Where to start? Well, as Nutrasource’s Director of Scientific Affairs Susan Hewlings suggested, start at the beginning. What is the product?
Hewlings' advice: Determine, first off, whether it will be a supplement—this can be done by investigating the product’s mechanism of action, as well as what it’s intended to do. “What is the product? What is the correct dosage? What is known about the product—is there a literature review, is there historical evidence of its usage? Who is the product intended for? Where is it made, and where do you want to sell it—this will affect regulatory pathways. How is it made? Is there established safety data?”
Hewlings focused heavily on the science—with good reason. “The literature review is your scientific backbone,” she told attendees. “It links science to marketing to regulatory, it can be used to publish in peer reviewed literature, it can be used in white papers and blogs and website material, and it provides claim substantiation.”
It's important to check out the existing science for another reason—the science that's out there may be poorly done or misleading. One example: Martie Whittekin, CCN, who presented on Aloe vera and the science behind Lily of the Desert's Aloe, noted that there are those who believe that Aloe can be dangerous. She traced this belief back to a study FDA did around seven years ago: "They performed a study on mice, using unfiltered Aloe, which contained about 13-16,000 PPM of aloin. Aloin is a yellow sap that exists in the peel, and it can cause diarrhea and more serious troubles. So these mice developed cancer and other harmful side effects, and now there's a rumor that aloe may be dangerous. However, when the study was replicated using Lily of the Desert's Aloe, with less than 1 PPM of aloin, the mice had no problems and were actually healthier than when the study began." So not only can a study be useful for proving your product's efficacy, but it can also be used to disprove misleading rumors.
When it comes time to design a study for your product, Hewlings made this suggestion: “Design a study from a question. What do you want to say about your product? What claims do you want to make? Clear research questions should be thoroughly developed to save you time, money, and FTC letters.”
A solid study can also help answer many of Hewlings' original questions. For instance, selenium may support the immune system—but how much? Vitamin C might be useful for a cold, but how often should it be taken? James DiNicolantonio, Pharm.D., Director of Scientific Affairs at AIDP, took a look at many of the nutrients used for immune system maintenance. Selenium, he noted, enhanced the adaptive immune system at 297mcg/day—that's the how and the how much. Vitamin C can be tolerated up to 2g/day before diarrhea begins, but 4g/day for adults caused a 6-9% reduction in the duration of the common cold and 6g/day caused a 17% reduction—there's the safety data. Dr. DiNicolantonio also looked at quercetin: 1,000mg daily significantly reduced URTI incidence in cyclists during a two-week period after intense exercise, which brings us to another important aspect of product development: To whom are you selling your product?
Customers Selling a product takes more than just science—it takes buyers. “Strive to become expert in both scienceandmarkets,” said Julian Mellentin, Director at New Nutrition Business. “Success results from aligning the science with consumer needs and delivering the benefit in a product. It doesn’t matter how good your science is if you can’t engage with the consumers.” And this doesn’t just mean that suppliers need to engage with manufacturers—he means the end consumer: “Give retail strategy as much thought as you give to science. Where and how is this going to be sold? How is the consumer going to find it? This is not something that you can leave to the end. This has to be part of the strategy from the beginning. Invest in consumer research, as well as science. Kerry Ingredients does a fabulous job of investing in consumer research and sharing it with their partners. Beneo does the same.”
Mellentin offered two tips. Tip #1: “Focus on ‘feeling’ the difference—products wherein customers leave reviews saying theyfeltdifferent do well. There’s nothing that promotes trust in a brand like buying a product that will make a tangible difference. And if they can’tfeelthe benefit,showthem the benefit. For instance, Anlene—the #1 high-calcium dairy brand in Asia—went around and provided consumers with free bone scans. They said it was more effective than marketing. It allowed people to understand and internalize the benefits of calcium for their bones.”
Tip #2: “Your ingredient must make sense in the product format you are selling. A few years ago, there was a push to put omega-3s in everything, like yogurt. But people aren’t expecting to find fish oil in their yogurt. They looked at the product and automatically decided it would taste like fish, so the product failed—and these products were being pushed by big companies, like Unilever.” So when it comes to digestive health, Mellentin says, make sure the product makes sense. “Probiotics in yogurt makes sense. People love a backstory about traditional usage—maybe kombucha and kefir aren’t traditional in their own cultures, but they are traditional in someone else’s. There’s no point in adding probiotics to hot teas or chocolate. That’s a very niche market—and if you want niche, well, that's one thing, but many people want to go bigger. Make your life easier. Go with what your consumer believes, or what they want to believe.”
