As the saying goes, ‘The best way to predict the future is to study the past.’ When it comes to 2024 regulatory outlook, there is no better prognosticator than Asa Waldstein, industry veteran, Founder and CEO of Apex Compliance, and author of Warning Letter Wednesday, the dietary supplements industry go-to resource for an exploration of FDA warning letters and enforcement trends. We had a chance to catch up with Asa to discuss what the industry can anticipate for 2024 regulatory policy based on 2023 trends. Here’s what we learned.
Learning #1: Let the Amazon FDA warning letters of 2023 be a wake-up call for distributors
“Amazon received three FDA warning letters in 2023 for selling non-compliant products on their platform. Amazon is a distributor, so expect the FDA to put more distributors’ feet to the fire. If you are a distributor or an online marketplace, you are ultimately responsible for the claims made on your website. While I do expect more enforcement letters for Amazon, I also expect more warning letters to other distributors,” said Asa. He went on to clarify that, “In the warning letters, the FDA intentionally goes above and beyond to clarify that Amazon actually handles the products and is therefore responsible. I’m uncertain if the FDA is discerning the difference between handling versus a 3PL or fulfillment. It will be interesting to see how the FDA enforces distributor requirements if handling or not directly handling a product.”
Learning #2: The food safety warning letters of 2023 are forecasting more robust FDA audits in 2024.
“In 2023, there was a lot of cGMP enforcement related to finished product specifications composition testing. Additionally, there were 36 Food Safety Modernization Act (FSMA-CFR 117) related warning letters in 2023 and this shows that FDA is getting more serious about FSMA compliance,” said Asa. “The FDA always gives some leeway when new strong regulations are enacted. There is a bit of a runway, but it is clear that this runway is ending so expect a lot more food safety warning letters in 2024. For example, in previous years, if an unannounced FDA audit took place, the auditors would perform a cGMP CFR 111 or a FSMA 117 inspection. More recently, I am hearing that they are bundling and doing both. This shows that the FDA inspectors are getting more trained up on FSMA food safety and cGMP requirements.”
Learning #3: When it comes to CBD and Delta-8 federal enforcement, expect the proverbial can to continue to be kicked in 2024.
“In 2023, I predicted more CBD & Delta-8 enforcement,” said Asa. “There were only 15 CBD & Delta-8 enforcement letters in 2023 as opposed to 34 in the previous year. When reflecting on the “why,” I speculate that this is because there are less companies in the space and therefore less claims, and therefore less of an opportunity to run afoul with disease claims. Many people that came into the category within the past several years didn’t know about the compliance, DSHEA, and making aggressive claims, and these people have since moved on.” While Asa is not expecting federal policy changes in 2024, he remains cautiously optimistic. “In lieu of federal policy changes, states are dictating their own requirements for product registration. The continued patchwork quilt of compliance makes it difficult for companies to operate in the cannabinoid space.” In the absence of formal federal policy, Asa offers brands this advice: “As a default, act how you want to be regulated. If you’re acting like a dietary supplement, make sure to comply with dietary supplement manufacturing, labeling, marketing, and regulations.”
Learning #4: The next chapter in the FTC Health Product Guidance and notice of penalty offenses saga remains uncertain in 2024.
“We can’t talk about 2023 without talking about the notice of penalty offenses from the FTC to about 670 supplement and health products companies in April 2023. This was a big shot across the bow to the dietary supplement industry basically saying that the FTC is going to take substantiation requirements very seriously as related to their Health Products Guidance document,” said Asa. “So far there hasn’t been any action but the FTC Health Products Guidance document and subsequent notice of penalty offenses did put substantiation top of mind for the industry. While we haven’t seen any punitive action so far, it’s uncertain if we will see another round of penalty offenses or if the FTC will follow through on the penalty offense letters.”
Learning #5: Expect the influencer community scrutiny and enforcement to continue in 2024.
“In November 2023, the FTC sent 12 warning letters to influencers and trade groups touting sugar alternatives on social platforms. This was an interesting time writing my Warning Letter Wednesdays because it was the first time that the FTC had enforced their mandatory disclosure guidelines,” said Asa. “Now the influencer community is watching and seeing if there is more enforcement coming.” Asa added that, “Another part about the FTC notice of penalty offenses in addition to substantiation was misrepresenting product reviews. So we are beginning to see different facets of FTC holding brands and influencers accountable.”
Asa concluded with empathy for the industry, “there has never been a more difficult time than now to manufacture or market dietary supplements. The industry is being hit with FDA, FTC, State Attorney Generals, Plaintiff Attorneys, and now Government Accountability Office, it’s kind of non-stop. Radicle Science helps make substantiation requirements so much more approachable by democratizing access to clinical trials for brands of all sizes.”