Compliance: is your new product a food or supplement?Compliance: is your new product a food or supplement?
When deciding whether a new product will launch as a food or supplement, four regulatory areas to consider are identification, manufacturing, claims and composition.
August 21, 2018
One of the more troubling aspects of modern life is the time it takes. On-the-go lives don’t have enough time. Consumers are challenged to obtain meaningful nutrition in the most convenient way possible, which leads to increasing market demand. Companies providing portable nutrition products to fill these needs are often challenged by the regulatory world regarding whether a new product is considered a food or dietary supplement.
The four basic areas of regulatory concern are identification, manufacturing, claims and composition.
The first challenge is in the item’s identification. Simply put, what type of product is it? Is it a dietary supplement? How does one know? Well, if it looks like a duck…. But, that is not the only qualifier. The physical presentation of a product may make the determination. No matter how a product is labelled or promoted, a piece of compressed and formed goodness that is intended to be eaten in several bites is a food.
If the volume of a liquid nutrition product is enough, FDA’s interpretation of what qualifies as a beverage is tied to the amount of hydration provided. Rest assured, the appearance of the product in physical form will in part determine the product category.
If options remain for the identification of the product despite physical form, brands still need to pick a lane. Presenting the identification of a product as a dietary supplement and then describing it elsewhere in the labeling as a “nutritious beverage” or “healthy snack” will undermine the identification and render the product a misbranded food. This applies to every piece of labeling associated with the product. Tie a product to food descriptors too often in the labeling, and a brand will have rendered a labeled dietary supplement a misbranded food. Once the determination is made, the identification of the product must not alter in promotional material.
More challenges may arise related to manufacturing. If the product is a food in conventional form, regulations concerning manufacture are found within Parts 110 and 117 of the regulations. Dietary supplements must follow a different set of requirements for manufacture: Part 111 of the regulations. There are important, significant and meaningful differences. This becomes especially important when the product is provided by a contract manufacturer that isn’t aware of the Part 111 requirements. A contract manufacturer’s compliance is mandatory for the finished product brand’s compliance. Failure to conform to proper regulations renders the product adulterated. Therefore, the first challenge, identification, puts emphasis on the second challenge, manufacturing.
The next domino to fall in the regulatory challenge chain involves product claims. The automatic focus of claims in the supplement category is the use of structure/function (S/F) claims. Such claims may also be made for foods with one caveat: S/F claims made for food products may only be based on the nutritive value of the food. This is interpreted as relating only to those nutrients that have an established recommended daily intake (RDI) or daily reference value (DRV). If the benefits derived are from a nutrient that does not have one of those acronyms, the claim is not allowed.
It seems as though composition should be straightforward; however, if the product is a food, the whole array of food additive regulations applies to every ingredient in the product. Many of the ingredients used in dietary supplements might not be acceptable food additives. Brands cannot simply take the same components featured in dietary supplements and present them in food form without further thought. Evaluation of every ingredient in the food product must be performed to avoid creating a product that is adulterated due to an unapproved food additive, or the inappropriate use or level of food additive.
The first decisions made for on-the-go forms of nutrition (the product’s identification) affect all the regulatory burden and requirements that follow. Formula design and evaluation are critical to the first assurance of compliance.
As chief operating officer, Jim Lassiter oversees all consulting operations at Ingredient Identity (ingredientidentity.com). He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma, Irwin Naturals, Chromadex, the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN). A respected author and speaker, Lassiter has served on numerous industry and trade boards.
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