Business is booming for nutraceuticals as consumers turn to vitamins, minerals, herbs, innovative foods and other natural products to improve their health. In 2017, the industry continued to embrace the “natural” label, extending that concept to include the idea of “clean” ingredients and packaging while focusing on sustainable manufacturing processes. Similarly, quality is more important than ever, a trend that breaks down into several categories that will gain momentum in 2018.
Trend #1: Qualifying Suppliers and Raw Ingredients
It’s happened time and time again – adverse events are reported from a supplement and further investigation reveals that the supplement’s actual ingredients don’t match what’s on the paperwork. Past examples include products being contaminated with pharmaceutical drugs, ingredients that are present at unexpected levels, or other ingredients that weren’t meant to be included. This can happen at different points in the supply chain, but one of the culprits is imported raw materials that are contaminated. Regardless of where in the supply chain this happens, the manufacturers are the ones that the FDA will hold responsible for ensuing problems.
To ensure that raw ingredients are pure, a company must hold its suppliers to the same standard that the FDA applies to manufacturers. That is, a company must perform similar checks on the quality controls, processes and corrective action plans of suppliers. Theoretically, companies should be able to rely on a certificate of analysis (CoA) from suppliers to assure them that the quality, potency and purity of the raw ingredient are sufficient. Dependence on the CoA is acceptable under CGMPs, but only after the supplier has been qualified to ensure that the CoA is reliable. However, when a company receives ingredients from suppliers all over the world, this gets complicated.
To initially qualify a supplier, a company must confirm what the CoA says. Thus, any tests that the supplier runs need to be run again by the receiving company to ensure that the results match. The company also must confirm that the CoA includes the test method, limits of that method and the actual results. Ideally, a company should perform an on-site evaluation of its suppliers through an audit which validates product GMP. However, the nutraceuticals market faces unique challenges here since so many of its raw ingredients are imported from other countries. Fortunately, the inspections by regulatory bodies of other countries can tell companies most of what they would need to know about the supplier, if such information is available2.
Qualifying Raw Ingredients
There may be times when a company uses a supplier but does not feel that the CoA is trustworthy. If this is the case and finding another supplier is unfeasible, then qualifying the ingredient itself is compliant with CGMPs under FDA’s Part 111 of Title 21. When dealing with an herbal ingredient, the plant part, genus and species must be verified through spectrophotometric methods. Additionally, and for non-herbal ingredients, companies must test for the chemical makeup, pesticides, heavy metals, solvent residue and make sure the ingredient conforms. This includeds microbiological requirements3and detection of the sterility conditions under which they may be exposed such as radiation.Document Everything
Quality is a big part of compliance, but there’s more to being compliant than producing a high-quality product. If a company carefully qualifies its suppliers or raw ingredients to ensure high quality, but can’t prove that they did, then legally it’s as though nothing was done. Word of mouth is insufficient when being investigated by the FDA. That’s why many nutraceutical companies use electronic quality management systems to document their processes. Some systems even provide specific tools for auditing suppliers and tracking quality events related to them, a useful tool when trying to qualify suppliers and/or their raw ingredients initially and ongoing in the supply chain.
Trend #2: Exploring Different Delivery Methods
The giant horse pills of the past are just that – a thing of the past. The nutraceutical markets for baby boomers and children are taking off, but these two demographics are less inclined to get their vitamins through a pill. Baby boomers are entering the time of their lives when they have to take more long-term prescription medications, so adding another pill to the list isn’t appealing. The natural way of replacing such drugs with claims from dietary supplements has always been an industry challenge as well. It’s never been easy to get children to take pills, so companies have traditionally turned to chewable tablets or gummy vitamins. However, parents worried about added sugars are now avoiding these options. This creates an environment where creativity and innovation produce new delivery methods.
Lozenges, drops, gums, lotions, liquids, powders and sprays are all joining traditional pills on store shelves as viable “natural” alternatives for anyone who doesn’t want a pill. Companies making children’s products are swapping out the added sugars for stevia extract or other natural sweeteners and taking strides in providing gluten-free, dairy-free, soy-free products with short ingredient lists. Since these delivery methods are different, the way the ingredients are absorbed varies as well. For example, one company manufacturing a vitamin D spray found that a transdermal delivery is more absorbable than oral delivery4.
