Trim the fat, cut the GRAS?

August, 2015

Eric F. Greenberg Attorney-at-Law

Use it or lose it, goes the old saying. But what happens if you do use it? Why, it makes you want to use it again, of course.

FDA has finalized its withdrawal of Generally Recognized As Safe status for partially hydrogenated oils (PHOs). That's a big deal, potentially, for other substances in food, and here's why: FDA doesn't remove uses of substances from GRAS status very much. It's been decades since they last did so.

FDA has taken various actions relating to GRAS status of substances, but to find anything even arguably similar to this kind of reversal you have to look back to the 1980s when they un-GRAS'd some uses of sulfiting agents, or the 1970s when they took similar action against substances like cyclamates, saccharin and brominated vegetable oil.

Now that FDA has started using these specialized regulatory muscles again after a long lay-off, it might be easier to give them another workout, turning their attention to uses of other substances.

GRAS is a status bestowed on substances that are added to or otherwise get into food, including packaging materials. GRAS status reflects a consensus among relevant scientists that the particular dietary exposure to the substance is both safe and, no surprise, generally recognized as such. If new science emerges to cast doubt on what had been a widespread conclusion that a use is safe, then that use loses its GRAS status.

What FDA did here, specifically, is announce that it no longer thinks relevant scientists agree that PHOs are Generally Recognized As Safe, therefore manufacturers cannot add them to food on that legal basis. FDA said that based on a variety of types of scientific information, it had concluded that PHOs are not GRAS "for any use in human food." FDA set a generous compliance date: 3 years from now, or June 18, 2018.

If manufacturers want to use PHOs in the future, they will have to get their individual use cleared by FDA as a food additive. And to do that, they'll have to prove the substance is safe when used that way.

We looked at these issues previously, after FDA announced its proposal to take this action (pwgo.to/1692). As required by federal law, FDA announced its final decision in the June 17, 2015 Federal Register, together with explanations of its reasoning and responses to the comments it had received from the public on the proposal, which numbered over 6,000.

When it published its final decision, FDA said that it had concluded that qualified experts no longer believe that PHOs, the main way people get trans fatty acids in their diets, are GRAS, because they instead think that trans fats contribute to the risk of coronary heart disease, at essentially any level of intake. FDA says, "all refined edible oils contain some trans fat as an unintentional byproduct of their manufacturing process; however...trans fats are an integral component of PHOs and are purposely produced in these oils to affect the properties of the oils and the characteristics of the food to which they are added. In addition, the trans fat content of the PHOs is significantly greater than the amount in other edible oils."

What is the next target for potential GRAS withdrawal, if FDA decides to pursue this path again? Salt, perhaps, or caffeine, though there are important differences between them and PHOs. For one thing, it's clear some intake of salt is beneficial, and caffeine almost certainly is safe at some levels, while FDA says there's no consensus that any particular low-level intake of PHOs is good for you. Still, some of the uses of each substance could be targeted for a formal finding that they are no longer GRAS.

All this comes against the backdrop of increasing public controversy over the regulatory handling of GRAS uses of substances in and around food. Which is to say, for maybe the first time ever, there is some controversy about it, as consumer advocacy groups have tried to raise issues about the transparency of company and FDA decision-making when GRAS conclusions are reached, as well as conflict of interest and other issues. One result of the pressure has been that the Grocery Manufacturers Association, representing many food makers, has said it will take steps to add transparency about its members' decisions that their use of substances is GRAS.

And GMA is also jumping right in to win back approval for some uses of PHOs, preparing to submit a Food Additive Petition to FDA about "low level uses" that it says it will establish are "as safe as the naturally occurring trans fat present in the normal diet." They add that "Food and beverage companies have already voluntarily lowered the amount of trans fat added to food products by more than 86 percent and will continue lowering PHO use in foods."

So the story of PHOs promises to have a few more chapters ahead, as might the broader story of FDA efforts to undo the GRAS status of some uses of some substances. PW Eric Greenberg can be reached at greenberg@efg-law.com, or visit his firm's Web site at www.ericfgreenbergpc.com.

This article is informational only and is not intended as, and should not be considered to be, legal advice.

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