From Lab to Label: The Scientification of Consumer Brands
Episode #61: What Your Warning Letter Is Really Telling You with Steven Shapiro
Got a warning letter? Don't ignore it. And don't assume it's the end of the road either. In this episode, Susanne sits down with Steven Shapiro, a food and drug regulatory attorney with more than 30 years of experience advising supplement, food, OTC, and cosmetic brands on labels, claims, and enforcement. Steven shares how his early work on the black currant oil cases helped lead to DSHEA in 1994, and how the industry has grown from a handful of family-owned companies into a multi-billion dollar market. Together, they explore who sends warning letters, where the line falls between supplement and drug claims, and what brands actually need to substantiate what they say. What's covered in this episode: How FDA, FTC, and NAD warning letters differ, and why ignoring the NAD can bring federal regulators to your door Why own-label distributors are responsible for GMP compliance, even with a certified contract manufacturer How to tell a structure-function claim from a disease claim, and why that line keeps shifting When customer reviews and social media comments become the brand's legal responsibility Why claims like "natural" and "zero sugar" are a magnet for consumer class actions What "competent and reliable scientific evidence" really means, and what a pilot study can and can't support Tune in to hear Steven's perspective on why testimonials aren't substantiation, how to build a case from the full body of science, and what every startup should put in place before their first product hits the shelf. About USU Law Ullman, Shapiro & Ullman, LLP is a New York law firm focused on food, drug, and cosmetic law. They help supplement and natural products brands, from startups to established companies, with FDA and FTC compliance, label and advertising claims, and enforcement. They're known for clear, fast answers, often a single email instead of a 15-page memo. About Rivkin Radler Rivkin Radler is a full-service law firm with six offices and 250 lawyers, consistently ranked among New York's 50 largest firms. Many of their attorneys are recognized by Best Lawyers and Super Lawyers, and some clients have trusted the firm for more than 30 years. Steven Shapiro and Marc Ullman serve as of counsel, giving their clients access to the firm's full range of services. Get in Touch Visit USU Law’s website: https://www.usulaw.com/ Visit Rivkin Radler’s website: https://www.rivkinradler.com/ Interested in a clinical trial for your health or wellness brand? Shoot us an email at hello@citruslabs.com ; we would love to learn more about your company! To learn more about Citruslabs, visit us at citruslabs.com You can also send us your feedback and questions. Email us at hello@citruslabs.com
