Earlier this week, the Food and Drug Administration (FDA) said it would move to revoke a longstanding agency-authorized claim that soy-based foods can protect heart health. If an FDA rulemaking on the matter succeeds, the reversal on soy would be the first such revocation by the agency.
In proposing the change, the FDA says there simply isn't enough evidence to support an agency-authorized claim.
"We are proposing a rule to revoke a health claim for soy protein and heart disease," said the FDA's Susan Mayne, in a statement announcing the move this week. "For the first time, we have considered it necessary to propose a rule to revoke a health claim because numerous studies published since the claim was authorized in 1999 have presented inconsistent findings on the relationship between soy protein and heart disease."
The soy food industry is unhappy with the FDA's plans.
"The Soyfoods Association of North America is concerned that the FDA is proposing to modify the claim from unqualified to qualified," the group, which represents makers of soy foods, said in a statement this week. The group also says it will fight the proposed change.
I have no opinions about whether or not soy proteins (or any other foods) are good for you. Eat what you like, I say, or what you think you should eat. Or don't.
But I do have opinions about both the FDA's move this week and, more generally, the agency's dominion over food-related health claims.
The agency's authority over these (and other) claims dates to 1990, after Congress passed the Nutrition Labeling and Education Act (NLEA). The law established "procedures whereby FDA is to regulate health claims on food labels[.]" FDA regulations soon followed.
Since passage of the NLEA, the FDA has approved a dozen health claims, including, for example, a claim that some fruits and vegetables can lower a person's risk of developing cancer, along with the claim that soy proteins can help lessen the risk of heart disease.
While the FDA's skepticism about soy might be new, others have long questioned health claims related to soy foods, notably even at least as far back as the proposed FDA soy rule.
"In September 1998, the Center for Science in the Public Interest [discussed] 'the overblown—and under-substantiated—world of soy claims,'" writes Marion Nestle, in her book Food Politics. "This skepticism was soon justified by independent studies suggesting that substituting soy for other proteins in the diet might have little effect on the coronary risk of North Americans."
Though this is the first time the FDA has ever reversed course on its approval of a health claim, this is hardly the first time the agency has reversed its position on a food or food ingredient. In the 1970s, the agency attempted to ban the legal sweetener saccharin. The agency banned interstate sales of raw milk in the 1980s, after a federal court forced the agency's hand. Most recently, the agency banned oils that contain partially hydrogenated trans fats.
Even if it's successful, the FDA's proposal to revoke soy's existing health claim won't mean the end of food labels touting the connection.
Among other avenues, the agency says it'll permit makers of soy foods to continue to tout the connection through the use of another NLEA tool, the "qualified health claim, which requires a lower scientific standard of evidence than an authorized health claim[.]"
"Regardless of the outcome for this particular claim, the law already allows food companies to make scientifically-valid claims, and whatever FDA does won't change that," says Michele Simon, executive director of the Plant Based Foods Association, in an email to me this week. "It also indicates the challenges for FDA in keeping up with all the latest science, which points to the need for more flexibility for companies, again as along as their claims are backed up by good science."
I agree with Simon that the FDA should be flexible. And I'll take her a step further by repeating my longstanding mantra about food labels: they should be open to any and all statements about a food that aren't demonstrably false. That issue rests properly with courts, not the FDA.