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Food Ingredients: Many Routes to Safety Approval

The Nutrition Facts label can be the conscious consumer’s best friend, but it often leaves shoppers more confused than informed.

It may be comforting for someone to find a list of common and easily recognized ingredients on the label. For instance, Triscuits crackers were named and marketed for only including three ingredients: whole wheat, oil, and salt.

But the simplicity of the Triscuit has become less the norm and more of an anomaly on grocery shelves. Cinnamon Burst Cheerios, for instance, have 16 ingredients, most prominently featuring corn in various forms. The list includes: whole grain corn, sugar, corn bran, corn meal, soluble corn fiber, canola and/or rice bran oil, whole grain oats, brown sugar syrup, salt, cinnamon, guar gum, natural flavor, color added, vitamin E (mixed tocopherols), and BHT added to preserve freshness, followed by a list of vitamins and minerals.

The recently bankrupt Hostess’s Twinkie was famous for having 37 ingredients, including several powder-based chemicals and the vague “natural and artificial flavors.”

If the inquisitive shopper doesn’t understand what a specific ingredient is, how it is made, or what its purpose is, can they rely on the industry’s good will or the government’s regulatory authority for solace that every ingredient on a label is safe for consumption?

The U.S. Food and Drug Administration has authority over all substances used in food. Following the adoption of the Food Additives Amendment in 1958, an ingredient must be reviewed by FDA before being accepted as an approved additive.

But there is another way an ingredient can be used in food without being an FDA-approved additive, and that is if it is “Generally Recognized as Safe (GRAS).” Ingredients that were widely used and shown to be safe before the 1958 amendment automatically fall into this category. Examples include salt, baking powder, flour or water.

There are two ways in which a new ingredient can receive GRAS approval:

1) A company can utilize expert scientific opinions to conclude that an ingredient is GRAS. The company does not have to provide information to either the FDA or consumers regarding that determination.

2) Alternatively, a manufacturer may issue a “GRAS notification” to FDA, providing the scientific support for the specific ingredient. FDA will respond by issuing a letter that either does not question the offered research or rejects the notification. An ingredient manufacturer who wishes to market its product to different food companies may choose this route in order to publicize the availability of the new ingredient. If the company requests that FDA cease its evaluation of a GRAS notification at any time, the agency will do so.

The statutory requirements are the same for options 1 and 2, but self-affirmation gives the company the option of simply relying on a trained scientific safety recognition before selling an ingredient.

In 1997, FDA stopped using a process where FDA would make GRAS affirmations, and first gave food manufacturers the opportunity to use the “GRAS Notification” process. According to Tom Neltner, project director for Pew’s Food Additives Project, this development resulted in a noticeable increase the following year in ingredient information made available to FDA.

“If you look at it, the numbers went way up in 1998,” Neltner said in an interview with Food Safety News. “That suggests that companies that used self affirmation without ever notifying FDA started notifying FDA.

“The GRAS notifications bring in more information and allow FDA to see things they never would have been notified about before.”

Neltner added that while the notification system led to companies more freely providing information to FDA, it also cut back on the public’s involvement in food regulation. A food additive petition includes a step where FDA must correspond with the public through a regulatory procedure called “notice and comment” rule making.

“Obviously we also note that if you use a notification, while it may be administratively more streamlined, it does cut the public out of the loop,” Neltner said. “The notice and comment is taken away and [FDA’s] requirement to respond to comments is gone, so you don’t get the input of academics; you don’t get the input of competitors; you don’t get the input of the public on these issues. And that’s a drawback.”

Even with the influx of notifications since 1998, FDA still may be unaware of ingredients due to the voluntary nature of the GRAS self-determination option that companies may utilize.

In order for a food manufacturer to self-determine that an ingredient is GRAS, it must comply with the same standard that a food additive must meet, meaning that it must “be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food.”

“You have to actually be qualified to understand the field,” Neltner said. “But you don’t have to have a scientific panel look at it. The law does not prohibit a company employee from making a determination of safety. The only thing the FDA insists on is that there be published studies.”

Marianna Naum, in the Office of the Deputy Commissioner for Foods and Veterinary Medicine, said that the flexibility of GRAS self-determination helps the food industry.

“The advantage of having that, as the manufacturer, you don’t have to wait on the agency to render a decision,” Naum said in an interview with Food Safety News. “It’s a more expedited process.”

