You grab a colorful seltzer from the cooler, its label promising “calm” and “focus.” Next to it, a bag of gummies boasts “sleep support,” and a snack bar is infused with something to “take the edge off.” In the modern wellness market, our food and drinks are increasingly expected to do more than just nourish; they’re designed to alter our mood, enhance our performance, and improve our health. But what’s really behind these enticing claims?
For years, consumers have navigated a murky marketplace where novel ingredients appear on shelves with little explanation of their regulatory status. In a landmark move toward transparency, the U.S. Food and Drug Administration (FDA) in July 2023 took a decisive step to clear the fog. The agency released its first-ever Public Inventory of Unapproved Food Additives [1], a “hit list” of substances that have been marketed in food products without the necessary pre-market review and approval.
This isn’t just bureaucratic shuffling. This list, featuring popular substances like Cannabidiol (CBD), Delta-8 THC, and even melatonin, signals a major shift in food safety enforcement. It empowers consumers with crucial information and puts the booming “functional foods” industry on notice. So, what does this inventory mean for you, and how can you use it to protect your health?
What Exactly is the FDA’s Public Inventory?
First, it’s important to understand what this list is—and what it isn’t. It is not a recall list. Instead, think of it as a transparency tool. The inventory compiles substances that the FDA has determined are being illegally added to foods.
Under federal law, any substance intentionally added to food is considered a food additive. That substance is subject to pre-market review and approval by the FDA unless it is “Generally Recognized as Safe” (GRAS) by qualified experts for its intended use [2]. The substances on this new public inventory have met neither of these criteria. They have not gone through the FDA’s rigorous safety review process, nor are they considered GRAS for use in conventional food.
The primary purpose of this inventory is to:
- Inform the public about what the FDA has already determined to be illegal additives.
- Alert manufacturers and distributors that these substances are not permissible in the food supply.
- Create a clear, centralized resource for state and local regulatory partners.
Spotlight on the Key Unapproved Additives
The initial list contains several headline-grabbing ingredients that have exploded in popularity. Their inclusion provides a fascinating case study in how the market can often outpace regulation.
1. Cannabidiol (CBD): The Wellness Darling Under Scrutiny Arguably the most prominent substance on the list, CBD is everywhere. It’s infused in everything from coffee and sparkling water to olive oil and cookies. Marketed as a panacea for anxiety, pain, and inflammation, CBD’s rise has been meteoric.
The FDA’s Stance: The FDA’s position is firm and multifaceted. A key reason CBD is not allowed in food is that it is the active ingredient in an approved prescription drug, Epidiolex, used to treat seizure disorders. Federal law prohibits adding an active drug ingredient to conventional foods or marketing it as a dietary supplement. Beyond this legal barrier, the FDA has repeatedly expressed significant safety concerns. The agency points to a lack of scientific data on the long-term effects of daily CBD consumption [3]. Potential health risks cited by the FDA include:
- Liver Injury: Studies have shown that CBD can elevate liver enzymes, a potential sign of liver damage.
- Drug Interactions: CBD can interfere with other medications, potentially leading to dangerous side effects.
- Male Reproductive Toxicity: Research in animals suggests CBD can impact the male reproductive system.
- Cumulative Exposure: The FDA is concerned about how much CBD a person might unknowingly consume from multiple sources throughout the day.
By placing CBD on the inventory, the FDA is sending a clear message: despite its ubiquity and “natural” reputation, it has not been proven safe for use as a food additive.
2. Delta-8 THC: A Legal Gray Area with Real Concerns A close cousin to the more famous Delta-9 THC (the primary psychoactive component in marijuana), Delta-8 THC exists in a complicated legal space. It is typically synthesized from hemp-derived CBD and produces a milder “high” than traditional THC. This has allowed it to be sold in many states where cannabis remains illegal.
The FDA’s Stance: The agency has issued multiple warnings about Delta-8 THC products [4]. Its concerns are twofold:
- Lack of Evaluation: Like CBD, Delta-8 has not been evaluated or approved by the FDA for safe use in any context. Its health effects are largely unknown.
- Unsafe Contaminants: The chemical synthesis process used to create Delta-8 from CBD can be uncontrolled, potentially introducing harmful byproducts and unknown chemicals into the final product.