Challenges with New Delivery Methods
Most new delivery methods are still oral, even if the goal is to present the supplement in an easier-to-swallow form while ensuring effective digestion. However, some companies have developed lotions and sprays to introduce the supplement through the skin. The transdermal delivery method might be more effective when it comes to absorbing certain vitamins and minerals, but it also comes with its own set of challenges. First, a company must determine if there are any risks with absorbing the supplement in a novel way. Will the delivery method bypass any of the body’s defenses in such a way that there’s a higher risk? Does the delivery method cause different or worse side effects? Since these are new approaches, does research indicate that the supplement can even be absorbed via the new delivery method? These problems are best addressed by looking at the product’s actual formulation and the effective performance of clinical trials.
These questions must be considered for new oral delivery methods as well. In the case of certain powders, drops, gums or lozenges, absorption is sublingual or buccal, which surpasses the digestive system and allows the supplement to enter the bloodstream at a much faster rate. Another problem is simply making the product taste good. Since the market for dietary supplements typically includes those who are health-conscious and staying away from sugar and artificial sweeteners, making a great-tasting product becomes a real challenge. Stevia is the go-to sweetener for this industry, due to its image as “natural” and the familiarity that many consumers have with it. In the coming year, companies will continue to experiment with ways to make their supplements taste good at a zero-calorie count.
Opportunities with New Delivery Methods
Some of the new delivery methods aren’t designed to circumvent the digestive tract – they’re designed to survive it. New technology presents nutraceutical companies with opportunities that didn’t previously exist. A prime example of this is probiotics, certain strains of which can’t survive prolonged contact with stomach acid. For probiotics to do their jobs in the small intestine, they have to make it through the stomach. Some companies are now designing capsules specifically designed to remain intact through the stomach and dissolve in the small intestine. Other companies are focusing on providing a probiotic that doesn’t need to be refrigerated and has a longer shelf life. Companies addressing problems in the production of other nutraceuticals will carve themselves a place in the market by innovation. Another good example of this is the absorptive science of Co-Q10 for substantive cardiac performance.
Trend #3: Blurring the Line Between Foods and Supplements
Going along with the idea of mixing up delivery forms is the idea of getting consumers to use foods and drinks as their primary sources of vitamins, minerals and herbs. The idea that food is medicine is one of the central tenets of the alternative medicine industry. A supplementby definition is an additive that provides a specific enhancement of body function whether is be in food, beverage or dose form while certain foods provide a nutritional improvement. Studies involving foods are becoming more common and certain health claims can legally be used (i.e., oatmeal promotes cardiovascular health). Other foods lack sufficient evidence to make a claim, but can still capitalize on the public’s perception of those foods. These functional foods which claim big health benefits are to a certain degree stepping on the toes of the nutraceutical industry, but the trend is to embrace foods and drinks, not compete against them.
Functional Foods are Taking Off
A prime example of this that has been popular for some time is yogurt as a source of probiotics. The marketing strategy of some yogurt companies has essentially been, why take a pill for gut health when you can enjoy a delicious, creamy yogurt and get the same results? The problem with this approach is that the FDA and FTC aren’t any more lenient when foods make health claims than when supplements do. Saying that yogurt contains probiotics is one thing, claiming that yogurt will regulate a consumer’s digestive system is something else. Caution is still needed when it comes to marketing.
Companies entering this space should start small – in more ways than one. People love to snack, but many traditional, convenient snack foods are considered unhealthy. Combine that with consumers looking for food with additional health benefits and you produce a market that’s eager for functional snacks5. Turmeric, collagen, probiotics/prebiotics, hemp and chia are just the tip of the iceberg when it comes to nutraceutical ingredients that are perfect additions to transform a snack into a functional snack.