A company has no requirement to contact FDA when they make a GRAS self-determination. Does that mean FDA is unaware of a lot of the chemical ingredients being used in food today?

“There aren’t a lot of ingredients that FDA is unaware of,” Naum said. “Since you’re talking about general recognition of safety, you have to be talking about familiarity with the ingredient in the scientific community. I do think it is important for us to keep in mind that these ingredients aren’t necessarily new ingredients. We are just finding a new use for it. I think it is a misconception of the GRAS program. These are mostly old ingredients used in new ways.”

Referring to the self-determination system, Pew figures that there are a large number of new ingredients that have never been reviewed by FDA.

“We estimated that there were 1000 chemicals that were self affirmed as GRAS and never reviewed by FDA,” Neltner said. “It could be as low as 500. It could be as much as 2000. But we think there are 1000 new chemicals that the FDA has never reviewed.”

Once a company has made a self determination of GRAS, or it has notified FDA of its GRAS substance, the ingredient is free to enter the market. At that point, what would it take for FDA to come to a different conclusion? How many consumer complaints would it take for FDA to do their own research or even ban the substance?

Naum said FDA doesn’t have a set system for reviewing GRAS ingredients. “If there is a substantiated reason [for further testing], yes we would,” Naum said. “There has to be some reason for us to do that. If a company makes a self determination of GRAS, it means there’s a scientific body behind them that supports that decision.”

Naum added that FDA can review a particular ingredient at any point, and for any reason.

“That can really vary on a case by case basis,” Naum said. “In a sense, it’s good that there’s no set criteria because it allows for flexibility for the agency. Right now that there is no set criteria for a minimum level of questioning gives the agency more flexibility. It can take one case. It can take 10 cases.”

Neltner said a reassessment system might lead to more rigorous review of GRAS ingredients.

“There is no systematic reassessment of chemicals,” Neltner said. “Pesticides have to get reviewed for safety by the EPA every 15 years. They just went through a massive review of over-the-counter drugs at FDA.”

“Without a system it’s hard to set priorities. Without a system, you are relying on citizens petitions. So without a system to deal with it, it’s often very hard to change the status of a chemical.”

Pew estimates that there are more than 10,000 ingredients allowed under FDA’s food additive and GRAS regulatory structure, with 49 percent of those being approved through the food additive petition process and 43 percent coming in as GRAS.

Those numbers might be hard to comprehend for someone walking the aisles of his or her local grocery. Neltner says it’s not easy for FDA to work in that environment either.

“These are very complicated issues, Neltner said. “The law hasn’t been revised in the last 50 years. … And [FDA] is an office that keeps getting more and more work on them.”

 

© Food Safety News
  • Mike_Mychajlonka_PhD

     I think this article could benefit from more of a
    toxicological perspective, especially if “safety” is being defined as the
    absence of toxicity.  This article
    talks about the safety status (i.e.,
    GRAS or food additive) of each ingredient in a food product without
    consideration of how mixing such ingredients may impact (positively or
    negatively) the safety of that final product.  Lastly, this article, quite correctly, makes the point that
    an ingredient may be a pure chemical compound or an enormously complex
    botanical “ingredient,” whose “safety” is presumed to be sum of its parts.  A purified compound from another source
    may reasonably be expected to show the same toxicity as the original, but how
    can the same be said of complex botanicals?  Keeping track of ingredient GRAS presumes that all
    ingredients are stable and reproducible. 
    Yet, how can one say that a complex botanical obtained from a given
    supplier this month is the same or different than the same ingredient obtained
    a year ago last April, whose safety was evaluated?  You cannot, as the saying goes, cross the same river
    twice.  If not, then why
    concentrate on the safety of ingredients at all?  Certain kinds of toxicological testing, such as that based
    upon the Zebrafish embryo, are both rapid and relatively inexpensive.  Does it not therefore make sense for
    all concerned (consumer, manufacturer and regulator) to leave alone the
    question of the safety of ingredients we have trouble defining anyway and instead
    concentrate on the GRAS status of a given formulation (not individual lots) of
    the final product?  I can see where
    this approach might at least provide some protection to food manufacturers,
    especially those who find their product category under fire (e.g., energy drinks). 

  • Oginikwe

    Bring  back the Delaney Clause.