Why must FDA make its own job on food additives so hard?

Let’s face it: we all make self-destructive choices from time to time.  But when federal regulators illogically shoot themselves in the foot, the harm to public safety can be serious.  Such is the sad situation at the Food and Drug Administration, which just can’t seem to get it right when it comes to the regulation of food additives.  

For years, FDA has bemoaned the alleged limits on its authority to meaningfully oversee the safety of food additives.  But in 1958, Congress had a different vision.  After several years of hearings and reports investigating the risks to consumers from dangerous food additives, it enacted the Food Additives Amendment, which directed FDA to “protect the health of consumers by requiring manufacturers of food additives and food processors to pretest any potentially unsafe substances which are to be added to foods.” 

{mosads}At the time, Congress sensibly wanted to set up a system that permitted substances that clearly were safe – like vinegar – to be used without pretesting.  So it allowed any substance that was “generally recognized as safe,” or “GRAS,” to remain outside the regulations for food additives, which required a petition and review process by FDA before being used.  Fast forward to 2015, and it is clear the GRAS provision has swallowed the law: now virtually all new substances slip quietly into our food supply through the GRAS exception, allowing them to sidestep the food additive approval process altogether.  In 2014, only one food additive petition was submitted to FDA, while an estimated thousands of GRAS chemicals are currently used in food without any FDA notice or review.   

You would think that regulators would want to get a handle on this unpatrolled marketplace and its risks for public health.  And some likely do.  But others at FDA have evidently been drinking Kool-Aid from the food industry.  Susan Mayne, the new director of FDA’s Center for Food Safety and Applied Nutrition, remarked at a recent meeting of food lawyers that “FDA cannot force companies to submit GRAS notifications for new or expanded uses of a substance” because “that authority would require a change to the law.” 

Mayne’s comments echo FDA’s longstanding view that it lacks sufficient legal authority to require notice of GRAS determinations by companies.  The problem is that this view is pathetically, obviously wrong.  It doesn’t do the agency any good, either.  

As we told FDA in a lengthy filing in April, the FDA is not only allowed to require companies to tell them everything that is being used in the food supply, it is actually required to do so under the 1958 law by the operation and design of the statute.  The basic reason is simple: for FDA to assure the safety of the food supply, it actually has to know what’s in our food.  

Today, companies can tell FDA about their GRAS determinations, but face no requirement to do so.  Yet Congress’s goals in assigning that important responsibility to the agency can only be achieved if FDA is able to police the line between GRAS substances and those that do need approval as food additives.  It should be obvious, but the agency cannot do this critical task when GRAS determinations can be made by industry in secret, without any notice to FDA.   

Moreover, as FDA well knows, companies regularly make GRAS determinations for substances that are really food additives – including substances that have no proven record of safety or were flagged as a carcinogen by reputable scientific bodies like the International Agency for Research on Cancer.  Without required notifications, FDA cannot ensure that “food additives” are pretested for safety as Congress plainly intended. 

The agency’s view of the limits on its power wrongly conflates independent determinations by industry with secret ones, yet nothing in the law indicates Congress intended these decisions to be secret.  To the contrary, the legislative history is clear that Congress wanted food additive petitions to be the only mechanism for approving novel substances.  It also envisioned that FDA would conduct active and ongoing reassessments of the safety of substances in light of evolving scientific understanding of risks to human health.  Secrecy is anathema to both goals. 

The law also reasonably requires that the agency and companies – both for GRAS substances and for additives – calculate the cumulative effects of a substance, taking into account other “chemically” or “pharmacologically” similar substances.  No one – not the agency, industry or public health organizations – can do that if GRAS determinations stay in the dark.

Obtaining notice of industry’s decisions on GRAS is essential for the agency to do a decent job and is therefore permitted under the agency’s existing authority.  A distinct provision in federal law gives FDA authority to issue rules for the “efficient enforcement” of the statute.  Even if the industry were to challenge this authority in court, courts evaluate whether an agency is proposing an efficient means to achieve a statutory goal.  Mandatory notification obviously provides by far the most efficient way to obtain the critical information that is needed to make the whole system work.  

FDA should be embarrassed by its repeated, unfounded assertion that it is helpless to require notice of what is in the food supply.  The odd secrecy of GRAS means that even basic questions of public health connecting exposures to alarming trends like obesity cannot be asked or answered appropriately.  The situation is untenable, and certainly far from Congress’s vision of FDA’s role in overseeing both public health and the safety of our food. 

FDA officials’ longstanding insistence that the agency cannot require notification of what is being used in the food supply is sadly, horribly mistaken.  Mandatory public notice of GRAS determinations by the food industry is not merely allowed; it is essential under the law’s general requirements for FDA to fulfill its Congressional assignment.  Rather than shooting itself in the foot with more baseless laments, FDA must put one foot in front of another and meet its legal obligation to assure the safety of all substances – both GRAS and additives – being used in food.

MacCleery is director of Regulatory Affairs at the Center for Science in the Public Interest.