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A Big Potential Change In The FDA’s Enforcement Of Supplements

At a recent industry summit, the Food & Drug Administration made a forceful case for big change in how they treat supplements. Cara Welch, PhD, acting director of the FDA’s Office of Dietary Supplement Programs, recommended that the FDA create a registration database, and require all dietary supplement makers submit every product they sell in the U.S. to that database. The news was first reported by Nutritional Outlook and Natural Products Insider.

This action would bring dietary supplements in line with drugs, medical devices, cosmetics, and tobacco products, all of which require registration and listing of their products with the FDA.

The news fits with an overall recent increase in FDA enforcement. The Unwinder’s analysis of the FDA Warning Letter database shows a 37% increase in enforcement from 2019 to 2020, with 2021 on a similar pace.

Currently, dietary supplements are regulated as food. The FDA does not approve supplements based on their claims (for example, a claim to relieve stress). Regulation of supplements begins after they hit the market, based on adverse effect reports and general awareness.

New underlying substances, as in a new chemical compound, require notification to the FDA 75 days before entering the market. However, this is seldom abided or enforced.

The FDA does have labeling requirements for dietary supplements, as spelled out in their Code of Federal Regulations Title 21. A “Supplement Facts” panel must list all ingredients by weight, and disclose the presence of eight major allergens, such as milk, eggs, and tree nuts. All dietary supplements must also include the disclaimer about how “This statement has not been evaluated by the FDA…”. Small businesses are exempt from labeling requirements if their total sales are less than $50K/year, they sell less than 100K units, and have fewer than 100 employees.

The proposed registration requirement would include supplement facts labels, so the FDA could more easily target companies using problematic ingredients. Not listing would lead to penalties, and large retailers would fall in line and only sell supplements registered with the FDA.

Industry is mixed on this issue, with some supporting anything that legitimizes supplements, while others distrust the FDA’s acuity and intentions. Regardless, everyone selling consumable wellness products should keep an eye on this issue going forward.

Why You Can’t Believe Most Nutrition Studies

One of our favorite outsider-writers on the subject of health, nutrition, and wellness, Jeff Noobs, breaks down the problems with most nutrition-related headlines we see in the media.

That these headlines are problematic should be obvious. In our lifetimes, we’ve been told fat is good, and then bad, and then good again (remember margarine?). Sugar was never a concern, until it was. And seemingly every month another discovery of a life-preserving superfood is touted and then forgotten.

Why? A reliance on observational studies. Observational studies are what they sound like – researchers observe people’s behaviors, and then draw correlations to different outcomes. These studies are much easier to do than randomized controlled trials, which are the gold standard. In an RCT, a single intervention assigned, often blindly, to one group, while a similar group is given no intervention and serves as the “control”. RCT’s are often expensive, and, in some cases, unethical when dealing with questions of human health, life, and death.

Jeff details all the ways observational studies go wrong, from self-reporting bias, to differences between correlation and causation, and confounding variables. He also walks through the problems with reliance on biomarkers (like cholesterol levels).

The conclusion? “Half the studies you read about in the news are wrong”, and as a Stanford researcher estimates, only one-in-five of the well-designed ones are true.

This is an important piece to read to become an educated consumer of the science of nutrition and wellness. Read it here. It also relates to last week’s newsletter lead, about AlphaFold and the potential for virtual physiological humans to revolutionize the science of health in our lifetimes.

News & Notes – August 18, 2021

CNBC with a profile of Because Animals, a startup founded by a Stanford microbiologist that makes cat treats from lab-grown mouse meat.

The FDA denied Charlotte’s Web, the publicly-traded CBD-maker (whose Q2 revenue hit $24M), from allowing CBD products to be marketed as dietary supplements. Good analysis from Bloomberg here.

In other public company news, plant-based health foods and wellness products company SunOpta announced big Q2 earnings, with revenue growing 9.7% to $202M, driven by a 21% increase in their plant-based alternatives product lines.

🥛 Nice review of “NotCo’s AI-Generated Milk”. This company has really put on a press push since their big fundraise earlier this summer.

🧑🏻 Continuing a long-running trend of celebrities launching and investing in wellness brands, actor Adrian Grenier announces an investment in eco-friendly cleaning products company Blueland.

🥳 Tero Isokauppila, the founder of functional mushroom pioneer Four Sigmatic, with a guest post in Forbes exploring the return to in-person marketing. As sampling can be a huge way to drive consideration for new wellness products, particularly those unfamiliar to the average consumer, Tero’s thoughts on getting back to in-person provide a useful guide.

For those wellness product brands seeking to build a subscription-based business, new startup Upscribe, recently funded with $4m, may be a fit. TechCrunch has the scoop here.

☠️ For those unfamiliar, ConsumerLab does the hard, independent work of testing supplements and consumer products where the FDA doesn’t. They recently found unnaturally high levels of the toxin coumarin in a handful of cinnamon products. Read, subscribe, and be aware.

🧃 A #longread from Melinda Fakuade at Vox on how the intersection of wellness and consumer capitalism has created the overflowing, multi-color, ever-revolving beverage aisles in our stores. Many of The Unwinder’s community of brands (you!) mentioned.

🥔 Potato milk? Have you tried it? For or against? If you have no opinion, get one soon because potatoes just may be the “Next Big Milk.”

Social Growth Leaderboard

NotCo must be spending those fresh funding dollars at least in part on marketing, as they lap the field in Instagram Follower Growth for the period.

Outside of that, growth slowed down the last few weeks overall. We will see next time what back-to-school brings.

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