The Caramel Case: Federal Preemption Would Be Sweet, Prop 65 The Sundae

The federal/state regulatory disconnects under California’s Prop 65 – a priority target in the cosmetics industry’s preemption explorations on Capitol Hill – are distinctly embodied by caramel, a color additive approved by FDA that nevertheless may require warnings on products sold in the Golden State.

Caramel is an FDA-approved color additive for use in foods, drugs and cosmetics, but according to California, carcinogenic constituents lurking in the substance may warrant safety warnings on caramel-containing products.

The situation illustrates the federal/state disconnects seen under California’s Prop 65, industry’s foremost target in efforts to legislate retroactive preemption as part of cosmetics regulatory reform.

Pam Busiek, head of the Independent Cosmetic Manufacturers and Distributors, underscored preemption’s importance during the trade group’s recent regulatory workshop. (Also see "‘Something’s Going To Happen’: Former FDAer John Bailey On Cosmetics Reform Legislation" - HBW Insight, 21 May, 2018.)

“Places like California – I love the state. I just don’t like the regulatory framework. California cannot overrule our federal government,” Busiek said.

From ICMAD’s perspective, that’s precisely what happened with caramel, or more specifically, with the state’s listing of substances under Prop 65 that implicates the widely used flavor and colorant.

Both 4-methylimidazole and furfuryl alcohol form as a result of heating in the manufacturing process, and according to online sources, both compounds are known to be present in caramel.

They figure among the more than 1,000 chemicals that comprise California’s growing Prop 65 list. Furfuryl alcochol was added more recently, in September 2016, due to cancer concerns that industry maintains are not supported by science.

4-MEI is a similar story, folded into Prop 65 owing to carcinogenicity signals that FDA agrees are questionable in terms of the risks potentially posed to consumers.

On its website, the agency notes the limitations of the National Toxicology Program rodent testing that triggered the Prop 65 listing. “These NTP studies were conducted in rodents at levels of 4-MEI that far exceed current estimates of human exposure to 4-MEI from the consumption of Class III and Class IV caramel coloring in food products such as colas,” FDA explains.

“Based on the available information, FDA has no reason to believe that there is any immediate or short-term danger presented by 4-MEI at the levels expected in food from the use of caramel coloring.

Pending further investigation, “FDA is not recommending that consumers change their diets because of concerns about 4-MEI,” it adds.

Nevertheless, brands including Pepsi have been impacted most visibly by the Prop 65 listing, with PepsiCo Inc. settling a related class action in 2016, agreeing to work with its caramel coloring suppliers to keep 4-MEI levels within a range determined by California to be safe for consumption.

John Bailey of EAS Consulting, who served previous stints as director of FDA’s cosmetics office and chief scientist at the Personal Care Products Council, added to the discussion in his presentation at the ICMAD event.

“When FDA reviewed [caramel], and I was involved in that review, we considered all of those aspects – contaminants, degradation products. Caramel is a cooked sugar,” Bailey explained, “and you cook it in a controlled way in different conditions to get caramel color that’s good for beer, caramel color that’s good for Coke, caramel color in all kinds of variations. You do get some degradation, and those products are pretty well known and were considered when FDA reviewed caramel for listing as a color additive.”

He concluded, “So those are the incongruities that you get with Proposition 65.”

The Challenge For Cosmetics

For cosmetics, caramel is approved by FDA for certification-exempt colorant use, including in eye-area cosmetics, in amounts consistent with good manufacturing practice.

In an email to Rose Sheet, David Steinberg of Steinberg & Associates, who served previously as president of the Society of Cosmetics Chemists, said the big question before cosmetic manufacturers is whether 4-MEI and furfuryl alcohol can be detected in caramel-colored products in amounts that require a Prop 65 warning.

California has set the no significant risk level for 4-MEI at 29 micrograms per day. The state has not yet established an exposure threshold for furfuryl alcohol.

Prop 65 “leaves industry to try and come up with their own safe harbor exposure when using caramel as an ingredient,” regulatory consultant David Steinberg said.

NSRLs for suspected carcinogens under Prop 65 are defined by OEHHA as “the level of exposure that would result in not more than one excess case of cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime.”

If challenged, the burden falls on manufacturers to demonstrate that their products containing Prop 65-listed chemicals do not expose consumers at higher levels.

With respect to 4-MEI and furfuryl alcohol, Prop 65 “leaves industry to try and come up with their own safe harbor exposure when using caramel as an ingredient,” Steinberg said.

He continued, “To do this they must know how much exposure there is to the color and how much of these two chemicals are present. I know of a couple of toxicologists who do these types of calculations. Who pays?”

Caramel is just one example of the headaches Prop 65 imposes on industry. Given the law’s compliance challenges and the legal risks associated with Prop 65 in California’s opportunistic litigation climate, the program is a priority target for elimination in industry’s drive to include federal preemption in regulatory reform legislation before Congress.

Achieving meaningful, retroactive preemption as a part of that legislation is a tall order, and could be the “deal breaker” in negotiations, according to stakeholders close to the process.  (Also see "‘California’s A Problem,’ But Prop 65 Preemption For Cosmetics Could Be Out Of Reach" - HBW Insight, 31 May, 2018.)