The Tricky World of Compliance

“I got into supplements and natural products because of my clinical herbalism training—I have a certified clinical herbalism background, I did a 3-year program, and I followed my passion for natural health into the products. I started making supplements in 2001 and I really grew up in the dietary supplement industry. I learned regulations from the inside out, such as GMPs for dietary supplements, labeling laws, and that type of thing.”

“About three years ago, I started my own consulting company, Supplement Advisory Group, which really focuses on the labeling and marketing side of natural products—in particular, dietary supplements.”

“A lot can go wrong when marketing a product. For example, a company can get an FDA warning letter by talking about an ingredient.”

“Let’s say you’re making a beverage or some type of hydration product, and maybe there’s an ingredient in there like turmeric or vitamin C. A lot of companies that are new to the nuances of conventional food and dietary supplement marketing don’t really know that if you talk about an ingredient or a study related to an ingredient, that’s really the same thing as putting it on the label.”

“So, in this hypothetical example, if a company was using turmeric or vitamin C but then was talking about how turmeric was studied for arthritis or maybe vitamin C is good for colds and flus, having that anywhere on your socials or on that website, even if you’re not linking to the product page, is the same as putting it on your label. It’s all an extension of the label.”

“There are a lot of penalties that can come from what they call ‘deceptive marketing.’ It’s the plaintiff attorneys and class action attorneys. They can sue for just about anything, such as putting ‘all natural,’ ‘no artificial colors,’ ‘no artificial preservatives,’ or ‘made in the USA’ on the label. These are all really low-hanging that are common plaintiff attorney lawsuits.”

“For a dietary supplement, the FDA allows structure function claims. For example, ‘calcium builds strong bones,’ or ‘antioxidants support cell integrity.’ But that crosses a line into the disease/health claims category, when they’re used to mitigate, treat, cure, or diagnose a disease.”

“A couple of rules for knowing if companies are crossing that line from a structure function claim into a disease claim would be:

- Anything ending in ‘-itis.’
- Words with ‘anti’ in the title, other than perhaps ‘antioxidants’ and ‘anti-aging.’
- Anything a drug is indicated for—for example, if Xanax was indicated for anxiety, “anxiety” would be the claim.
- Comparison to drugs, such as ‘Hey, this product works better than ibuprofen.’”

“The FDA in particular doesn’t want consumers to stop taking their needed medications. They don’t want natural product companies to go, ‘Hey our product works just as good or better [as medicines]’ because they’re concerned that a consumer will stop taking them and have some type of health crisis.”

“Many may not know that even putting a hashtag on a social media post can take an otherwise compliant post and make it non-compliant. For example, if a company uses #arthritis or #osteorthritis on a social ad for a turmeric product, they’ve elevated the risk of becoming non-compliant.”

“A good general rule is, if we wouldn’t put it on the label, we should be really careful making sure it doesn’t inadvertently slip by in any secondary piece of marketing.”

“Let’s say that a consumer writes something on a company’s social media wall, such as ‘Hey, this product worked great for my arthritis.’ Now if a company engages with that, including liking it, saying thanks, or using a smiley face emoji, that’s considered endorsing the testimonial and is therefore fair game for enforcement.”

“I don’t like to call out specific companies, but one example would be customer reviews. Let’s say a company takes a review off of Amazon or through a third-party widget and then copy-pastes that on their social media or highlights it in a banner ad. That’s considered marketing. That can lead to a warning letter, plaintiff-attorney lawsuits, etc.”

“Another way companies miss the mark is through influencers. Influencers need to disclose material connections if they’re paid by the brand. The FTC has some guidance on that. And the disclosure that they’re being paid has to be clear, conspicuous, and not buried in a bunch of hashtags.”

“It takes legal resources to respond to, it’s public record, it can get you dropped from your distributor or brand partner, and it leads to plaintiff attorney lawsuits. And, last but not least, it can really scare away investors and strategic alliances.”

“Every company needs to have substantiation for any claims it wants to make. In the world of enforcement, from a practical point of view, a statement about ‘helps with your insomnia’ or ‘helps with your arthritis’ is pretty high risk. But let’s say a company stuck with a more quality-of-life statement such as ‘makes you feel resilient after going to the gym’ or ‘helps you feel refreshed after waking up in the morning.’ These statements are not fully without risk, but they’re much lower risk.”

“From an FTC point of view, they want randomized clinical trials for product claims as part of their new health product compliance guides. Practically speaking, most big companies in the country build their substantiation dossiers not off of randomized randomized controlled clinical trials of products but on ingredients.”

“For example, ‘Here’s a study about vitamin C used at 1000mg helping with immune support.’ Okay, if we put vitamin C in the same form factor into our product and the study is well-powered, then perhaps that’s enough substantiation to make an immune support claim.”

“If there was a well-powered study done on 1000mg of vitamin C but I’m only using 500mg of vitamin C, then I’m not really fully utilizing the power of that study. I can add it into my substantiation dossier, but that’s probably not going to be enough to support an immune support claim.”