En español | Retired attorney Robert Burns, 79, of Crystal River, Fla., was concerned that he was losing short-term memory, and consulted a pharmacist at his local CVS. "You might try this," he recalls the pharmacist saying, pointing to a dietary supplement rich in omega-3 fatty acids. "This is something we produce. It has been clinically tested and should work."
It didn't. "I started getting stomach cramps and headaches," Burns says. After three weeks of unpleasant side effects and no discernible results, Burns thought, Enough is enough. He is now a plaintiff in a federal lawsuit accusing CVS of misleading advertising.
Americans buy $37 billion worth of nutritional supplements a year, ranging from simple vitamin and mineral pills to sleep aids, muscle powders, memory enhancers and self-proclaimed disease cures. Sales are rising, thanks to the millions of boomers now facing age-related health conditions, including memory loss. A study published in March by researchers at the University of Illinois at Chicago found the proportion of adults between ages 62 and 85 using supplements rose from 51.8 percent in 2005 to 63.7 percent in 2011. Those using multiple supplements jumped nearly 50 percent.
Unlike prescription or over-the-counter medicines, supplements are regulated by the U.S. government as food, not medicine, so manufacturers don't need to prove to regulators that their products are effective or safe before coming to market. Some supplements safely help prevent or ease various health issues. But some supplement makers put claims on their labels that are false — and sometimes even dangerous.
The problem often lies with the product's marketing. Regulators prohibit supplement manufacturers from making false or misleading claims. But they don't actively police the industry, and usually take action only after getting consumer complaints. Consequently, tens of millions of dollars are being spent on ineffective or even dangerous supplements, which older adults can ill afford, advocates say. In some cases, users of these products are missing out on approved treatments or remedies, taking supplements with life-threatening ingredients or using them in high-risk combinations with prescription drugs.
Targeting older consumers, a host of new products now claim to boost memory, with some even suggesting they can head off or reverse dementia and Alzheimer's disease — even as mainstream science has yet to find a cure. These claims are starting to get attention from regulators and lawmakers.
"There's a special place in hell for anyone marketing dietary supplements that falsely claim to cure Alzheimer's or dementia — but that's exactly what we have seen manufacturers doing," Sen. Claire McCaskill (D-Mo.), the ranking member on the U.S. Senate Special Committee on Aging, said in a statement. Last year, McCaskill sent letters to 15 retailers seeking information on their policies and procedures for marketing supplements, after she learned about a supplement called Brain Armor that was being advertised as "protection" against Alzheimer's, dementia and stroke.
Last November, the Justice Department announced a nationwide sweep of more than 100 makers and marketers of supplements. The companies were accused of making unsubstantiated claims about everything from treatments for Alzheimer's disease to cures for people addicted to pain medications.
The Federal Trade Commission (FTC) recently settled charges against a California firm that claimed one of its supplements relieves symptoms associated with menopause, including hot flashes and weight gain. The agency also settled charges against two supplement marketers who claimed their products could prevent gray hair or restore its natural color.
Even criminal activity is charged in some cases.
Federal prosecutors are pursuing a case against the owners of a Dallas-based supplement company that marketed a weight loss product called OxyElite Pro, which was linked to an outbreak of hepatitis and liver disease. Among the victims: Sonnette Marras, 48, of Hawaii, a mother of seven, who died after taking the supplement in 2013.
Too little, too late
Consumer advocates say regulatory and legal action, while justified, often comes only after large numbers of people have been ripped off or injured. Even after settling charges related to a product, supplement makers are often able to continue selling it.
"Companies get away with selling billions of dollars' worth of supplements that don't live up to their advertising claims, and may be dangerous," says Julie Nepveu, a senior attorney with AARP Foundation Litigation. "Paying a million-dollar fine imposed by regulators doesn't stop them from making claims that are not true. It's just part of the cost of doing business."
A 1994 law, the Dietary Supplement Health and Education Act, opened the floodgates. Under that law, anything labeled as a dietary supplement is assumed to be safe until proven otherwise. The Food and Drug Administration (FDA) is supposed to police supplements that contain ingredients that harm the public, and the FTC monitors the industry for false and misleading advertising. But with between 50,000 and 100,000 dietary supplements now sold in retail stores and on internet sites, these agencies are outmanned and outgunned.
"It presents a huge law enforcement challenge," says Richard Cleland, assistant director of advertising practices at the FTC Bureau of Consumer Protection. "The resources have not grown commensurate with the size of the dietary supplement market. It is a little bit like chasing a Ferrari in a Model T."
Consumers should not assume that a widely sold supplement is safe. "Approval is not required, and we only have resources to look at a very small minority of products," Cleland says.
In the case of the supplement that Robert Burns bought from CVS, the main active ingredient was supplied by a unit of Royal DSM, a nutrition firm based in the Netherlands. In 2014, as part of a settlement with the FTC, DSM agreed not to claim that the ingredient — an omega-3 fatty acid called DHA that was extracted from algae — improved memory.
A DSM official said the company stopped marketing its own DHA-based product, which was known as BrainStrong, and sent notification of the FTC settlement to customers who were using the ingredient in private-label products. According to CVS, the product label was updated at the end of 2015, after Burns purchased his bottle with a label promising "clinically shown memory improvement." The revised label now reads, "pure DHA memory support." The class-action suit against CVS — which says the supplement is still being marketed in a misleading way — is ongoing.
Hugh Welsh, president of DSM's North American operations, says that DSM stands by a study it conducted showing that the supplement improves memory, but agreed to settle with the FTC because of the costs of litigation. "We paid no penalties … and the consent decree set a substantiation threshold with which we were comfortable," he says.
The makers of another brain-related supplement, Procera AVH, made the bold claim that it was proven to restore up to 15 years of lost memory in as little as 30 days. Federal regulators caught up with the firm — but not before it had rolled up nearly $100 million in sales between 2006 and 2013.
As part of a settlement of FTC charges last year in the U.S. District Court for the Central District of California, five companies and two individuals agreed to stop claiming Procera AVH improved memory, and to pay a $1.4 million penalty.
One of the defendants, KeyView Labs of Tampa, Fla., said it has "completely restructured its business" since the FTC settlement and now markets Procera as a way for boomers to improve "brain health" rather than memory. But the company continues to include on its website a study that claims Procera AVH improved memory in users.
"People can read into it what they want, and the company hopes they will read it has some restorative, curative or magical powers," says David Schardt, senior scientist for the Center for Science in the Public Interest, a Washington nonprofit research group that examined KeyView's claims and found no evidence Procera delivered more benefit than a placebo. The FTC said KeyView and the other defendants falsely claimed that the study proved Procera was effective.
Josh Reynolds, who codeveloped Procera AVH, is a "direct response marketing consultant," according to his LinkedIn profile. Reynolds, of Laguna Beach, Calif., admitted in an interview that he has no advanced training such as a Ph.D. or M.D., although he has self-published a book on brain health. He defends the way Procera AVH was advertised, saying ads were modified with feedback from users and watchdog groups. "It was a big shock when we heard from the FTC," he says. "We had no intent of deceiving the public."
Sen. Claire McCaskill isn't buying it. "The worst actors in this industry are targeting seniors and caregivers," she says. "The current environment for these companies is such that the scientific and safety hurdles ... are almost nonexistent, and that has to change."