Functional Beverages – Where Things Get Tricky
If the line between food and supplements is sometimes blurry, it’s even worse between beverages and supplements. While certain supplements are liquids, it’s obvious they’re not beverages. Examples of this include liquid dietary supplements that are only meant to be consumed in small doses and have that dose listed. When the dose is large enough to resemble the serving size of a conventional beverage, the term “dietary supplement” may not apply. According to the FDA’s guidance on the subject, a liquid’s classification as a conventional food versus a dietary supplement is largely determined by packaging, how much of the liquid is meant to be consumed, the product or brand name, and marketing statements6.
An example of a dietary supplement that might actually be a conventional food is tea. Green tea extract taken in a capsule form is clearly a dietary supplement. However, green tea sold in a can similar to a soda can with an 8-ounce serving size would probably be considered a conventional food under the FDA’s guidance (just read the label on an energy drink). This uncertainty can present problems due to the different requirements for conventional foods and dietary supplements. The number of products in this category will grow in the coming year, but nutraceutical companies need to be aware of which category their products fit into to ensure compliance.
Trend #4: Conducting Clinical Trials on Nutraceuticals
There are several ways in which the nutraceutical industry has mimicked the pharmaceutical industry. The latest of these involves conducting clinical trials on new products. Being able to say that the product performed as advertised in a clinical trial is a competitive advantage over other products that simply state a traditional use. While clinical trials are not required for compliance, using clinical trials to produce a better product does result in higher quality. This is a positive trend, both because it ads legitimacy to nutraceuticals and because it provides a better product for consumers, but there are several points to consider.
Why Existing Studies Won’t Cut It
Existing research can be useful to a nutraceutical company—but only as an indication of what a certain ingredient might do if included in its products. Using existing studies to substantiate claims is risky and companies need to consider 1) the type of study and 2) the ingredient(s).
Take, for example, a nutraceutical company that wants to market its berberine extract as an effective way to regulate blood sugar. The company looks at existing studies and finds one showing that berberine does, in fact, control blood sugar. However, the study was conducted on animals. This may not be adequate support for a claim if a company is investigated by the FTC. The type of animal, route of administration, dosage, extraction process and concentration of the extract are all factors that may make this study inadequate. As far as regulatory bodies are concerned, the best evidence comes from well-controlled human clinical studies1, although this is not the only kind of acceptable evidence.
The other factor is making sure that the ingredient from the study matches what the company plans to use in the product. Going back to the berberine example, a study using goldenseal cannot be used to substantiate claims about a berberine extract. While goldenseal does contain berberine, the intervention must be specific to the product that the company is trying to market. Similarly, a combination product that contains berberine and other ingredients is not validated by a positive study that solely examines the effects of berberine. If a combination is being sold, the study must substantiate that combination, not its components.
Use Extreme Caution When Marketing
The FDA might have jurisdiction when it comes to nutraceutical products, but the FTC has jurisdiction when it comes to advertising. Even with a successful clinical trial, there are still limitations on what advertising can say or imply. When it comes to messaging, the FTC is concerned with the overall impression. If you don’t say that your glucosamine product treats arthritis, but you say that a clinical trial showed it supports healthy joint health, this is still considered a health claim and requires substantiation. Several other points worth considering include:
- The entire body of evidence: The company may have a legitimate, well-designed study showing that the product performs as advertised. However, if one positive study is outnumbered by many more negative ones, this is considered misleading, and the FTC can take action.
- Disclose qualifying information: If a company has positive studies supporting its product, but doesn’t include all relevant information, the advertising is misleading. A good example of this is a weight-loss supplement. If there are multiple studies fitting the above-mentioned criteria that show this supplement helps participants lose weight, the company can say this in its advertising. However, if the participants of these studies also went on a diet plan and underwent an exercise program for the duration of the study, this must be disclosed.
Finishing What You Start
Conducting a clinical trial is a new concept to many nutraceutical companies, and the process is complex and difficult to manage. This at least partially explains why so many clinical trials involving dietary supplements go unfinished. Over the past 10 years, the number of registered clinical trials has steadily increased, as has the amount of clinical trials that make it to completion. However, over the same time period the amount of published results from year to year has virtually remained the same. At the time of this writing, of the 5,622 completed dietary supplement clinical trials on ClinicalTrials.gov, only 516 have published results – a mere 9%!
