Artificial colors: FDA actions
The U.S. Food and Drug Administration (FDA) announced additional steps to support the transition of the nation’s food supply from the use of artificial petroleum-based colors to alternatives derived from natural sources. FDA explained that companies will now have flexibility to claim products contain ‘no artificial colors’ when the products do not contain petroleum-based colors. Previously, companies making such claims was generally allowed only if a product had no added color at all, whether derived from natural sources or otherwise.
“This is real progress,” said Health and Human Services Secretary Robert F. Kennedy Jr., in FDA’s announcement “We are making it easier for companies to move away from petroleum-based synthetic colors and adopt safer, naturally derived alternatives. This momentum advances our broader effort to help Americans eat real food and Make America Healthy Again” [MAHA].
FDA issued a letter to manufacturers announcing its intention to exercise enforcement discretion regarding section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act for products containing artificial colors. Provided they do not contain color additives subject to certification, per this discretion products containing artificial colors may make the following voluntary label claims:
- Made without artificial food colors/colorings
- No artificial color/colors/coloring
- No added artificial color/colors/coloring
FDA noted that color additives must still follow the general color additive petition process described at 21 CFR Part 71.
FDA also approved beetroot red, a new color option, and approved the expanded use of spirulina extract, an existing color additive derived from a natural source.
Explaining the move, FDA Commissioner Marty Makary, M.D., M.P.H., said: “We acknowledge that calling colors derived from natural sources ‘artificial’ might be confusing for consumers and a hindrance for companies to explore alternative food coloring options. We’re taking away that hindrance and making it easier for companies to use these colors in the foods our families eat every day.”
GNT, which offers EXBERRY colors from non-GMO fruit, vegetables, and plants, shared the news that the company supported the expanded use of spirulina. “With more natural blue options now permitted, the focus is on helping manufacturers understand what’s possible,” said Jane MacDonald, Director of Technical Development at GNT USA. “GNT brings regulatory experience and technical application expertise to support informed decision-making, as customers evaluate natural blue solutions within their specific formulations and commercial goals.”
FDA further stated that, while the Agency encourages manufacturers to transition to alternative and naturally derived colors, manufacturers are responsible for ensuring color additive safety. As such, FDA issued a letter that, among other things, highlights resources that may assist manufacturers of authorized color additives in maintaining high standards of safety and purity.
EWG expresses concerns
The Environmental Working Group shared a statement from President and co-founder Ken Cook: “This latest retreat on synthetic food dye regulations is another broken promise from Secretary Kennedy and President Donald Trump. They pledged outright bans on dangerous food chemical additives to their ‘Make America Healthy Again’ base. Instead, states are doing the hard work to protect families, while Kennedy settles for handshake deals with Big Food and chemical companies—agreements with no real accountability and no guarantee they’ll be honored.” EWG reported that in more than 25 states, legislation is being considered that would ban synthetic food dyes and other food chemical additives linked to ADHD and hyperactivity in children, among other concerns.
Age-restriction: The latest state efforts
As the Natural Products Association (NPA) has often warned, state legislation that seeks to restrict access to dietary supplements creates a dangerous precedent for other states to follow. Michigan, Alaska, and Hawaii are among the states considering such legislation now, and NPA has shared news of additional current state actions. In California, AB 2030 would “prohibit a person from selling, offering to sell, or giving away as either a retail or wholesale promotion, and a delivery seller from selling, delivering, or causing to be delivered, an over-the-counter diet pill or dietary supplement for weight loss or muscle building, as defined, to any person under 18 years of age by requiring a specified identification check.” Violations could come with a civil penalty of $1,000 each.
In addition, NPA reported, a hearing was scheduled in Connecticut regarding the prohibition of marketing of certain weight loss pills and supplements to minors.
“These bills underscore, in stark terms, why federal preemption is essential and not optional,” said
Kyle Turk, VP of Government Affairs, NPA. “Allowing a growing patchwork of state-by-state mandates to dictate dietary supplement policy weakens the coherent national framework that Congress deliberately established and undermines the U.S. Food and Drug Administration’s clear jurisdiction over these products. When individual states attempt to impose duplicative, conflicting, or scientifically unsupported requirements, they do more than create confusion. They expose responsible supplement brands and retailers to heightened liability risks, inconsistent compliance burdens, and market fragmentation rooted in political narratives rather than sound science or common sense.
“When Congress enacted DSHEA, it explicitly rejected an ‘ad hoc, patchwork regulatory policy on dietary supplements.’ The wave of recent state proposals attempts to resurrect precisely the fragmentation that Congress sought to avoid. Federal preemption reaffirms congressional intent, reinforces FDA’s authority, protects consumers through uniform, national standards, and shields businesses from a maze of conflicting rules that threaten innovation, access and interstate commerce.”
