2018 was the year that CBD went mainstream, even though the FDA’s position is that it is not permitted as an ingredient in food and dietary supplements.
While the Hemp Farming Act, as part of the 2018 Farm Bill, removes one hurdle, the FDA and its exclusion principle still exists. In December, FDA Commissioner Gottleib issued this very important statement: “While products containing cannabis and cannabis-derived compounds remain subject to the FDA’s authorities and requirements, there are pathways available for those who seek to lawfully introduce these products into interstate commerce. The FDA will continue to take steps to make the pathways for the lawful marketing of these products more efficient.
“… In addition, pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement. Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process.”
If FDA does indeed permit CBD for use in food and supplements, and one would assume that an NDI or GRAS notification would be needed first, then it’s game on. Then we just need to figure out what these compounds really do, and what benefit claims can be made that are legitimate structure-function claims!
2. Probiotics, prebiotics and the microbiome
According to Euromonitor, probiotics are the fastest growing category of dietary supplements, and public interest in the microbiome is exploding. This opens up further opportunities for prebiotics, which are gradually establishing themselves in the public consciousness.
The timing has never been more critical to remain vigilant around the quality of the products and the claims that are being made, and it’s good to know that organizations such as IPA and ISAPP are working hard to educate both the industry and consumers. But the success of the category will also drive increased scrutiny in the mainstream media and from industry critics… which leads us to…
3. Negative media and industry critics
Probiotics were just one area of the industry that garnered some big headlines in 2018 questioning their efficacy, and we anticipate that continuing. As the industry continues to thrive, and consumers increasingly look to these products in the face of burgeoning healthcare costs, questions will continue to be asked. Some of the criticism will be totally justified – we all know there are problems and challenges along the manufacturing supply chain.
Transparency will be critical to counter this, and efforts have significantly improved in recent years, and Steve Tave at FDA has said that “many firms are, for the most part, getting it right.” But you can always do more.
There is also the effect of third-party certifications regarding social responsibility (transparency of supply chain, environmental impact, etc.), and how these could make or break a brand more than ever before (in 2018 several big supplement companies got certified B Corp, for example). Therefore, companies should get more creative in communicating social and environmental commitments.
4. DSHEA at 25
A quarter of a century – that’s how old the Dietary Supplement Health and Education Act is. The industry’s two main champions – Sen Orrin Hatch and Sen Tom Harkin – are no longer in Congress to fight the good fight, and Scott Gottlieb recently announced the formation of a DS Working Group to explore potential new legislation.
Whatever your views on Eric Schneiderman, his actions in New York have changed the industry, and conversations that were taboo just 6 years ago are now occurring in public forums. Gottlieb’s proposed working group would have been met by howls of resistance not that long ago, but today’s industry is different and stakeholders are cautiously receptive.
It will be fascinating to see what comes out of that…
5. Science, science, science
2019 will also see the completion and publication of some important clinical trials, from the Ranger Resilience and Improved Performance on Phospholipid Bound Omega-3's (RRIPP-3) using krill oil (completed June 2018, but not yet published), to the PRO Health (Probiotic for Oral Health) Study at UC, Davis, and a study of curcumin on the gut microbiota in children with IBS.
In fact, ClinicalTrials.gov lists over 800 intervention studies using a dietary supplement with a primary completion date in 2019. Not all will have positive results, many may be null, but it is vital that the industry continues to invest in these and effectively and accurately communicate the results to consumers.
To read Part 2, please click HERE.