Innovation Outpacing Regulation: A Compliance Wake-Up Call for the Nutra Industry

As novel supplement delivery formats such as gummies, bars, RTD shots, pouches, strips, and liquid sachets proliferate, the nutraceutical industry is entering a regulatory gray zone where innovation is increasingly outpacing compliance. Legal experts caution that many of these formats risk falling outside the legal definition of a dietary supplement under DSHEA, particularly when products resemble conventional foods, beverages, or drug-like delivery systems such as patches, inhalants, or sublingual strips. Without early regulatory vetting, brands face heightened risks of FDA enforcement, misclassification, warning letters, or forced reformulation. The message to the nutra industry is clear: compliance cannot be an afterthought. Regulatory strategy must be embedded at the R&D stage to ensure that exciting new delivery systems do not undermine product viability, brand credibility, or long-term market access.

Source : https://www.nutraingredients.com/Article/2026/01/15/legal-expert-compliance-challenges-rise-with-novel-supplement-delivery-formats/