(Related: Setting the Record Straight on Dietary Supplements and Eating Disorders)
Heavy metal testing: New proposal in CA
In February, California Senator Steve Padilla introduced California Senate Bill 1033, which would require testing of heavy metal content in protein powder and public disclosure of those results. “Protein products can play a role in helping Californians meet their health and nutrition goals, but only if the products on store shelves are actually safe,” said Senator Padilla in his office’s announcement of the legislation. “Consumers deserve to know what they are putting into their bodies, and right now there’s a troubling lack of transparency when it comes to toxic heavy metals. We need to put common-sense guardrails in place to hold manufacturers accountable, require proper testing, and ensure families can trust that the products they buy won’t put their health at risk.”
The Council for Responsible Nutrition (CRN) voiced strong opposition to the bill, which it explained would impose state-specific testing, disclosure, and labeling mandates on protein powder and other concentrated protein products sold in California. While CRN supports science-based safety standards and transparency, the trade group said SB 1033 would create burdensome requirements outside the established federal regulatory framework and deliver “alarmist messages” to consumers disconnected from any actual harm.
“Dietary supplements are already regulated under a comprehensive federal framework that includes rigorous Good Manufacturing Practices and contaminant testing requirements,” said Steve Mister, President & CEO of CRN. “Layering additional state-specific mandates on top of that system is unnecessary and counterproductive. It creates regulatory fragmentation without improving consumer safety.” The organization added that modern analytical techniques can detect extraordinarily small trace levels of naturally occurring elements, but detection alone does not equate to risk.
CRN also pointed out that protein products are already subject to California’s Prop 65, which requires warning labels for items that exceed conservative thresholds for heavy metals. As a result, CRN said, California consumers are already alerted if a product exceeds the state’s permissible levels. SB 1033 would instead establish additional California-specific testing disclosures and labeling mandates, creating what CRN described as a parallel compliance regime unique to one state. This patchwork approach would require separate testing protocols, website disclosures, packaging revisions, and supply chain adjustments tailored to individual state requirements, CRN said, and this would affect companies of all sizes.
“The proliferation of inconsistent mandates across states could disrupt national distribution systems and increase costs for businesses and consumers alike,” Mister said. “A fragmented state-by-state system introduces uncertainty, inefficiency, and unnecessary expense across the marketplace.”
CRN emphasized its support for the federal Dietary Supplement Regulatory Uniformity Act, which reaffirms FDA’s authority as the national regulator of dietary supplements and prevents states from imposing conflicting or duplicative requirements. “Consumers are best served when there is one national standard—not a growing patchwork of state-by-state mandates,” Mister added, noting that CRN will continue to advocate for uniform, science-based oversight and is urging California lawmakers to reconsider SB 1033.
Self GRAS: Calls for reform
On a February 15 episode of 60 Minutes, HHS Secretary Kennedy discussed ultra-processed foods (UPFs) and the “self-affirmed GRAS” pathway. As WholeFoods Magazine has reported, HHS and FDA previously announced a commitment to “promoting radical transparency to make sure all Americans know what is in their food.” As part of that focus, Secretary Kennedy directed FDA to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway. HHS said this would enhance FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers.
Following the 60 Minutes segment, the Alliance for Natural Health USA (ANH-USA) urged policymakers to pursue major GRAS reform centered on risk prioritization and radical transparency. ANH-USA also warned against proposals that would “effectively force the U.S. Food and Drug Administration (FDA) to pre-review every GRAS determination, an approach that would be unworkable and could unintentionally restrict access to many beneficial, low-risk ingredients.”
While ANH-USA agrees with the core public health concern over UPFs, the group is challenging the view that over-consumption of UPFs is directly linked to GRAS.
“It is now evident that rising exposure and addiction to the specific combinations of industrially modified food ingredients, and increasing amounts of synthetic and bioengineered substances, are contributing to worsening metabolic health outcomes in the United States,” said Rob Verkerk, Ph.D., Executive and Scientific Director of ANH-USA. “It is also clear that some of these problematic substances have found their way into the food system through the ‘self-affirmed GRAS’ pathway—behind closed doors with neither FDA nor external scrutiny.”
Jonathan Emord, General Counsel for ANH-USA, added, “We fully support the need for GRAS reform—especially reform that ends secret GRAS and forces disclosure of the science related to ingredients for which there is evidence of harm, such as some used in UPFs. But if reform is reduced to ‘FDA must pre-approve everything,’ it will create a massive regulatory bottleneck and block access to countless low-risk health-enhancing ingredients commonly used in health foods, including functional foods, supplements, and medical foods. The answer is not to freeze the marketplace—it’s to reveal the evidence of harm and focus in on precisely those products containing harmful ingredients.”
Dr. Verkerk concluded: “Americans need real protection from harmful ingredients—and they also need continued access to beneficial ones. We can do both by ending secret GRAS and replacing it with radical transparency and risk-based oversight. In short: don’t throw the baby out with the bathwater.”