And there’s plenty of opportunity in probiotics—Ewa Hudson, Director of Insights at Lumina Intelligence, shared some of Lumina’s data with attendees. “There is an underdeveloped area in the U.S., in probiotics for seniors, which sell better in other countries. Probiotics for children may need a re-work, too, because they don’t score as high as they probably should.” Her data showed, too, that consumers have made the link between probiotics and immune support—besides an upswing in searches on the topic, there are nearly 150,000 customer reviews for probiotics geared towards immune support in the U.S.A., as of January 2020.
Clasado Bioscience’s Business Development Director, Luis Gosalbez, Ph.D., too, had a suggestion for making products more palatable to consumers: Make the appropriate number of claims. “The average number of claims is 3.1,” he explained. “Too few and the product is unattractive; too many, and the product is regarded as snake oil, so you want to sit in that middle ground.”
Missed the event? You can access the sessions on demand here.Related: The Latest in Independent Testing FTC Mailing Refunds to Consumers who Bought Deceptively Marketed Products 10 Trends in Raw Materials
Claims Speaking of claims, we’ve all seen the news—FTC and FDAare going after unsubstantiated claims, and they’re cracking down hard. There’s plenty of confusion regarding where the line is drawn. Fortunately, the presenters at the event offered some clarity on the topic.Ivan Wasserman, Managing Partner at Amin Talati Wasserman, gave an entire presentation focused on claims, going all the way back to basics. The first thing he pointed out: There’s a difference between FTC and FDA, and there's more to worry about than those two groups. “FTC has jurisdiction over advertising—everything you say in an ad, whether express or implied, has to be substantiated. FDA says you can’t say your product treats, cures, or prevents a disease, but youcan say the ingredients in your products are great for the immune system.” And then there are the other ways advertising can be disputed: “The National Advertising Division (NAD) of the Better Business Bureau can challenge advertising, and it allows companies to challenge their competitors. So does the Lanham Act, which allows competitors to challenge each other’s advertising in court—that’s for those who don’t want to go to the BBB, for whatever reason. There’s also TINA, a consumer group that goes after what they see as false advertising—they keep a list of bad actors on their website. And then there are class action lawsuits, the bane of most marketers’ existence these days—these represent consumers who claim they were misled by something you put on your product or advertising, so they were tricked into buying the product. My law firm is typically involved with 10-20 of these a month.”
Wasserman also explained why FTC has been going afterdoctorsanda pastorin addition to product manufacturers, and why FTC typically doesn’t do that: FTC doesn’t have any jurisdiction over medical practice. If a doctor tells their patient to take vitamin C, there’s nothing there for FTC to deal with. If, on the other hand, that same doctor starts selling vitamin C, then it’s commercial, and FTC can send them a letter telling them to stop.
And while an FTC letter isn’t the end of the world—Wasserman notes that “if you stop doing what they tell you to stop doing, you should be fine—he also adds that that letter doesn’t go away. “If someone googles your company, that letter will pop up, and it may make them wonder if you’re still doing things you’re not supposed to be doing.”
In terms of direct advice: “Avoid overt disease claims,” stressed Douglas S. Kalman, Ph.D., R.D., VP of Scientific Affairs at Nutrasource. “Don’t even mention a disease or disease state. Avoid implied disease claims. Words like ‘therapeutic,’ ‘defense,’ ‘boost’—use ‘immune support’ or ‘maintains proper immune function.’” Moreover, he noted that this extends to things you link to: Not only canyounot make disease claims, but you can’t link to someone who does. “Watch in your ads and marketing to make sure you’re using the correct reference materials,” he added. “And don’t reference disease studies.”
To this Hewlings added: “FTC is paying attention to social media more than people thought they were. A lot of the flags that got their attention were things done on Twitter and Facebook.”
Missed the event? You can access the sessions on demand here.
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The next virtual event in the Naturally Informed series, powered by WholeFoods Magazine and Trust Transparency Center, is "Driving Value Through Sustainability Across the Supply Chain. It will take place August 26-27. Register here.*Note: Information in this interview is intended for educational and scientific purposes only. It is not intended as medical or nutritional advice for the treatment or prevention of disease. For medical advice, consult your personal health care practitioner.
