The time has come to ask a very personal question: What line of business are you in? Is this a consumer packaged goods industry? A niche of the food sector? An aspirational marketing enterprise? A get-rich-quick endeavor for intrepid investors? A collection of mom-and-pop companies just looking to stay afloat as small businesses?
Or none of the above?
If you ask your consumers, the answer is: Dietary supplements are in the healthcare business. People purchase our products with the expectation that they will help keep them healthy. Consumers buy and use our products to maintain and preserve good health, just like they purchase pharmaceuticals to treat disease and regain good health. Every time a consumer opens a bottle, pouch or blister pack and puts one of our products in their mouth, we take our place as providers of healthcare—part of a continuum of goods and services that span from prevention to recovery. And, when you stop to think about it, that level of trust demands a level of accountability that surpasses the other characterizations of who we are. More than candy and snack foods, more than beauty products, even more than organics and health food, we are healthcare.
Getting it right
Along with that comes a level of responsibility that, as this issue of the NBJ illustrates, too many companies have failed to live up to. The warning letters issued by FDA over the past eight years reveal some disturbing patterns, too. CRN’s database of FDA warning letters demonstrates various elements of the problem. In 2015 alone, FDA issued 80 warning letters to manufacturers and marketers of dietary supplements. Fifty-three of them—well over half—were sent to companies for products that FDA called “misbranded.” These were products (and most of the warning letters listed numerous products) that were defiantly marketed as treating or curing diseases despite the expressed prohibition on such claims in DSHEA.
Another trend revealed from the warning letters is the growing interest FDA has in enforcing the new dietary ingredient (NDI) provisions of DSHEA. After years of not even mentioning NDI requirements in their letters, FDA issued 11 warning letters in 2012, calling out firms for marketing new dietary ingredients without a notification. FDA went fairly silent again for the next two years with only a few warnings each year, but came back in 2015 with 21 warning letters, mostly to companies marketing DMBA and BMPEA. The ill-conceived notion of bringing new ingredients to market without providing FDA with a reasonable expectation of their safety is definitely attracting enforcement attention, even without a revised NDI guidance from the agency.
Making it right
Perhaps one bright trend is that the number of warning letters issued for Good Manufacturing Practices (GMP) violations is declining despite increased inspections. Since 2013, the number of follow-up letters each year for significant violations of the GMP regulations has been: 43 in 2013, 37 in 2014 and 24 in 2015. If the warning letters serve as an indication of compliance, perhaps the industry is starting to take GMPs seriously.
What is concerning is the trend of increased warnings to tiny pop-up companies who use third-party contractors to make their products, doing so with little knowledge of what they are putting their name on. The past year has seen unprecedented attention from FDA on these small companies for their apparent disregard of GMP requirements. The law is clear: if your name is on the product, you must know how your product is made and what’s inside. The deflection, “my contract manufacturer should know; go ask him,” clearly is not cutting it.
Nor should it. We are in the healthcare business, remember? That demands accountability to not promise consumers results that you can’t deliver and to not make claims that are patently illegal. It demands that ingredient developers play by the established rules and notify FDA when they bring these new ingredients to market. And any company—no matter how big or small—who puts its name on a dietary supplement product should know exactly how its product is made down to the specifications, understanding the formulation, and how the product’s actual manufacturer assures that every bottle is of consistent high quality.
Doing it right
At CRN, we are encouraging our members to embrace their “healthcare” status. We recently announced we are requiring our members to provide their labels to the Office of Dietary Supplements Label Database. It’s only one step toward greater transparency, but we are accepting our responsibility to allow regulators and researchers alike to see the expanse of the industry and compare products. We are expanding our collection of voluntary guidelines with new requirements for pre-natal supplements, formulation and labeling of melatonin, and probiotics. We’re celebrating the 10th anniversary of our advertising review partnership with the National Advertising Division (NAD) and helping our members understand the intricacies of GMP compliance along with even higher voluntary standards of supply chain integrity.
As providers of healthcare, we owe consumers as much. Everyone is watching our industry: skeptical news media, Congress, state AGs, consumer watchdogs.
Years ago, C.S. Lewis was famously quoted as saying integrity is the measure of what you do when no one is watching. That’s still true, but today, it is a rare moment indeed when no one is watching.
Whether everyone is watching or not, our industry needs to demonstrate integrity. Remember, we are providing healthcare.