Celebrating 30 Years of Food Safety Magazine—and a Look Back at Food Safety Then vs. Now

In 2025, Food Safety Magazine marks its 30^th year of publication. Over the past three decades, FSM has changed its name, refined its focus, and transitioned from being an independently owned publication to joining the large family of distinctive B2B brands at BNP Media. What hasn't changed, though, is FSM's purpose: to serve the food safety community as the leading provider of science-based solutions for food safety and quality assurance professionals worldwide.

As we celebrate 30 years of delivering authentic, industry-sourced, quality, technical content to our audience, we invite you to take a look back with us at the food safety world of the mid-1990s. The first issue of FSM debuted in August of 1995—just a few years after the 1992–1993 Jack in the Box E. coli outbreak put food safety on the consumer and regulatory radars, and roughly one year before USDA-FSIS issued the Pathogen Reduction/HACCP Systems rule for the meat industry. The mid-1990s was a time of attention, movement, and decision in the food safety world. This attention and movement provided much of the impetus for the launch of Food Safety Magazine—which entered the media scene under its original title, Food Testing & Analysis (Figure 1).

FSM Revisits the Delaney Clause

The first several issues of Food Testing & Analysis focused on laboratory and microbiology concerns, along with the regulatory changes driving food safety/quality testing and analysis. One such issue in food safety, the Delaney Clause, was a hot topic of discussion in 1995. Enacted as one of several amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1958, the Delaney Clause prohibits the U.S. Food and Drug Administration (FDA) from approving food or color additives that have been "found to induce cancer" in laboratory animals or humans.

In the mid-1990s, the "zero risk" standard inherent in the Delaney Clause was among the issues being discussed in relation to FDA reform. While consumer advocacy groups have generally supported the "zero risk" standard, industry and FDA have long been arguing for a repeal or amendment to the Delaney Clause that allows for the approval of additives presenting a negligible or insignificant risk to human health.

In an article (Figure 2) appearing in the second issue of Food Testing & Analysis (October/November 1995), the former FDA Director of the Division of Field Science at the Office of Regulatory Affairs, Richard A. Baldwin, shared a historical perspective of the Delaney Clause and what it means for food processors. Baldwin noted:

At the time the Delaney Clause became law, good analytical techniques and technology might yield sensitivity to 50 parts per million (ppm). Today, parts per trillion or lower are common… Given such extraordinary analytical methodology advances, almost all substances, no matter how pure, can be shown to be contaminated with something else. If those contaminants cause cancer, then, theoretically at least, any food additive could be banned under the Delaney Clause—even one used in minute amounts posing little public health risk.¹

The Delaney Clause has been cited in many petitions over the years from consumer advocacy and public health groups asking FDA to repeal food additives already approved for use. For example, in October 2018, FDA removed seven synthetic flavoring substances from its list of approved food additives in response to 11 petitions by consumer, environmental, public health, and food safety advocacy groups. In its constituent update on the decision, FDA stated, "Although we are amending our food additive regulations for these synthetic flavoring substances in accordance with the Delaney Clause, the FDA's rigorous scientific analysis has determined that they do not pose a risk to public health under the conditions of their intended use."²

A Closer Look at Red Dye 3 and Delaney

We have seen the Delaney Clause play a prominent role in more recent regulatory decisions, as well. In response to a color additives petition filed by 24 advocacy groups in 2022, as well as a heated Senate hearing in December 2024 that scrutinized FDA's food safety work, FDA issued an order on January 15, 2025 to revoke the use of red dye no. 3 in food and oral drugs from January 2027.^3,4 Echoing the commentary from Baldwin in 1995 and FDA's previous revocations of food and color additives, FDA commented on the red dye 3 decision:

The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats. Studies in other animals or in humans did not show the same effect and there is no evidence showing FD&C Red No. 3 causes cancer in humans.³

Although the food industry has long advocated for the repeal or amendment of the Delaney Clause,⁵ the "zero risk" standard stands—and FDA must continue to adhere to it, however reluctantly. Groups that advocate for stricter food safety and public health regulations will continue to cite the Clause in their petitions to FDA. And as states move to ban food and color additives independently,⁶ food processors will increasingly be required to phase out food and color additives in response to reevaluations and revoked authorizations by FDA.⁷ Processors will also need to conduct more rigorous safety testing for any new additives—making the "zero risk" provision of the Delaney Clause an important regulatory factor to keep in mind.

In his 1995 perspective, Baldwin summarized the historical and then-current thinking on the effect of the Delaney Clause on food safety regulation and FDA action:

Over time, the Delaney Clause has come to symbolize, to some, the unwanted and unnecessary legislatively-imposed strictures on the flexibility of the agency [FDA] to make and implement sound scientific decisions. Some tend to view the clause as a symbol of anti-science, and reject the search for "absolute safety" that it engenders. The food industry's view also has evolved over time. For some, the Delaney Clause is perceived as perhaps one of the most important provisions of any federal food and safety law.¹

It seems that not much has changed in 30 years—with regard to Delaney, at least.

Keep your eyes peeled for more Food Safety Magazine 30^th anniversary coverage in our upcoming issues throughout the year, including more retrospectives of food safety "then vs. now!"

“Big data and AI technologies, such as machine learning, show promise for informing AMR surveillance and mitigation efforts.”

References

1. Baldwin, R.A. "A Historical Perspective of the Delaney Clause." Food Testing & Analysis. October/November 1995.
2. U.S. Food and Drug Administration (FDA). "FDA Removes 7 Synthetic Flavoring Substances from Food Additives List." October 5, 2018. https://www.fda.gov/food/hfp-constituent-updates/fda-removes-7-synthetic-flavoring-substances-food-additives-list.
3. FDA. "FD&C Red No. 3." January 15, 2025. https://www.fda.gov/industry/color-additives/fdc-red-no-3.
4. Food Safety Magazine Editorial Team. "FDA Bans Red Dye 3 in Food." Food Safety Magazine. January 15, 2025. https://www.food-safety.com/articles/10058-fda-bans-red-dye-3-in-food.
5. Wellford, H. and S. Epstein. "The Conflict Over the Delaney Clause." January 13, 1973. The New York Times. https://www.nytimes.com/1973/01/13/archives/the-conflict-over-the-delaney-clause.html.
6. Food Safety Magazine Editorial Team. "California Continues Targeting Food Additives, Dyes With Executive Order on Ultra-Processed Foods." Food Safety Magazine. January 6, 2025. https://www.food-safety.com/articles/10041-california-continues-targeting-food-additives-dyes-with-executive-order-on-ultra-processed-foods.
7. Henderson, B. "FDA Outlines its Developing Systematic Post-Market Review Process for Chemicals in Food." Food Safety Magazine. September 27, 2024. https://www.food-safety.com/articles/9775-fda-outlines-its-developing-systematic-post-market-review-process-for-chemicals-in-food.