FDA Initiates New Safety Review of Butylated Hydroxyanisole (BHA) Food Additive

The Food and Drug Administration (FDA) has begun a comprehensive safety review of butylated hydroxyanisole (BHA), a widely used food additive found in many processed items, including meats and bread. This action comes after decades of BHA's presence in the food supply and persistent concerns about its potential health implications.

Background on BHA

BHA has been utilized in the food supply for decades, initially listed as "generally recognized as safe" (GRAS) in 1958 and formally approved as a food additive in 1961. Its primary function is to prevent fats and oils in food from spoiling, thereby extending shelf life. It is present in a wide variety of products, including frozen meals, breakfast cereals, cookies, ice cream, and certain meat products, serving as an antioxidant.

Reasons for the Review

The agency is re-evaluating BHA due to existing concerns that the food additive might cause cancer in humans. Research linking BHA to cancer in animals dates back to the 1980s and 1990s.

In the 1990s, the National Toxicology Program identified BHA as "reasonably anticipated to be a human carcinogen" based on these animal studies. The chemical is also listed as a known carcinogen under California’s Proposition 65, further highlighting these concerns.

It's important to note that while animal studies have indicated a link, human studies on BHA's carcinogenic effects are currently limited.

FDA Actions and Public Input

As part of its ongoing review process, the FDA is taking a transparent approach by issuing a request for information. This process actively invites the public and industry to submit comprehensive data regarding BHA's current usage and safety profiles. This input will be crucial for the agency's re-evaluation.

Broader Context in Food Safety

This review occurs amid a wider focus on chemicals within the food supply, reflecting an increased scrutiny of food additives in general. Previously, there was a plan announced to phase out all artificial dyes from the food supply, following claims of links to behavioral problems in children – a connection the FDA is monitoring but has not yet confirmed. In line with consumer demand for natural alternatives, the FDA has approved "natural" dyes, including beetroot red and the expanded use of spirulina extract.

Expert Commentary on BHA

Marion Nestle, professor emerita of nutrition, food studies, and public health at New York University, weighed in on the challenges inherent in assessing BHA's safety for human consumption.

She noted that previous toxicology studies rely on lab and animal experiments, and the direct translation of these results to humans is not always clear. Nestle added that conducting human studies is difficult due to extensive time, cost, and ethical considerations.

Despite these research complexities, Nestle supported the FDA's current review, mentioning that BHA has long been on the Center for Science in the Public Interest's (CSPI) "avoid" list due to its questionable safety profile.

The Consumer Brands Association did not immediately respond to a request for comment regarding the FDA's new safety review.