Not finishing and publishing the results of a clinical trial defeats the purpose of conducting one in the first place. The air of legitimacy from clinical trials only comes with published results, and the clinical trial isn’t really complete until this happens. Some companies may hesitate to publish negative results, but this also adds credibility to the company and should serve to point its product development process in the right direction.
Trend #5: Getting Creative with Protein
Protein is easily the most popular macronutrient, no longer the obsession of only athletes and bodybuilders. Most consumers are now worried about protein consumption and looking for ways to get their protein besides the traditional meat and dairy products. For vegetarians and vegans, these sources aren’t options and plant sources are becoming more and more popular. The coming year will see companies not only diversifying the sources of protein that they use in their products, but also the kinds of high-protein foods that they offer their consumers.
Perhaps the most unique form of protein being used by nutraceutical companies is insect protein. While not vegetarian- or vegan-friendly, this option is considered a more sustainable option compared to meat. Beetles, crickets and mealworms are forming the base of a trendy protein source that the Western world is only beginning to tap into. This might be a new market, but its project growth rate is huge – expected to reach $520 million by 20237. The biggest obstacle to this market is the stigma associated with eating bugs. It certainly helps that the bugs are usually in a powder form, but it will still take time for consumers in general to become comfortable with eating bugs.
New Trends in High-Protein Foods
Protein bars and shakes are nothing new, but protein pancakes, cookies, chips and breads are more recent developments in the market. The current trend shows that consumers want snacks and baked goods that are high in protein (containing at least 10 grams per serving)8, indicating that consumers are anxious to find and enjoy guilt-free versions of their favorite snack foods. Most of these products use plant-based protein in the form of grains, pulses, nuts and legumes. One of the challenges facing this market is to formulate a recipe that tastes good and delivers the maximum amount of protein. For example, using bean flour lends a flavor to the product that may be undesirable, especially in baked goods that are meant to be sweet.
Where Nutraceutical Companies Fit In
Larger nutraceutical companies are likely dabbling in at least the protein powder market already. Meal-replacement powders have been a hot category for years, but expanding into prepared beverages and foods presents new opportunities. An additional benefit is that all of these products fall under the “natural” umbrella, which means the same group of consumers who are shopping for dietary supplements are also looking for protein-fortified food, beverages and powders. When competing against food manufacturers, nutraceutical companies’ biggest advantage is their familiarity with “clean” ingredients and formulas. This is most advantageous when dealing with powders, since these consumers are most concerned with what goes into the product. In the coming year, more nutraceutical companies will move into food, beverage and/or powder product, if they’re not already there. Successful companies will be the ones that can produce the best-tasting, cleanest product with the highest amount of protein.
How MasterControl Can Help the Nutraceutical Industry
More than 1,000 regulated companies throughout the world use MasterControl’s quality management solution to comply with global regulatory standards and get their products to market sooner.
MasterControl provides an effective framework for automating and connecting all quality system processes throughout the product lifecycle.
MasterControl’s QMS suite core offerings include:
- MasterControl Documents™: For many manufacturers of nutraceuticals, MasterControl Documents serves as the foundation for building a robust quality management suite. It allows users to track, search, retrieve, route, review, and approve documents electronically, increasing efficiency while simultaneously reducing the possibility of human error and lost documentation. Because the module has been designed to consolidate document control with other quality system management processes, such as design control, audit management, CAPA, risk management, supplier management, and bill of materials (BOM) management, it provides the enhanced visibility management needs to react and adapt to the latest business and industry trends.
- MasterControl Training™: Nutraceutical companies use MasterControl Training to automate the distribution and monitoring of training tasks. Due to increasing oversight from the FDA and FTC, implementing a robust training module is critical to ensuring that all employees are properly trained to the latest standards and regulations and internal company procedures.
