In the beginning, there were tablets. And, they were good…for the most part. But for users who found them unpalatable, difficult to swallow, or just-plain boring, they left a lot to be desired. So, dietary supplement developers said, “Let there be better delivery systems.” And, then there were capsules, gel caps, and soft gels, which considerably improved upon the basic tablet.
Then developers said, “Let there be shots, sprinkles, chews, and gummies,” and these options were even more convenient, appealing, and innovative than what came before. So now that everything from nutrient nanoemulsions to liposomal blends is emerging from R&D labs, we may be witnessing the most exciting delivery advances the dietary supplement space has ever seen.
But: Are they truly supplements?
That’s the question facing industry and regulators as new nutrition platforms push the edges of science, creativity—and the law. How far do those borders reach? Vincent Tricarico, vice president of contract manufacturing at NutraScience Labs (Farmingdale, NY), believes, “We’re still in the very early stages of determining where these new formats end up in terms of regulation.”
And while FDA might counter that we know exactly where the regulations stand, thank you very much, we can all agree that the goal, as Tricarico says, “is to keep the public safe.” So, as we chart this brave new world of supplement delivery systems, caution may be the first commandment.
Despite all the innovations in delivery-system design, formats such as classic capsules, powders, softgels, and tablets—as well as gummies, liquids, and chewables—“remain the most popular supplement delivery systems by far,” Tricarico says.
Missy Lowery, MSc, senior manager of marketing at Capsugel (Morristown, NJ), concurs, noting that all generations—“Millennials, GenXers, Boomers, matures”—still gravitate toward traditional delivery formats. More specifically, she says, 42% of supplement users prefer capsules, while 41% prefer tablets, according to the most recent 2015 Supplements Over-the-Counter Rx Data (SORD) study from NMI.1
But, Mona Liu, brand supervisor of marketing at Sirio Pharma Co., Ltd. (Shanghai, China), says, “While these delivery systems have been successful in the past, they’re facing challenges from innovative delivery systems of the future.”
Why We Innovate
Such challenges are understandable. “Innovation in delivery systems is critical to helping certain individuals meet their needs, preferences, and limitations,” says Douglas “Duffy” MacKay, ND, senior vice president of scientific and regulatory affairs at the Council for Responsible Nutrition (CRN; Washington, DC). Older users can have difficulty swallowing pills; children simply may not like them. Consumers can tire of the same-old supplement vehicles. Even psychology plays a part, as “the traditional tablet and softgel can remind people of medicines or drugs,” Liu adds.
Innovation does more than satisfy consumers, however. It also feeds supplement industry growth. Of course, discovery and development of new supplement ingredients—and new uses for them—account for the bulk of that growth. Differentiating a product via novel delivery is a reasonable means of fending off competition, at least for a while.
Says MacKay, “There are all sorts of reasons to explore different formulas and ingredients in everything from a gummy to a tablet to a capsule to a liquid to a chewable to a wafer”—all of which, he adds, are “well within our regulatory areas.” It’s when exploration starts moving outside those areas that alarms may sound.
No Direction Home
To an industry as captivated by scientific progress as ours, limiting the scope of delivery-system invention can feel a bit like taking away the punchbowl. “There’s the desire to be creative and innovative and to think outside the box, which is such an exciting thing to be part of,” MacKay states. But the flipside of that excitement, he says, is “the tension between the category and the limitations it presents based on the regulations.”
And the “number-one limitation” that the Dietary Supplement Health and Education Act of 1994 imposes is its narrow definition of a dietary supplement: a substance administered orally, swallowed and absorbed through the gastrointestinal tract. “You start getting into inhalables, transdermal patches, nasal sprays, vapes,” MacKay says, “and these just don’t have a home inside of dietary supplements. They can’t change the supplement laws. These just are not dietary supplements.”
Crossing the Line
Consider sublingual products. Vitamin B12 is a prime example of a nutrient for which sublingual administration—wherein drops of the vitamin placed under the tongue are absorbed through blood vessels—is “convenient and important,” MacKay say. Many of the enzymes that help us absorb B12 through the gut weaken and diminish with age.
And though “you can still deliver B12 in a dropper bottle, make it with dietary supplement GMPs, and label it as a supplement,” MacKay continues, “you cannot tell the customer that it’s intended to be absorbed through the blood vessels under the tongue” as opposed to the gut. Only doctors can do that—say, as a treatment for megaloblastic anemia. “So, the question for FDA becomes, ‘Is that appropriate for supplementation, or is that more of a clinical use?’” MacKay says. “And their answer would be clinical. It makes sense from a public health/public policy balance.”
Even wildly popular functional foods can tread into dicey regulatory territory. Several times recently, FDA has warned marketers of melatonin-containing brownies, beverages, and other foods that because their products are conventional foods rather than supplements, the presence of melatonin—an unapproved additive without GRAS status for food use—in their formulations renders them adulterated. Here, too, MacKay thinks “if you peel back the layers of that onion,” FDA’s move “does make some sense.” While an ingredient like melatonin may be “appropriate to put into a dietary supplement labeled, ‘Take one capsule before bedtime, it’s not appropriate just to throw it into some chocolate milk.”
- NMI, “2015 Global Supplements/OTC/Rx Consumer Research Study.” http://www.nmisolutions.com/opt/studies/NMI-2015-Global-SORD-Research-St.... Accessed October 4, 2017.