Speaking at the American Conference Institute (ACI) food law and regulatory forum in Chicago this week, Miriam Maxwell, senior principal global regulatory scientist at Ocean Spray Cranberries, said plaintiff’s attorneys, as well as leading brands [click HERE] are probing deeper into processing methods and aids, incidental additives, pesticide residues and seeking out any ‘artificial’ components that lurk within, or have even come into contact with, ‘natural’ sounding ingredients, even if they are not present in the final product, and are not required by law to be listed on food labels.
Solvents, proprietary flavor formulations
When it comes to natural flavors, the proprietary nature of formulations can present challenges if you’re pushing suppliers to give you a comprehensive list of what’s in the product (which they likely won’t supply), she added.
But you can work with suppliers such that formulations remain proprietary but you still get the reassurances you need, she said.
For example, you could relay to your supplier that you plan to make all-natural claims [about an overall product containing that supplier’s natural flavor], lay out what your expectations are in relation to natural flavors and ask if the flavors conform with these expectations over specific solvents, for example.
“Perhaps you want to avoid anything with certain solvents or you have a list of permitted solvents and residue levels,” said Maxwell. “Maybe you don’t want to use anything with propylene glycol in it, for example [the incidental additive at the heart of a recent lawsuit against Hint Inc ]. People need to start having these conversations.”
Referring to potential lawsuits over incidental additives, she said, “It’s one of those areas where you can be technically right but you can still be challenged.”
Cane sugar, caramel colors
In many cases, asking questions about how ingredients are manufactured can also throw up information that directly impacts claims you are making about an overall product, she said, giving the example of cane sugar, which can be filtered and decolorized with bone char (from cattle bones), sometimes described as natural carbon.
Are you making a ‘vegan’ claim on a product containing cane sugar, and if so, are you certain that the sugar in question has been filtered without using bone char?
Just because the sugar itself does not actually contain bovine material, she said, would a reasonable consumer specifically seeking out vegan products for ethical or other reasons consider the sugar to be ‘vegan’ if she learned that superheated animal bones were used to manufacture it?
Caramel colors are also being increasingly scrutinized, in part because of questions over the source of the main raw material (eg. Have you checked you’ve got a non-GMO version if you’re making non-GMO claims), and in part owing to ingredients that may be used in its production.
For example, do you know whether your caramel color was manufactured using sulfite and ammonium compounds?
In all the above cases, the issue is not about the merits or otherwise of these ingredients (and leading suppliers of all the above products have options that address these concerns), she said. It's about ensuring that you are aware of what’s in your products and applying a risk assessment if you’re considering making ‘natural’ claims in particular, she said.
“The bigger you are, the more of a target you are.”
Focus on claims that have been defined in law or in certification schemes
Jo Osborn, VP and assistant general counsel at TreeHouse Foods, added that manufacturers are always on (relatively) safer ground if they try to stick to claims defined by government agencies (eg. organic, nutrient content claims such as ‘good source of…,’ approved health claims) or certified according to third party standards (Fairtrade certified, Kosher) rather than using more nebulous claims such as ‘natural,’ ‘locally sourced,’ ‘wholesome,’ ‘fresh,’ ‘simple,’ ‘pure’ or ‘real.’
Meanwhile, what the high-profile POM vs Coke lawsuit (click HERE) had highlighted, said successive speakers at the forum, was that sticking to the letter of the Food Drug and Cosmetic Act is not necessarily going to stop competitors or consumers coming after you with consumer deception (false advertising) claims. In other words, even if your label ticks all the boxes, would a ‘reasonable consumer’ find it truthful and not misleading?
As for ‘healthy’ claims, the recent FDA announcement that it would not enforce current regulatory requirements for products that use the term ‘healthy’ if they exceed the current 1g/serving for total fat but have a fat profile comprised mostly of healthier mono and polyunsaturated fats, “should be viewed with caution,” by all manufacturers other than KIND LLC, which was specifically told by the FDA that it’s ‘healthy’ labels were OK, said several speakers at the ACI forum.
While the FDA guidance might appear to give companies a license to make 'healthy' claims on a whole new set of products (nuts. avocados etc), one food industry counsel at the ACI forum said: “You’d have to do a risk analysis as the plaintiff’s bar is very active. Do the new criteria amount to a safe haven? I don’t feel comfortable using this new guidance [which the FDA stresses is non-binding] because a plaintiff’s lawyer can always say it’s not officially on the books.”
Given the Trump Administration’s de-regulatory bent, and its Jan 30 'two for one’ executive order, however, it’s likely that we will see more guidance, and draft guidance, as opposed to regulation, coming from government agencies, predicted Maxwell.
Sedgwick partner Anthony Anscombe added that with this in mind, we might see more clear disclaimers on FDA guidance and draft guidance: “I expect that a shift to the right could mean increased awareness within FDA as to how its statements may be used in civil litigation.”
“FDA's guidance documents, including this guidance do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. This guidance… is not binding on FDA or the public.”
FDA guidance on ‘healthy’ claims, September 2016
Read more from the ACI forum: