By David Williams | President of the Taxpayers Protection Alliance
By now, most parents have warned their kids against eating unwrapped candies while trick-or-treating under ghoulish guise. While most of the stories surrounding poisoned Halloween candy have been debunked, there is a kernel of truth behind these scary tales. Dozens of kids fell ill after Halloween night of 1950 because their candies contained a food dye called “Orange No. 1,” which the FDA thought was safe but turned out to be toxic.
The horrific 1950 episode led to legislation strengthening the agency’s food additive process, and now, synthetic ingredients are subject to a lengthy and costly premarket approval process. Unfortunately, this overcorrection has made it difficult to incorporate new and safe ingredients into consumer goods. The status-quo feeds into double-digit candy inflation and undermines the integrity of the food supply. It’s time for Congress and the FDA to rethink its spooky regulations and strike the right balance between safety and innovative ingredients.
According to the FDA, companies going through the food additive process will have to wait about 2 years before getting an approval or rejection from the agency. But, for truly novel ingredients on the cusp of patentability, the process takes considerably longer. As University of Missouri legal scholar Erika Lietzan notes, “[t]he average length of time for FDA to review and approve the twelve [novel] food additive petitions for which we have data, however, was 2,298 days, or 6.3 years.”
The time needed for approval can vary considerably depending on concerns raised by consumer groups and competing companies. Sham regulatory filings by competitors are a real threat and, according to University of Florida legal scholar Lars Noah, “parties have made anonymous submissions late in the agency’s internal review process apparently to create unwarranted delays in the issuance of food additive regulations.” It took the FDA an astounding 11 years to approve a zero-calorie sweetener called sucralose (commonly sold as “Splenda”) despite the substance being considerably healthier than sugar. The FDA insisted on eleven additional studies to demonstrate the substance’s safety and sucralose ultimately passed with flying colors. But the costly, protracted process ate into the petitioner’s patent period, and the company filing the petition received “only two years of patent life back” for more than a decade’s worth of trouble.
Plenty of additives fail to make the final cut due to flimsy concerns. Because of the “Delaney Clause” of the Federal Food, Drug, and Cosmetic Act, the FDA cannot approve any food additive found to cause cancer in animals or humans. This creates a huge hurdle for approval because plenty of perfectly safe foods and ingredients have been found in one study or another to cause cancer in rats or mice. Even egg whites can be “demonstrated” to be carcinogenic in certain rodent populations. This absurdly low risk threshold (reminiscent of the World Health Organization’s flawed carcinogen crusades) has resulted in the FDA barring perfectly safe substances from the food supply.
Food safety experts Steve Armstrong and George E. Dunaif recount that, in 2018, the “FDA took the unusual step of banning six synthetic flavors that it knew were safe and which consumers had been eating for many decades.” These flavoring agents had been extensively studied over the past five decades and long been used to mimic naturally occurring tastes in foods such as candy, chewing gum, and ice cream. But because consumer and environmental groups submitted studies linking the additives with cancer in lab animals, the FDA was forced to pull the products from the market. This legal and regulatory uncertainty benefits no one, including consumers straddled with more expensive foods and drinks. The food additive process also makes foods less healthy by giving producers fewer sugar and fat substitutes to work with.
Lawmakers and agency officials must work together to reform the process and keep trick-or-treaters safe and satiated. For starters, Congress should scrap the Delaney Clause and insist on a holistic risk assessment that takes all available evidence into account. Additionally, the FDA should insist that its regulators expedite the additive approval process and relegate additional studies to post-approval market surveillance efforts. Costumed cadavers and killer clowns deserve the treat of cheaper, safer candies this and every Halloween.