hloe Kardashian rolls languorously in a tangle of white sheets and asks, “Do you feel sexy? Do you have the body you’ve always dreamed of?” The shot switches to her sister Kim, shimmying out of a pool and commanding viewers to “Create the body you deserve.”
Superimposed in front of the pool? A box of QuickTrim diet pills. “QuickTrim. Live the dream,” the narrator intones.
The Kardashians and QuickTrim have parted ways since that promotional video first aired in 2010. But the reality TV stars and other celebrities — including actress Nicole Kidman and former CNN host Larry King —continue to hawk nutraceuticals. It’s a fast-growing category that includes diet aids, herbal teas, and nutritional supplements that claim to promote specific health benefits, though makers don’t have to prove them with clinical trials. Just last week, Danielle Jonas — wife of Kevin, the oldest of the Jonas Brothers band — announced to her million Instagram followers that she felt “strong and fit” thanks to BooTea, which promises to deliver a shapely body with “an intense mix of natural ingredients” including dandelion and nettle greens.
article continues after advertisement
Stars aren’t the only ones drawn to the industry. Global pharmaceutical giants and scrappy startups alike are rushing into the space, putting hundreds of millions of dollars behind new nutraceutical products that can move quickly onto store shelves without much federal oversight. Nestle is even working on developing a nutraceutical meant for patients with early-stage Alzheimer’s disease.
Federal rules, enforced by the Food and Drug Administration, bar nutraceutical and dietary supplement manufacturers from claiming their products can diagnose, cure, treat, or prevent a disease. But they still have plenty of leeway. Nestle, for instance, won’t be able to say its product treats Alzheimer’s — but could claim that it boosts memory.
Such products are often labeled “all natural.” But they can have dangerous consequences.
A major study published in the New England Journal of Medicine last month traced at least 23,000 emergency room visits in the United States each year back to dietary supplements. The most common complaints: chest pain, heart palpitations, allergic reactions, and choking.
Even so, supplements and nutraceuticals don’t have to go through the same long, expensive regulatory process as pharmaceutical drugs. And the stars who endorse them don’t have to rattle off a long list of potential side effects.
They just have to smile for a selfie and post the shot on Instagram.
It all adds up to a tempting market for entrepreneurs and investors.
“It’s a little different than finding a small molecule to treat cancer, because they’ll be able to sell something before having to go through the whole FDA process,” said Bill Sahlman, an independent investor and Harvard Business School professor.
Sahlman recently invested in Flex Pharma, a new company founded by Dr. Christoph Westphal, an entrepreneur who has previously launched several biotech startups to develop traditional drugs. Some of those companies have stumbled badly trying to get their therapies through clinical trials and FDA approval.
With Flex Pharma, Westphal went an easier route: nutraceuticals. The company has developed a treatment for leg cramps made of extracts of ginger, cinnamon, and capscium, derived from a type of pepper, which it plans to sell directly to customers: No prescription — or FDA approval — needed.
The company went public in January and raised a staggering $86 million in a day. It’s already signed its first celebrity spokesperson: World-class triathlete Craig Alexander.
Other pharma giants have moved into the space too. GlaxoSmithKline recently purchased a sports nutraceutical company that sells energy drinks and snacks with names like “Maximuscle,” made from milk proteins and other ingredients. Back in 2011, Sanofi snatched up an Indian nutraceuticals company and its 40-some supplements.
And Nestle announced plans in May for a new therapeutic nutrition headquarters in Cambridge, Mass. The space will house Nestle’s booming health science branch, which launched in 2011 and has expanded in just four years to employ 3,000 people in more than 40 countries.
“We want to advance the role of nutrition in changing the face of health,” said Cathy Kerzner, an executive in Nestle’s Health Science branch.
What that means: Nestle is taking part in the development of a shake that it says will use fatty acids to supplement memory in early-stage Alzheimer’s patients.
It’s also creating other nutraceuticals with natural ingredients — which it won’t name — to target conditions like irritable bowel syndrome. As long as it’s careful with its marketing language, the company can get these products onto shelves without FDA review. A company couldn’t say, for instance, that its dietary supplement treats osteoporosis. But it could say that it promotes healthy bones.
