Some of the most popular new supplement delivery formats are also among the easiest to misclassify. As stakeholders invest greater resources to meet consumer demand for ritual-based or on-the-go products like bars, gummies or RTD shots, in some cases, these products reach the market before companies have fully assessed whether they meet the legal definition of a dietary supplement.
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), supplements must be taken by mouth and cannot be represented as a conventional food or a sole item of a meal. As brands ramp up R&D into alternative formats, applying those criteria is becoming more complicated, and mistakes can be difficult to correct once a product has hit retail shelves.
After launch? It may be too late
In the push to stand out in a crowded nutritional supplement and wellness product market, regulatory review does not always happen early in development, and that timing gap is one of the most common sources of risk.
“Most often novel delivery formats are introduced without knowing they do not comply, which can be a tricky risk to mitigate after launch,” Adams, a partner at Amin Wasserman Gurnani, LLP, told NutraIngredients.
Some formats, like inhalants such as vitamin-infused vapes or patches, raise immediate red flags and can “pose some of the biggest compliance risks,” she said. Other non-traditional delivery systems may still be compliant, like pouches, gummies and other candy-like formats, but could require special labeling considerations, she added.
‘Ingested’ remains strictly interpreted
Many delivery format questions ultimately come back to FDA’s interpretation of ingestion under the Federal Food, Drug, and Cosmetic Act, “which FDA interprets in its plain English meaning of being consumed orally,” Adams said.
That interpretation excludes a range of delivery systems that marketers and brands may label as dietary supplements, like topicals and other non-oral methods, but they “are not deemed ‘ingested’ under the FDCA and therefore do not meet the definition of being a dietary supplement,” she explained.
When companies attempt to market those formats as supplements anyway, enforcement typically follows a familiar path.
“FDA’s typical enforcement is to issue a Warning Letter, at which time a product faces the difficult choice of trying to pivot to somehow comply or face further action,” Adams said. “If there is a significant safety concern, FDA could explore seizures and recalls, as well as posting public warnings.”
Sublingual formats remain difficult to defend
Sublingual strips and fast-dissolve films are often described as oral products, but FDA has repeatedly rejected that characterization.
“FDA has consistently stated sublingual delivery is not ‘ingestion’ and declares such formats are neither dietary supplements nor foods, and instead are unapproved new drugs,” Adams said.
Even in cases where a product is ultimately swallowed, regulatory risk can become more pressing depending on how the product is described to consumers.
“The instructions for use and advertising of how the product works must be strictly reviewed and controlled to ensure a product is consumed and does not convey an intended use or benefits of sublingual administration,” she added.
How beverages can blur the line
Liquid supplements remain a popular choice for many wellness consumers, but they are also among the formats most likely to draw regulatory scrutiny as brands borrow cues from conventional beverages.
“Fortunately, FDA has a very helpful guidance document setting forth factors they consider when determining ‘beverage’ vs. ‘liquid supplement,’” Adams said.
While there is not a single determining factor, she noted, some tend to raise more questions than others. Critical factors include “the size of the product, the name of the product as a supplement or something more beverage-y like ‘juice’ or ‘drink,’ and the advertising and positioning as something similar to a conventional beverage,” she explained.
Food-like formats come into focus
Formats that closely resemble conventional foods continue to straddle the regulatory line, particularly as brands experiment with novel or indulgence-driven concepts. However, “food-mimicking can be successfully navigated, especially in the bar format and gummy arena, with appropriate label and advertising considerations,” Adams said.
Clear dosage communication and safety controls are central to that assessment.
“Most critical will be conveying dosage size and ensuring safety such as taking steps to prevent inadvertent overconsumption or consumption by non-intended audiences such as children,” she added.
Some formats, however, are difficult to justify regardless of the labeling strategy, as “items that are well and truly foods will be a regulatory liability.” For example, she illustrated, “FDA is on record that a stick of butter cannot be labeled as a supplement.”
Understanding enforcement action signals
Recent FDA activity suggests that products closely resembling familiar foods remain under scrutiny. For example, classic candy formats like chocolate bars or snacks like cookies “seem to be getting a little more attention,” Adams said, emphasizing “that formats that consumers readily perceive as ‘food’ are likely over the line.”
As formal guidance struggles to keep up with delivery format innovation, Adams said regulatory review is becoming more and more influential in stakeholders’ R&D processes.
“Compliance should be an initial discussion, not an afterthought,” she recommended, as a “novel format may have marketability issues if it poses significant regulatory risk, and early compliance conversations can benefit innovation efforts.”
While she does not expect a sharp increase in enforcement activity, Adams added that supplements in conventional food formats will likely continue to be the target, reinforcing that format choice itself is becoming a regulatory filter.
