive is Safe or Not

cyclamate packets are outlawed in the US
This is a guest blog post by Richard Perlmutter, MS.
We recently wrote about the federal Food and Drug Administration’s (FDA’s) proposal to revoke the GRAS status of partially hydrogenated oils due to their tendency to increase cardiovascular disease risk. Without GRAS status, partially hydrogenated oils will be reclassified as food additives.

GRAS is the acronym for Generally Recognized As Safe. GRAS ingredients may be incorporated in foods and beverages in a manner consistent with their intended purpose without the need to receive premarket approval from the FDA. In today’s post, we’ll contrast food additives with GRAS ingredients, and looks at the various ways the FDA has regulated, and not regulated, GRAS ingredients.

This story begins with the passage of the Food Additives Amendment of 1958. The legislation defines the term “food additive” and requires that food additives be reviewed for their safety before they can be used in food.

But the amendment also made note of the hundreds of ingredients that were already being used in foods, with no concerns about their safety − ingredients like sugar, vinegar, salt, and pepper. These ingredient were given the designation “Generally Recognized As Safe” and were exempted from safety reviews.

Along with those given a “grandfathered” GRAS status, an ingredient can also qualify as GRAS if the scientific data about its use is widely known and if there is a consensus among experts that the ingredient is safe to use as intended.

In contrast, ingredients to be approved as food additives are usually new, not well known, and often their safety determinations are based on proprietary information developed by the manufacturer of the ingredient.

Cyclamate Disrupts the Status Quo

All was well with GRAS ingredients for about ten years. Then some researchers fed a huge quantity of the artificial sweetener cyclamate (in combination with saccharin) to rodents, and found the cyclamate caused a small increase in risk for developing bladder cancer. The FDA banned the sweetener, which had been a GRAS ingredient (1). (As an aside − in many other countries the sweetener is approved and popular, including Canada, Mexico, and the United Kingdom. But the ban on cyclamates in the United States remains in effect.)

Reacting to the cyclamate scare, President Richard Nixon directed the FDA to review the safety of all GRAS ingredients. This review was an enormous undertaking and the FDA outsourced much of it to a committee of experts who were not affiliated with the FDA, the Select Committee on GRAS Substances. Over a ten years period (1972 – 1982), the committee reviewed the safety of about four hundred ingredients. Most were substances in the original GRAS list. Others were for new GRAS status ingredient submissions (2) (3).

These new submissions were designated affirmation petitions. Companies assembled all of the information they thought the FDA would need to determine if a new ingredient, and the use of that ingredient, qualified as GRAS. The FDA reviewed the submission documentation and decided to affirm or not affirm GRAS status.

Less Work for the FDA

To lessen its workload and reduce its backlog, in 1997 the FDA proposed allowing companies to determine, on their own, if ingredients and their uses qualify as GRAS. Not waiting for this new procedure to become a rule, the FDA adopted the procedure on an interim basis. As of this date which is 16 years later, the FDA continues to rely on the procedure on an interim basis to decrease its need to conduct oversight on proposed GRAS ingredients and their uses.

Companies have the option to notify the FDA and request that the Agency review their GRAS self-determinations. The FDA responds by (1) not questioning the determination; (2) indicating that it has not received enough information to accept GRAS status; or (3) agreeing to cancel the review at the notifier’s request (4).

There is a significant difference between the FDA’s former affirmations, and the FDA’s current response to notifications. In the former, the FDA reviewed the results of safety testing and agreed that an ingredient and its intended use met GRAS requirements. A “no questions to ask” letter from the FDA means the agency is not questioning the basis for the notifier’s GRAS determination. The Agency does not conduct a safety investigation, and is not specifically approving the ingredient and its use.

It’s Voluntary

A surprising aspect of the interim notification procedure is that it is voluntary. Companies can perform their own safety checks and grant GRAS status to ingredients and their uses, and not notify the FDA (5).

Self-determined GRAS status ingredients and their uses for which the FDA is notified and does not question, are listed on an FDA website. Those that the FDA does not know about are, quite obviously, not listed. Their GRAS status does not become public knowledge.

Given the potential difference in effort to self-determine GRAS status compared to submitting an ingredient for approval as a food additive, it is not surprising that most new ingredients and their uses are self-determined as GRAS. In recent years very few have been submitted as food additives.

For the period 2004 thru 2010 only 14 direct food additive petitions were submitted. In the same period the FDA was notified of 222 GRAS self-determinations (6).

A Change in Emphasis

The original intent of this post was to explain the significance of the designation of a food ingredient as an additive or as GRAS. Upon investigating the difference I learned about the weaknesses inherent with GRAS self-determinations and voluntary notifications. They may not be well known, but they need to be. Quite likely a scenario similar to the cyclamate scare of so many years ago will eventually reoccur, causing the American public to lose confidence in both the Food and Drug Administration and in the safety of food ingredients.

This concern was raised in a 2010 report by the federal government’s General Accounting Office. The report’s title − “FOOD SAFETY: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS)” (7). Very recently (November, 2013) the Pew Charitable Trust released a similar report that was the result of a three year investigation. It’s title − “Fixing the Oversight of Chemicals Added to Our Food” (8).

Hopefully the FDA will take notice, and begin doing again what most Americans don’t realize it is not doing, which is evaluating all new food ingredients for their safety when used as intended.

 

REFERENCES:

  1. Cyclamate on Wikipedia
  2. FDA’s Approach to the GRAS Provision: A History of Processes
  3. History of GRAS List and SCOGS Reviews
  4. How U.S. FDA’s GRAS Notification Program Works
  5. Guidance for Industry: Frequently Asked Questions About GRAS
  6. Neltner TG et al., Navigating the US Food Additive Regulatory Program Comprehensive Reviews of Food Science and Food Safety 10(6):342-368, November, 2011
  7. FOOD SAFETY: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized As Safe (GRAS)
  8. Fixing the Oversight of Chemicals Added to Our Food

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  • rubicon bill

    It shows the importance of checking for ourselves (with Fooducate). I wonder for all FDA is not doing, how many employees do they have and what do they do all day?

  • http://www.supermom101.com/ SuperMom101

    Terrific post! Any chance you can provide a link to those food and beverage “ingredients” listed as Generally Recognized as Safe (GRAS). Can’t seem to locate one and am now very. . . very curious about those “food ingredients” that were more likely to have been “grown” in a chemistry lab than on a field.

    Best health always.

  • Mike Benninger

    I find it curious how in the USA it’s fine to use GRAS and almost no one questions the Monsanto/Kellogg/General Mills/Pepsi’s of the world, but Europe uses the “proven safe” method and we never hear about that being adopted here…makes you wonder who is really in charge huh ?

  • timlockk

    Excellent post. It’s a shame that more people won’t see this.

  • timlockk

    To expand on this topic, let’s quickly discuss what is happening with GMOs, specifically those engineered to produce the Bt toxin.

    Under FDA law, any novel substance added to a food must be thoroughly tested, unless it is defined as GRAS. New proteins engineered into foods (in this case the Bt protein) are regarded as additives. However, since the companies can determine whether their new protein is GRAS or not, they all obviously say it is, and voila! No safety studies needed.

    Another legal loophole the FDA exploited was the fact that since the Bt protein is a pesticide, it is exempt from FDA regulation and instead would fall under the jurisdiction of the EPA.

    Crazy, right?