- Public Health Risk: The FDA has received numerous adverse event reports, including vomiting, hallucinations, and loss of consciousness. Furthermore, these products are often packaged as gummies and chocolates, making them dangerously appealing to children.
Its inclusion on the inventory solidifies the FDA’s view that Delta-8 THC has no place in the nation’s food supply.
3. Melatonin: The Sleep Aid Sneaking into Snacks This one may come as a surprise. Melatonin is widely sold as a dietary supplement for sleep. So why is it on a list of unapproved food additives? The distinction is critical.
The FDA’s Stance: A substance can be legal for sale as a dietary supplement but illegal to add to conventional food. Dietary supplements are regulated under a different framework—they are meant to supplement the diet and typically come in forms like pills, capsules, or tinctures. Food additives are ingredients that become part of a food itself, like a flour or a preservative. The FDA has not approved melatonin as a food additive. Its concern is the uncontrolled dosage and widespread availability in appealing food formats like “sleepy-time” brownies, drinks, and gummies [5]. This can lead to consumers, especially children, ingesting unknown and potentially unsafe quantities of a neurohormone. The long-term effects of chronic melatonin use, particularly on childhood development and reproductive health, are not well understood.
The Crucial Difference: Food Additive vs. Dietary Supplement
Understanding the FDA’s inventory requires grasping the regulatory wall between food additives and dietary supplements.
- Food Additives: Must undergo a rigorous pre-market safety review by the FDA before they can be sold, unless their use is GRAS. The burden of proof for safety is on the manufacturer.
- Dietary Supplements: Do not require pre-market approval from the FDA. Manufacturers are responsible for ensuring their products are safe, but they don’t need to provide efficacy or safety data to the FDA before marketing. The FDA’s role is primarily reactive—it can take action after a product is on the market and found to be unsafe.
Adding melatonin or CBD to a seltzer or cookie moves it from the less-regulated supplement category into the strictly controlled food additive category, a line that many companies have crossed illegally.
What Can You Do as an Informed Consumer?
This new inventory is a powerful tool, but food safety remains a shared responsibility. Here’s how you can be a more vigilant consumer:
- Read the Ingredient List, Not Just the Hype: The front of the package is marketing. The truth is in the Nutrition Facts panel and the ingredient list. If you see CBD, cannabidiol, hemp extract (that isn’t hemp seed oil), or melatonin listed, know that the product contains an unapproved food additive.
- Be Skeptical of Drug-Like Claims: If a food or beverage claims to treat anxiety, cure insomnia, or provide any other therapeutic effect, it’s a major red flag. Only approved drugs can legally make such claims.
- Consult the FDA’s Inventory: The public list is available online. Check it if you’re unsure about an ingredient you see advertised.
- Report Adverse Events: If you have a negative reaction to a food product, report it to the FDA’s MedWatch program [6]. This data is crucial for helping the agency identify and act on dangerous products.
- Favor Reputable Brands: Choose products from established manufacturers who demonstrate a commitment to transparency and regulatory compliance.
The Future of Food Safety and Transparency
The FDA’s Public Inventory of Unapproved Food Additives is more than just a list. It’s a declaration that the era of “anything goes” in the functional food space is coming to an end. It represents a crucial step toward harmonizing innovation with consumer safety. As consumers, we must continue to demand this transparency and use the tools provided to make informed choices. The next time you reach for that “calming” beverage or “sleepy” snack, take a moment to look past the promises and read the label. Your health might just depend on it.
References
1.Rimsys. “MedWatch: The FDA Safety Information and Adverse Event Reporting Program.” https://www.rimsys.io/blog/medwatch-the-fda-safety-information-and-adverse-event-reporting-program
2.Perkins Coie. “FDA Releases Public Inventory of Unapproved Food Additives.” https://perkinscoie.com/insights/update/fda-releases-public-inventory-unapproved-food-additives
3.eCFR. “Title 21, Part 170.” https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-170
4.Centers for Disease Control and Prevention (CDC). “About Cannabidiol (CBD).” https://www.cdc.gov/cannabis/about/about-cbd.html
5.U.S. Food and Drug Administration (FDA). “5 Things to Know about Delta-8 THC.” https://content.govdelivery.com/accounts/USFDA/bulletins/2f146f5
6.National Library of Medicine. “Melatonin as a Food Additive.” https://pmc.ncbi.nlm.nih.gov/articles/PMC8958662/
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