“It gives us the advantage of accelerating products through research phase a little quicker” than the pharmaceutical route, Kerzner said.
A huge industry grows bigger
It’s difficult to pin down the size of the nutraceutical industry. Estimates vary widely — from $40 million in annual sales to an expected $424 billion by 2017 — because of the loose definition of “nutraceuticals.” Medical foods, dietary supplements, weight loss pills, herbal treatments, and more fall under the umbrella term. Some analysts even count pet food.
A recent convention in Baltimore attracted almost 1,400 exhibitors, showcasing seminars on everything from building consumer trust to identifying “the next big thing.”
The market is already huge: Studies show between half and two-thirds of Americans use dietary supplements.
“A lot of people take these products out of an abundance of caution or a healthy dose of hope,” said David Schardt, a senior nutritionist at the nonprofit consumer advocacy group Center for Science in the Public Interest.
Very few people, however, are taking them on doctor’s orders. The National Institutes of Health says more than three-quarters of dietary supplements are used without the suggestion or advice of a medical professional.
“They’ll be able to sell something before having to go through the whole FDA process.”
Harvard Business School professor
To put some more scientific eyes on the industry, the NIH announced plans in September to spend $35 million to study natural products, ranging from hops to red wine’s resveratrol to grape seed extract.
The NIH has tried in the past to verify health claims from nutraceuticals and found some promising results in small studies. But “when we did larger studies, we couldn’t replicate those findings,” said Craig Hopp, program director of the NIH’s National Center for Complementary and Integrative Health.
So the NIH is now taking a step back; the new grants will explore the basic science behind claims that nutraceuticals can improve health.
#CorrectiveAd I guess you saw the attention my last #morningsickness post received. The FDA has told Duchesnay, Inc., that my last post about Diclegis (doxylamine succinate and pyridoxine HCl) was incomplete because it did not include any risk information or important limitations of use for Diclegis. A link to this information accompanied the post, but this didn’t meet FDA requirements. So, I’m re-posting and sharing this important information about Diclegis. For US Residents Only. Diclegis is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments. Limitation of Use: Diclegis has not been studied in women with hyperemesis gravidarum. Important Safety Information Do not take Diclegis if you are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in Diclegis. You should also not take Diclegis in combination with medicines called monoamine oxidase inhibitors (MAOIs), as these medicines can intensify and prolong the adverse CNS effects of Diclegis. The most common side effect of Diclegis is drowsiness. Do not drive, operate heavy machinery, or other activities that need your full attention unless your healthcare provider says that you may do so. Do not drink alcohol, or take other central nervous system depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take Diclegis. Severe drowsiness can happen or become worse causing falls or accidents. Tell your healthcare provider about all of your medical conditions, including if you are breastfeeding or plan to breastfeed. Diclegis can pass into your breast milk and may harm your baby. You should not breastfeed while using Diclegis. Additional safety information can be found at www.DiclegisImportantSafetyinfo.com or www.Diclegis.com. Duchesnay USA encourages you to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Endorsement by Instagram
Pharmaceutical companies have to do tons of expensive testing to get drugs to market, proving them safe and effective first in animal tests and then through human trials. Then the FDA’s physicians and scientists decide if the potential usefulness of the product outweighs its risks and side effects. If a drug manufacturer can make it through all those steps, its product can get the green light.
Even then, the FDA enforces strict rules on marketing, which make quick-and-dirty endorsement selfies on Instagram almost impossible for celebrities — as a pregnant Kim Kardashian recently found out when she posted a picture of herself posing with the morning sickness drug Diclegis.
“As you guys know my #morningsickness has been pretty bad,” she wrote. “So I talked to my doctor, he prescribed me #Diclegis.”
Within days, the FDA asked Kardashian to pull down her Instagram selfie. She did — and then uploaded it again a week later with the full gamut of label warnings.
Dietary supplements don’t have anywhere near that kind of oversight.
