Launched last year by industry veteran Asa Waldstein, the A.I.-powered keyword scanning and reporting program is a natural evolution of his work as principal of Boulder, CO-based boutique regulatory consulting firm Supplement Advisory Group, which advises clients on U.S. supplement labeling and online marketing compliance. Waldstein also publishes the Warning Letter Wednesdays newsletter, a weekly exploration of U.S. Food and Drug Administration warning letters and enforcement trends.
NIU: What gap did you identify in the market with Apex Compliance?
AW: I’ve dedicated 22 years of my professional life to the supplement industry and love it. However, when it comes to technology, supplements fall behind other industries.
I initially went looking for a program for my consulting company Supplement Advisory Group that had customized web searching and content review capabilities. When I discovered none existed, I built my own program. Then, several clients and colleagues started asking to license the product, and I went back to the drawing board and developed the robust SaaS platform that Apex Compliance is today.
Companies continue to receive warning letters and lawsuits for “forgotten” content on their websites and videos. Website reviews that used to take weeks and were still incomplete can now be done in a matter of minutes. Apex Compliance then delivers a comprehensive report showing where risky marketing statements occur, their risk rating, alternative suggestions and more.
Also, reviewing content such as blogs or social posts before publishing is a laborious and time-consuming process. Apex Compliance streamlines the review process and decreases the backlog many regulatory and legal teams face, therefore helping content to be published faster and freeing up teams to focus on other regulatory or marketing needs.
NIU: What went into building the program (what fed the AI, how does it factor in variances, how customizable, etc.)? How big is the database of trigger words/phrases?
AW: The database, which comes preloaded with every Apex Compliance subscription, contains over 100 high-risk words and phrases and some possible lower-risk alternative suggestions. The program, however, is fully customizable, allowing users to add keywords that may apply to their company, such as "no artificial flavors", "increases immunity" or disease words like "osteoporosis".
The Apex Compliance AI is trained on compliance principles such as the FDA preamble, warning letter enforcement, litigation trends and my 20+ years of regulatory experience. The AI features that help users develop possible alternative and compliant language are fully customizable and can easily be directed from simple prompts.
NIU: How do companies sign up?
AW: Apex Compliance is a cloud-based software that can be accessed from anywhere, so no program downloading is needed. Apex is a monthly service with steep discounts offered for annual and multiple company subscriptions. All reports and content review edits are easily downloadable, and each subscription comes with its unique personalized dashboard.
NIU: What are some of the biggest triggers/common pitfalls that you have identified across marketing materials to date?
AW: Even the best companies who now have robust regulatory review processes are surprised to see the regulatory "landmines" that Apex Compliance finds. These potentially forgotten claims usually occur in old blogs and videos, but in the eyes of the authorities, even very old content is considered active marketing and is, therefore, fair game for enforcement.
NIU: How has Apex Compliance been received since launch? How many companies have signed on?
AW: I am very grateful to report that Apex Compliance has several dozen subscribers and is very well-received, as exemplified by our nearly non-existent churn rate. We’ve seen most companies who try the program continue to happily renew their subscription frequently.
NIU: How does the program continue to evolve to keep up with the ever-changing regulatory landscape? What is next for Apex Compliance?
AW: We will continue to share updated keyword lists with subscribers as enforcement trends change. For example, I am preparing a "Green and Eco Claims" list that includes many sustainability-related trigger words, possible alternative verbiage and links to helpful information like articles and videos by industry experts on this topic.
Apex Compliance will add features to help companies stay ahead of the regulatory curve, such as the ability to make Amazon marketing compliance checks easier, scan more social media platforms and help companies comply with influencer compliance regulations.
NIU: Where do you see the most marketing compliance risk for companies in the sports and active nutrition category?
AW: FDA, FTC and plaintiff attorneys pay close attention to this space, and product labeling, product page statements and claims on social media continue to be called out. Reducing the risk of agency action and lawsuits helps companies keep their focus on developing efficacious products backed by data.
Also, plaintiff attorneys love to sue companies for making implied clinically proven claims, so even if companies have great data, making these types of statements often leads to scrutiny. Since Apex Compliance is customizable, companies may choose to use the program to flag "clinically proven" types of claims and suggest lower-risk alternatives.
NIU: What Apex achievement/particular innovation are you most proud of to date?
AW: The testimonials section of Apexcomplianceprogram.com continues to grow with stories about how extremely large, medium-sized and very small brands all find ways to use Apex Compliance to help their companies. Seeing how this program is helpful to all corners of the industry is the very best feeling! Another thing I am proud of is when people first see Apex Compliance, and they say: "This is going to save us so much time."
Apex Compliance has proprietary IP that is close to moving to a non-provisional patent protection. This lengthy process has been a journey, but our friends at Amin Talati Wasserman have been fabulous to work with for our IP protection needs.
I am also very honored and grateful to be recognized by NutraIngredients-USA as a Start-up Star. So much sweat, tears, stress and love has gone into building Apex Compliance. Winning this achievement helps validate the enormous amount of time and investment that has gone into making this product. We are very lucky to join this star-studded group of winners.
Sports & Active Nutrition Summit
The Sports & Active Nutrition Summit will be held in San Diego from Feb. 12-14. The Start-up Stars will present their companies, and industry leaders will discuss topics including the state of the market, the modern sports nutrition consumer, women’s health, disruptive tech, the microbiome, recovery and adaptation, regulatory developments and more. For more information and to register, please visit the Sports & Active Nutrition Summit-USA page.