GxP Lifeline
Using the Newly-Approved Dietary Fibers in Supplements
Eating habits in the developed world aren’t exactly the healthiest. That’s not a shocking piece of news. One of the side effects of the typical modern diet is that certain nutrients tend to get left out. This means that many adults aren’t getting enough fiber. For the body to run smoothly, adults need anywhere from 21-38 grams of fiber daily, depending on age and gender. Getting that amount of fiber normalizes your bowel movements, lowers cholesterol and can help control blood sugar levels1. Not getting enough fiber is a particular problem for seniors, most of whom deal with constipation to a certain extent as they age.
Fortunately, supplement makers are happy to provide ways to get an extra boost of fiber. Whether you prefer to pop a pill or mix some powder into a glass of water, nutraceutical companies have plenty of ways to up your fiber intake. And if you’re going to take a supplement, you want to make sure that you’re getting a good amount of fiber with it. For years, the U.S. Food and Drug Administration (FDA) had no specific rules on what could be considered dietary fiber and included on food and supplement labels, but that changed in 2016 and has recently been updated.
Broadening the Definition of Fiber
The FDA’s technical definition of dietary fiber from 21 CFR Part 101 is “non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) determined…to have physiological effects that are beneficial to human health.” Initially, the FDA provided seven non-digestible carbohydrates that met this definition: 1) beta-glucan soluble fiber, 2) psyllium husk, 3) cellulose, 4) guar gum, 5) pectin, 6) locust bean gum, and 7) hydroxypropyl methylcellulose.
The seven above-mentioned sources were never meant to be a complete list. With the proper evidence, the FDA was always willing to consider new carbs. According to FDA Commissioner Scott Gottlieb, M.D., “Our expectation is that we will continue to evaluate additional dietary fibers on a rolling basis, and we expect that additional fibers may be recognized in the future.”2 If a supplement maker has a non-digestible carbohydrate that meets the FDA’s definition, they can submit a citizen petition showing scientific evidence that it has a beneficial effect on human health.
After receiving citizen petitions, reviewing comments the Agency has received and evaluating the scientific data, the FDA decided to add eight new non-digestible carbohydrates to the list of sources of dietary fiber. These include:
- Mixed plant cell wall fibers
- Arabinoxylan
- Alginate
- Inulin and inulin-type fructans
- High amylose starch
- Galactooligosaccharide
- Polydextrose
- Resistant maltodextrin/dextrin
It’s worth noting that plant cell wall fibers include a number of non-digestible carbohydrates, such as sugar cane fiber and oat hull fiber, among others.3
Jumping On the Fiber Bandwagon
Fiber isn’t exactly an exciting supplement category. It’s not like turmeric or glucosamine or coQ10. Fiber supplements have been around for decades, there are dozens on the market, and they’re not “trendy.” But there are some categories of supplements that will always be in demand. Folic acid isn’t trendy either, but as long as there are women who want to get pregnant, there will be a need for folic acid supplements. Similarly, as long as there are people with digestive woes, there will always be a need for fiber supplements, and that need is likely going to increase because of baby boomers.
While millennials are either catching up to or surpassing baby boomers in numbers (depending on what source you read), boomers are a huge market and are entering the time of their lives when health decreases and the number of medications increases. Both over-the-counter and prescription drugs can cause constipation, as can certain diseases associated with aging, such as dementia and multiple sclerosis. And what’s a great, all-natural way to counteract constipation? Fiber.
One of the problems with fiber supplements also presents an opportunity. Anyone who’s ever had to swallow a glass of Metamucil can tell you that the taste leaves something to be desired. And that’s hardly unique to one brand. Fiber, like protein, has a unique taste and requires masking for a product to taste good. By experimenting with different fibers, nutraceutical companies can develop formulas that taste good or they can try out different delivery forms. Of course, if a company has problems in its processes or they’re too disjointed to be effective, a new product isn’t going to help any.
Don’t Let Quality Issues Hinder Development
Before developing new products or updating formulas for existing ones, companies should take a good look at how they handle the development process and how they ensure high quality in their supplements. If there are inefficiencies, bottlenecks or communication problems, finding the root cause of those issues and solving those problems first will allow for smoother product development and manufacturing in the future. One of the best ways to identify, correct and prevent recurrence of these kinds of problems is by implementing an electronic quality management system (QMS) that limits the probability and impact of human error.
Even with the best QMS in place, no product is ever perfect, and customers are quick to point this out. Aside from the fact that it’s required by the FDA, tracking customer complaints is a useful practice for nutraceutical companies. Since taste is a hurdle for fiber supplements, using data collected from customer complaints can be used to determine how well the company is tackling the problem. A sophisticated QMS can tell you if customers are dissatisfied with the taste, texture or performance of the supplement, allowing you to quickly solve the problem before it escalates.
Once you have all your quality ducks in a row, you can begin to develop a fiber supplement that uses these newly-approved fibers, increasing the amount of dietary fiber in your supplements and making a more effective product that will especially appeal to seniors. Get the taste down and you’ll have a product that will be a breath of fresh air compared to the mountain of pills that most of these consumers have to take.
References:
- Mayo Clinic, “Dietary fiber: Essential for a healthy diet,” September 22, 2015. https://www.mayoclinic.org/healthy-lifestyle/nutrition-and-healthy-eating/in-depth/fiber/art-20043983
- U.S. Food and Drug Administration, “Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food,” June 14, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM610641.htm
- U.S. Food and Drug Administration, “The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels: Guidance for Industry,” June 2018. https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM610144.pdf
Sarah Beale is a content marketing specialist at MasterControl in Salt Lake City, where she writes white papers, web pages, and is a frequent contributor to the company’s blog, GxP Lifeline. Beale has been writing about the life sciences and health care for over five years. Prior to joining MasterControl she worked for a nutraceutical company in Salt Lake City and before that she worked for a third-party health care administrator in Chicago. She has a bachelor’s degree in English from Brigham Young University and a master’s degree in business administration from DeVry University.
