Malic acid is a versatile ingredient that is commonly found in food and dietary supplement products. Lately, malic acid has become the target of a growing number of lawsuits.
Briefly, the suits allege that certain products are labeled as containing “no artificial flavors” but list malic acid as an ingredient. The suits continue by saying the artificial version of malic acid is being used in the products, and therefore, the consumers are being duped because the artificial version of this ingredient is not appropriately disclosed on the label. Some of the targeted companies include Campbell Soup Company, Frito-Lay North America, Kellogg Company, Bai Brands, Utz Quality Foods, Talking Rain Beverage Co., Ocean Spray Cranberries, Sunny Delight Beverages Co., among a growing list of others.
While malic acid exists naturally – it can be derived from fruits such as apples – the malic acid used in many food/supplement products is the synthesized version, also commonly referred to as DL-malic acid where the “DL” refers to the two isomers that are generated under laboratory conditions. The natural version exists as a single isomer and is denoted as L-malic acid.
Here is a very basic primer on what malic acid is:
As these lawsuits make their way through the courts, defense attorneys will have to recruit credentialed experts to effectively counter the allegations being made by plaintiffs. While each case will have nuances that might require a cadre of experts, we envision that at a minimum, the core team should consist of the following:
- A labeling expert in food/supplement products, and
- A food/supplement formulation and/or chemistry expert
- A food sensory expert.
We discuss the potential role of each of these experts in more detail below.
A labeling expert will provide a thorough review of product labels to provide an opinion as to whether the labeling of malic acid adheres to the relevant FDA regulations. In this context the expert will likely have to be familiar with the allegations of the natural versus synthetic versions of malic acid, as well as its use as a flavoring and other uses, which crosses over to the food formulation expert.
Food Formulation Expert
The food formulation expert should be familiar with the various uses of malic acid in food/supplement products. Despite the allegations being made in the lawsuits, malic acid is not exclusively used as a flavoring agent, and its role in a product is not necessarily used as specified in the flavoring regulation, which defines an artificial flavors as a “substance, the function of which is to impart flavor.”
According to FDA regulations, malic acid is recognized as GRAS and the relevant regulation states that malic acid has multiple uses in food including as a “flavor enhancer…flavoring agent and adjuvant…and pH control agent.” Further, malic acid is a dietary ingredient and appears to have been used in dietary supplements before October 15, 1994 (i.e., it is likely a grandfathered ingredient).
Since malic acid is an intermediate compound of the Krebs’ cycle – a series of biochemical reactions necessary to generate cellular energy in the human body – it is no surprise that it is an ingredient contained in many marketed dietary supplements. Indeed, malic acid and its ionized form malate have the subject of clinical studies to evaluate its effects on enhancing energy production among other endpoints.
Food Sensory Expert
In some instances, a food sensory expert may substantiate that the sensory experience of a consumer (e.g., as a result of natural flavorings) is not attributed to the malic acid, but from other more prominent ingredients.
As indicated previously, each malic acid case will likely have its own nuances, but we believe that the formation of a bullet-proof defense will begin with the retention of top-notch labeling and food formulation experts.
To initiate a discussion about your expert requirements or scientific litigation strategy, get in touch using the form below.
DISCUSS YOUR EXPERT RECRUITMENT NEEDS
ISS can help you build your ideal expert team. Get in touch by completing the form below and we will be in touch.