Under the Dietary Supplement Health and Education Act of 1994, nutraceutical products don’t have to be proven safe or effective to go to market. The FDA can step in to take such products off shelves only if it hears multiple reports of illness or injury, or if a product is inaccurately labeled.
“We are faced with limited resources and a vast and very fragmented supply chain [of dietary ingredients] in the US,” said Lyndsay Meyer, the FDA’s press officer for dietary supplements. “We have to prioritize based on risk.”
The Federal Trade Commission does have some jurisdiction over false marketing claims — but its reach is limited.
The FTC has repeatedly punished Alex Guerrero, a health guru who works closely with New England Patriots quarterback Tom Brady, for making false claims that his nutritional supplements could cure diseases and for selling a powdered drink to help athletes recover from brain injury. Yet Guerrero has stayed in business; he and Brady are now business partners in a sports therapy business that sells dietary supplements.
“The bar for entering the industry is very low,” Schardt said. “You and I could set up a business and in a few days, we could be selling our own brand of supplements.”
Tackling cramps with ginger
Flex tested its muscle cramp product on a few hundred endurance athletes, asking them to count their cramps while taking the supplement.
The athletes reported fewer cramps during workouts after they’d taken the product. That small trial, plus another in which Flex induced cramps and tested subjects’ response to the supplement, gives the company bragging rights to say there’s scientific evidence the product works.
Even Flex’s investors aren’t so sure that’s entirely accurate: “It’s not what you would call definitive proof. It’s a little hard to prove anything,” said Sahlman. But he sees a big market for a leg cramp remedy — and isn’t concerned about the science holding up. “I don’t worry about what [the researchers] are doing,” he said.
Dozens of celebrities have touted herbal supplements like Lyfe Tea — made with lemon peel, ginger, and a flowering African plant known as moringa — which promises to “teatox” your body by removing toxins from the digestive tract.
There’s also the aptly named Boo Tea, whose website promises to “cut the jargon,” summing up how the tea works simply by saying it uses “the best natural ingredients for your body.” Scroll down to the actual ingredients section, and you’ll see a grocery list ranging from fennel seeds to dandelion leaves to the laxative ingredients needed to actually “teatox.”
The teas alone have drawn endorsements from dozens of stars.
Or take the nutritional supplement that reality star Snooki recently hawked on Instagram — “Squats make a booty good. @proteinworld Slender Blend makes a booty even better! Toning up with the best nutritional supplements out there :)” It’s made from whey protein, green tea extract, and extracts from the caffeinated seeds of an Amazonian shrub.
Of course, many well-known drugs have origins in natural products, like aspirin, which is derived from willow bark, and penicillin, which has roots in mold. And some of these nutraceuticals do work. Peppermint oil, for instance, has been found to relieve symptoms of irritable bowel syndrome.
But there are also risks and disappointments. One iteration of diet supplement Hydroxycut was found to be toxic to the liver. Then there was ephedra, a popular weight-loss product banned by the FDA in 2004 because it was tied to deaths. And just last month, Oregon’s attorney general sued health supplement store GNC for allegedly selling nutritional and dietary supplements containing illegal synthetic stimulants.
Then there’s the QuickTrim weight loss product the Kardashian sisters shilled.
The pills and powders promised to curb cravings and burn calories, but when the product didn’t work, both the sisters and the manufacturer, Windmill Health Products, got hit with a lawsuit. The lawsuit was settled with customers being offered up to a 50 percent refund.
Experts don’t expect celebrities to stop hawking nutraceuticals — or customers to stop buying them — anytime soon.
Celebrity endorsements of health and fitness products are “even more compelling” than their other endorsements, because so many people aspire to look like their idols — and are willing to believe a nutritional drink or pill can get them there, said Derrick Daye, a managing partner at the Blake Project, a branding strategy firm.
The perfect example? Kendall Jenner, supermodel and half-sister of the Kardashian crew. When a reporter asked her during Fashion Week how she stays so slim, she gave an endorsement that might’ve sold even skeptics on her favorite nutraceutical: She drinks 12 cups of tea to flush out her system every day.