Propylene glycol (PG) is an FDA-approved synthetic substance widely used as a solvent in ‘natural flavors‘– which are clearly defined in law. But would consumers expect to find it in a product marketed as ‘all-natural’ – a term that doesn’t have a clear legal definition? Not according to a class action lawsuit filed against Hint Inc this week.
In the complaint*, filed in California on January 17, plaintiff Lisa Kim Madrigal – represented by the Joseph Farzam law firm – says “independent and reliable testing of sample Hint Flavored Water products reveals the material presence of propylene glycol… a synthetic substance” that is “chemically manufactured and highly processed.”
The presence of a synthetic substance in the final product [the complaint does not specify at what level it found the substance] means that the beverage is not all-natural, argues Madrigal, who claims that Hint has violated California's consumer protection laws and falsely advertised products containing “artificial” ingredients as “all-natural.”
“This [‘all-natural’] claim is reinforced on Hint’s website, which depicts water and fruit and even shows a video of the CEO and creator of Hint, Kara Goldin, cutting pieces of fruit and placing them into the water to ‘infuse natural flavors…. These representations are false, deceptive and misleading.”
'Natural' is not defined in law, but 'natural flavor' is
So what does the law say?
As readers of FoodNavigator-USA will be aware, there is no legal definition of ‘natural’ or ‘all natural,’ just FDA guidance issued in 1993 noting that, “[FDA] has not objected to the use of the term [natural] on food labels provided it is used in a manner that is truthful and not misleading and the product does not contain added color, artificial flavors or synthetic substances.”
"We intend to defend ourselves rather than contribute to a toxic legal environment that encourages more and more lawyers to file these shakedown lawsuits."
Theo Goldin, COO, Hint Inc
However, there is a legal definition of natural flavors (21CFR501.22), which the FDA says means “the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional.”
And while synthetic solvents such as propylene glycol and hexane are not allowed in the production of organic certified products, they are permitted in ‘natural flavors,’ one industry source told FoodNavigator-USA.
'PG is a very common solvent. Especially in these days of Non-GMO'
And as long as the amount left in the final product has no functional effect, they do not need to be declared on the ingredients statement, as they are effectively operating as ‘incidental’ additives that are present in a food at insignificant levels and do not have any technical or functional effect in that food, added the source.
“If the flavor retains a ‘functional’ carry-over amount of an extraction solvent, this must be declared on the ingredient list. Thus a large amount of PG would be listed on an ingredient list (eg. Propylene glycol 50%, Natural flavoring 50%).
“PG is a very common solvent. Especially in these days of Non-GMO. Since it is synthetic, it is non-GM. Compared to glycerin and ethanol derived from plants that need a paper trail to prove non-GM, PG is a common go to - but as such, it is functional in the flavor as a carrier. However, if the use rate of the finished flavor in the water were really low, then they could determine that the PG is not functional and therefore not have to claim its presence.”
"The natural or artificial emulsifiers, solvents and preservatives in flavor mixtures are called 'incidental additives.' That means the manufacturer does not have to disclose their presence on food labels. Food manufacturers can use a natural solvent such as ethanol in their flavors, but the FDA also permits them to use synthetic solvents such as propylene glycol..."
What is propylene glycol?
“Propylene glycol… does not occur in nature. Propylene glycol is manufactured by treating propylene with chlorinated water to form the chlorohydrin which is converted to the glycol by treatment with sodium carbonate solution. It is also prepared by heating glyercol with sodium hydroxide.”
The GRAS-approved substance can serve as an anticaking agent, a dough strengthener, an emulsifier, a flavor agent, a formulation aid, a humectant, a processing aid, a solvent and vehicle, a stabilizer and thickener, a surface-active agent, and a texturizer.
So what do food law attorneys make of this case? Has the plaintiff simply misunderstood the law, or does she have a case here?
William Dance, an attorney at Tucker Ellis LLP, told FoodNavigator-USA: "It should be much easier to defend a ‘natural flavor’ suit because the FDA defines the term at 21 C.F.R. 101.22(a)(3). Provided the Hint, Inc. beverages at issue were produced in a manner consistent with that FDA rule, the manufacturer would be able to claim that the suit is preempted because it seeks to impose state laws that are different from and in addition to the federal regulatory scheme.
"Claims based on California’s reasonable consumer test would likely fail for the same reason, preemption."
I suspect the plaintiffs will argue that the natural flavors regulation does not cover the 'all natural' label
But could the plaintiffs argue that regardless of whether PG is allowed in ‘natural flavors,' the reasonable consumer would not expect PG to be in a product marketed as ‘all-natural’?
Amanda Groves, a partner at Winston & Strawn, told us: "An attack on the “natural flavor” ingredient description should be preempted given the definition of natural flavor provided in the regulations. [But] I suspect the plaintiffs will argue that regulation does not cover the 'all natural' label."
Dance at Tucker Ellis added: "I think this is a very interesting question. Arguments that use of the term 'all-natural' is preempted have generally failed, so plaintiffs are likely to find more traction dealing with that claim than with whether propylene glycol can be part of a natural flavor. But if the fact that it is part of a natural flavor is known and approved by the FDA, then can plaintiffs prevail in arguing that its presence renders the product not natural?"
Case could be stayed on primary jurisdiction grounds
That said, the FDA is currently probing 'natural' claims, and some 'natural' lawsuits have been stayed on primary jurisdiction grounds as a result, noted Groves, so the case could be put on ice: "The court certainly could decide, as many courts have, to wait for that guidance before proceeding.
"Given the detailed regulations surrounding natural flavors, and the highly technical nature of those issues, deferring to the FDA here seems particularly appropriate."
Hint COO: We intend to defend ourselves
Hint chief operating officer Theo Goldin told FoodNavigator-USA that the case lacked merit, adding: "No one likes to be the target of a lawsuit, but Kara and I have been so pleased with the supportive phone calls and emails we have received from other entrepreneurs in the healthy lifestyle and natural products industries.
"These folks are huge fans of hint water and I was shocked to learn that many of their products, products that we have enjoyed in our home and continue to enjoy have been the target of very similar or even identical 'shakedown' lawsuits.
"I say 'shakedown' because what I’m hearing is that many companies have agreed to pay what they consider a 'nuisance fee' rather than deal with the distraction of a protracted lawsuit. I suppose we could have done the same, but, you know, I just wouldn’t feel right about that. We’ve worked incredibly hard for 11 years to provide a truly healthy alternative to sugary and diet-sweetened drinks and we hear from our fans every day how much we’ve helped them meet their goals of drinking more water, losing weight, getting in shape and just plain feeling better.
“What are you going to say to a client? ‘You could pay $10,000 to get rid of this, or you can wait for them to file the case, we can move to dismiss it, and it can cost you $50,000 or $100,000 or more’.”
"They love our products because we make water taste great without making it taste sweet and that lets them drink a lot more water. So on behalf of our fans, ourselves and future entrepreneurs who will join us in trying to make the world a healthier place, we intend to defend ourselves rather than contribute to a toxic legal environment that encourages more and more lawyers to file these shakedown lawsuits.
"That defense will occur in a court of law. In the meantime, our focus remains on making the best tasting products, with the healthiest ingredients."
*The case is Lisa Kim Madrigal et al v Hint Inc BC 646991 filed on January 17 in the Superior Court of California, county of Los Angeles.