Shooting Itself in the Foot on Food Safety:
Why the Food and Drug Administration (FDA) Has More Authority to Regulate
Food Ingredients than Some FDA Officials Admit
FDA has for too long blamed its poor oversight of substances in the food supply on a lack of
statutory authority. Currently, the agency permits food and chemical companies to exploit a
longstanding loophole in oversight of food additives for substances that are “generally recognized as
safe,” or GRAS. Back in 1958, when it enacted the Food Additives Amendments (FAA), Congress
intended for FDA to exercise comprehensive authority over the safety of the food supply. In recent
decades, however, the agency has permitted companies to secretly determine the safety of substances
and introduce them into food without even any notice to FDA. Such determinations have been criticized
by the Government Accountability Office and others for being rife with conflicts-of-interest.
CSPI and other organizations submitted lengthy comments to FDA in April 2015 charging that the
current lack of oversight of GRAS substances is illegal under the 1958 statute, and that FDA must assert
its authority to require notice of GRAS determinations in order to assure public safety. Yet some at
FDA appear determined to stick with an overly narrow view of FDA’s authority. Susan Mayne, the new
director of FDA’s Center for Food Safety and Applied Nutrition, remarked days after the filing in April
2015 at a meeting of the Food and Drug Law Institute 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.”
This view is dangerously incorrect and unsupportable under the law. Nowhere does the FAA, nor
the Food, Drug, and Cosmetic Act (FDCA) into which the FAA was folded, indicate that FDA may not
require notification of GRAS determinations. Instead, Congress intended FDA to have ongoing
oversight over all substances added to foods. The FAA’s stated purpose was “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.” For this reason, FDA clearly always has had –
but never used – the authority to develop a regulatory program to ensure consumer health is
protected.
FDA also has ample implied authority to require notice of determinations. Section 701(a) of the Food,
Drug, and Cosmetic Act (FDCA) vests the agency with the “authority to promulgate regulations for the
efficient enforcement” of the Act. This authority has been interpreted broadly and logically by the
courts, which found that 701(a) allows FDA to issue rules that “effectuate a congressional objective
expressed elsewhere in the Act.” FDA’s authority under Section 701(a) has been “broadly construed to
uphold a wide variety of assertions of regulatory power” by reviewing courts, and, thus, the agency’s
assertions of authority would withstand any legal challenge so long as they were reasonably related to an
authorized purpose. Those provisions give FDA the authority to require notification because it is
necessary to make the statute work as Congress intended.
Because the program can only function as intended when FDA is notified about all substances added to
foods, it is clear that the agency has implied authority to require mandatory notification.
Congress expressed its clear intent in the FAA, which has several features that require FDA to be
aware of what is being used in food.
First, FDA must ensure that “food additives” are properly subject to the legally required food
additive petition process. The FAA sets up the petition process for “food additives” with an exemption
for substances “generally recognized as safe.” In practice, FDA has failed to adequately regulate GRAS,
both by placing few limitations on what may be determined to be GRAS and by making notification
voluntary. As a result, as FDA knows, companies and industry groups regularly conduct secret GRAS
determinations, including for substances that should properly be considered food additives – for
example, substances that are novel, have no proven record of safety based on science or past use, or
have been flagged as unsafe by authoritative bodies. Today, only a few substances a year undergo the
food additive petition process, rendering this centerpiece of the 1958 law virtually irrelevant. For the
food additive definition to have meaning, FDA must be able to police industry’s use of the GRAS
exemption. It must also have the information it needs to require substances that are actually food
additives to be submitted for agency review through the legally required petition process.
Second, safety requirements under the statute require a cumulative exposure assessment, which
cannot be conducted by the agency or by industry under a system that allows secret GRAS
determinations. The FAA requires the safety of substances in food – for both additives and, by
regulatory extension, GRAS substances – to be assessed by considering the exposure of the population
to the substance and its cumulative effects. To do that, manufacturers and the agency must also
consider, under the law, “chemically and pharmacologically similar substances.” Thus, both FDA and
the food industry must be able to estimate what types of foods contain a substance and how much of a
substance, or of similar substances, are in the diet. The explicit requirements of the FAA cannot be met
when notifications are voluntary, as this secrecy leaves both FDA and industry in the dark as to the
identity of that or similar substances in the food supply and the levels of their uses. This means that
both GRAS determinations and food additive petitions cannot be conducted as required by law.
Third, FDA has authority because mandatory notification to the FDA of GRAS determinations
provides the most efficient means to achieve the congressional objectives of the FAA. Section
701(a) gives FDA authority to promulgate regulations for the “efficient enforcement” of the Act. Courts
interpreting this provision have evaluated practical considerations to determine whether they are an
efficient means to achieve a statutory goal. In this case, FDA can only fulfill its statutory obligations
under the FAA if it is informed about usage and exposure of all substances, and mandatory notification
obviously provides by far the most efficient way to obtain this information. A reporting requirement
would, of course, be far more efficient than the random audits that FDA proposed in 1997 in a
rulemaking on GRAS: the secrecy of the current program means that the audits would be truly random
and could not be targeted in any systematic or meaningful way for public safety.
For these reasons – as well as the sorry history of FDA’s lack of oversight of substances in food under a
voluntary program – the FDA’s repeated insistence that it cannot require notification is sadly mistaken.
Mandatory notification of GRAS determinations by the food industry is not only allowed, it is
required for FDA’s program to meet its assigned legal goals of assuring the safety of the food
supply.