- MasterControl CAPA™: Nutraceutical companies need to maintain control of their CAPA processes to avoid regulatory penalties. MasterControl CAPA is a closed-loop, easy-to-use solution that streamlines the management of quality events from root cause investigation through the implementation of the preventive action.
- MasterControl Audit™: Nutraceutical companies use audits to prove their processes and procedures are compliant with SOPs and regulatory standards, mitigate risks, manage supplier quality, and increase organizational transparency. MasterControl Audit is robust enough to handle all of these tasks. It offers powerful reporting tools and the capability to connect the audit management process with other critical quality processes.
- MasterControl Risk™: Risk management has become an integral part of the design, development and production of nutraceuticals. MasterControl Risk provides a single platform for all risk-centric activities and documentation to help drive an organization’s compliance goals.
- MasterControl Supplier™: This “one-stop shopping” solution integrates supplier management with the quality management system and provides a single repository for all supplier quality data and documentation. It allows users to create scorecards for the evaluation of suppliers. It also provides robust tools for tracking and trending supplier quality events such as deviations and supplier quality action reports (SCARs).
- MasterControl Customer Complaints™: In any business, complaints are inevitable. In a regulated environment, listening to and acting on those complaints is essential. MasterControl Customer Complaints centralizes complaints so that monitoring and following up on them is simpler. Managers can monitor complaints from initiation to resolution and make sure complaints are taken care of in a timely manner.
- MasterControl Nonconformance™: This tool helps nutraceutical companies deal with products that don’t conform to CGMPs. Unlike paper-based systems, MasterControl Nonconformance streamlines your process to connect all responsible personnel, reduce turnaround time and automate tracking data.
- The nutraceutical industry is booming and this is the best time to expand into new markets, new products, and new processes to increase the quality of what’s produced and to keep consumers satisfied. These trends come with their own set of challenges, but there are also opportunities for companies willing to adapt and embrace the future of the industry.
1U.S. Federal Trade Commission. “Dietary Supplements: An Advertising Guide for Industry.” https://www.ftc.gov/tips-advice/business-center/guidance/dietary-supplements-advertising-guide-industry Accessed March 9, 2018
2 Price, Edward S., “Sourcing Raw Materials for Chemical Manufacturing: Key Tips for Qualifying Suppliers,” June 30, 2017. http://www.pharmoutsourcing.com/Featured-Articles/339542-Sourcing-Raw-Materials-for-Chemical-Manufacturing-Key-Tips-for-Qualifying-Suppliers/
3 Das, Rupa, “Botanical Raw Material Qualification,” May 3, 2016. https://www.naturalproductsinsider.com/manufacturing/botanical-raw-material-qualification
4 “New vitamin spray bottles to help beat deficiencies,” March 1, 2018. https://www.nutraceuticalbusinessreview.com/news/article_page/New_vitamin_spray_bottles_to_help_beat_deficiencies/140154
5 Morton, Claire, “The Analyst’s Take: Snacks are the hottest category in functional foods,” January 18, 2018. http://www.newhope.com/market-data-and-analysis/analyst-s-take-snacks-are-hottest-category-functional-foods
6 U.S. Food and Drug Administration, “Draft Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods,” December 2009. https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm196903.htm
7 Rutberg, Shara, “Beetlemania: Edible bugs heading to $520M,” January 3, 2017. http://www.newhope.com/breaking-news/beetlemania-edible-bugs-heading-520m
8 Berry, Donna, “Snacks powered by protein,” July 11, 2017. https://www.foodbusinessnews.net/articles/9656-snacks-powered-by-protein
MasterControl Inc. creates software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner. MasterControl’s integrated solutions accelerate ROI and increase efficiencies by automating and securely managing critical business processes throughout the entire product lifecycle. More than 1,000 companies worldwide, ranging in size from five employees to tens of thousands, rely on MasterControl cloud solutions to automate processes for new product development, clinical, regulatory, quality management, supplier management, manufacturing and post-market surveillance. MasterControl solutions are well-known for being scalable, easy to implement, easy to validate and easy to use. For more information, visit www.mastercontrol.com.