"Natural" and "All Natural" Claims Still Undefined

Three years ago, I wrote an article for Nutritional Outlook that asked, “Why is FDA reluctant to define natural?” At that time, FDA had just issued a warning letter addressing, for the first time in nearly 10 years, a company’s use of the term natural.

While the optimist in most of us hoped that the warning letter symbolized a newfound agency interest in natural labeling claims that would, perhaps, finally prompt a formal definition of the term, three years later, it appears that we are nowhere closer to getting a formal definition. If anything, the course of the past three years has shown that the term natural is not likely to be decided from a regulatory standpoint any time soon, leaving courtrooms as the battleground for determining what natural really means.

Warning Letters

In my 2011 Nutritional Outlook article, I discussed the March 2011 FDA warning letter sent to a company over use of the term natural in the labeling of a product that contained sodium benzoate, a well-known synthetic chemical preservative. I wrote that the agency continued to decline to define natural in any regulation or formal policy statement, and that:

Instead, when questions over "natural" arise, FDA usually refers back to a statement made in a January 6, 1993, guidance regarding labeling. Essentially, FDA’s informal policy based on that statement is that the term "natural" means “any food in which nothing artificial or synthetic has been included or has been added to a food that would not normally be expected to be in the food.” With only this informal policy statement on which to rely as the definition for "natural," FDA has taken little action against companies for improperly using the term.

Since 2011, FDA has posted a grand total of four warning letters addressing the word natural or all natural claims. Two of those letters were issued in 2013 (the most recent in July 2013): (1) One to a cracker company that claimed a product was “all natural,” while the product contained artificial rye flavor¹, and (2) One to the marketer of a seafood product containing imitation crab meat comprising at least four synthetic ingredients.²

The other two letters were sent in 2011 over the use of all natural claims on products containing disodium dihydrogen pyrophosphate³ and potassium sorbate,⁴ both synthetic chemical preservatives. In each of those letters, FDA again reiterated its current policy regarding use of the term natural on food labeling, which is that “nothing artificial or synthetic (including all color additives regardless of source) has been included in or has been added to, a food that would not normally be expected to be in food.”⁵ The ingredients at issue were clearly artificial or synthetic ingredients, raising little question that the claims of naturalor all natural do not apply. However, for many other products, it is less clear as to whether certain ingredients are “artificial,” “synthetic,” or “normally expected to be in a food.”

Ongoing Litigation

The lack of a clear, formal definition of natural or all natural has paved the road to a steady stream of class action lawsuits attacking companies’ use of these claims. While FDA has issued only four warning letters over natural or all natural claims in the last three years-signaling the agency’s lack of interference with the natural controversy- the litigation arena has been nowhere near as idle on the subject. Litigation over natural and all natural has exploded over the last several years, as widely documented in countless blogs, articles, presentations, and discussions, and continues to be a growth industry for plaintiff lawyers.

Plaintiff lawyers have been indiscriminate in their targets. Products under fire include juices, granola bars, soups, chips, salsas, yogurts, ice cream, alcoholic beverages, shampoos…the list goes on. Class actions have hit manufacturers, suppliers, and marketers of food, beverage, supplement, and cosmetic products, big and small. Even retailers have been on the receiving end of class action lawsuits.

In these lawsuits, ingredients targeted as “unnatural” include the original “perpetrator,” high-fructose corn syrup; as well as synthetic preservatives; alkalized cocoa; common ingredients like ascorbic and citric acid; and, more recently, genetically modified organisms (GMOs). In fact, it seems that a day doesn’t go by without a new lawsuit filed against a food or beverage company regarding use of the terms natural or all natural.

In 2013, three different federal courts with pending class action lawsuits involving claims of natural or all natural stayed or administratively terminated litigation to ask FDA for input on the definition of natural, especially with respect to GMOs. While other courts dealing with the issue of all natural claims and high-fructose corn syrup have previously tried to get the agency to define natural, to no avail, the hope was that the recent marked increase in litigation would move this topic up on FDA’s agenda.

But that is not the case, it seems. On January 6, 2014, FDA sent a letter to the three United States District Court Judges that had entreated FDA to weigh in on the natural debate with respect to GMOs. In that letter, FDA respectively declined to make a determination as to whether products containing GMOs may or may not be labeled natural. FDA instead indicated that “priority public health and safety matters are largely occupying the limited resources that FDA has to address foods matters” and that it “must prioritize which issues to address.” Clearly, natural claims are not one of those issues.

Defending Natural

Natural and all natural were once the claims to make for products in the health food industries; now, however, companies often find themselves defending their natural and all natural claims in courts around the country. Without a clear definition to point to, many of these cases take months, if not years, to resolve. Plaintiff lawyers are well aware of this fact. There is, in fact, little downside to bringing litigation, outside of the time involved in bringing a lawsuit that may be dismissed.

Notably, no case has yet gone all the way through to trial for a judge or a jury to make a determination as to what constitutes natural. Most cases are either settled at an early stage-usually when a company decides it doesn’t have the means or the desire to continue in protracted and expensive litigation-or cases are dismissed for reasons such as pre-emption; primary jurisdiction; or failure of a plaintiff to certify a class, turning a case with potentially several million dollars at stake into a case over the cost of one or a just handful of products. (Certifying a class is what makes a class action lawsuit worth millions of dollars-or ten dollars. If the class gets certified, then the case becomes a class action lawsuit with potentially several thousand or more plaintiffs fighting over millions of dollars. If a plaintiff fails to get the class certified, however, the case becomes just a solo case and the plaintiff is usually left fighting over a couple of products that he or she bought for a total of $5-$10.) 

What’s a Company to Do?

Where does this leave companies wanting to make natural or all natural claims? First and foremost, a company has to review its labels and make sure that it is confident that it can support any claims made; if it can’t, it should forgo those claims.

Secondly, a company needs to evaluate the importance of those claims within the overall marketing of the product. Simply put, is it worth making the claim? As has been shown, a company may be fully justified in making such a claim and, yet, may still need to evaluate the potential costs of defending its claims in a costly lawsuit.

In its January 6, 2014, letter to the federal judges involved with all natural litigation, FDA indicated that the agency might be more inclined to address the natural controversy through an administrative request-such as a citizens’ petition-rather than responding to a request in private litigation. Until such time, companies are still very much on their own regarding whether to market products as natural.

*This article is issued for informational purposes only and is not intended to be construed or used as general legal advice. The opinions expressed are those of the author exclusively.

References

1. Warning Letter to Philemon Pty Ltd. (July 26, 2013), www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm364729.htm
2. Warning Letter to Key Ingredient Market (June 17, 2013), www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm357723.htm
3. Warning Letter to Alexia Foods (November 16, 2011), www.fda.gov/iceci/enforcementactions/warningletters/2011/ucm281118.htm
4. Warning Letter to Bagels Forever (July 22, 2011), www.fda.gov/iceci/enforcementactions/warningletters/2011/ucm265756.htm
5. Federal Register, vol. 58, no. 3 (January 6, 1993): 2302, 2407