By Melanie Zanona
This article appeared on the cover of CQ Weekly on June 1, 2015
Feb. 2 was the kind of day that every Washington lobbyist prepares for with a mix of determination and dread.
New York Attorney General Eric T. Schneiderman announced the results of a high-profile investigation his office launched that found four out of five herbal products sold at major retailers such as Walgreens and Walmart didn’t contain the ingredients listed on their labels, but were instead made of cheap fillers such as powdered radish. Schneiderman’s office slapped the chains with cease-and-desist letters demanding the products be pulled, and asked the chains for steps to verify the ingredients in supplements came as advertised.
Within hours, representatives of the $35 billion-a-year nutritional supplement industry — purveyors of such store shelf mainstays as ginkgo biloba, echinacea and St. John’s wort — mobilized. The Council for Responsible Nutrition, a leading trade group, dispatched a five-person lobbying team to member offices on Capitol Hill and commissioned a white paper that aimed to poke holes in the investigation’s testing methods. The group circulated “fact sheets” aiming to debunk the report, charging that the DNA barcode test used isn’t the proper test to determine what’s in an herbal dietary supplement. The lobbying press was augmented by the Natural Products Association, another industry group headed by a former director of the Food and Drug Administration’s division of dietary supplement programs.
“We had to immediately get up on the Hill and tell our side,” says Steve Mister, who heads up the Council for Responsible Nutrition. “When something like this occurs, you spend a lot more time playing defense.”
The findings came at a potentially sensitive time for the industry. In April, the FDA issued warnings about an amphetamine-like stimulant contained in nearly a dozen other supplements that weren’t part of the New York probe.
But the incidents turned out to be little more than a blip on the congressional radar. There were no calls for hearings, no long-shot bills calling for greater regulation or more generalized angst.
Which is just the way the supplements industry likes it. In fact, they work very hard to make sure it stays that way.
Under a 1994 law, supplement makers can tout health benefits as long as they don’t claim their products cure diseases, which would subject them to the same regulatory scrutiny as drugs. The Republican Congress has shown zero interest in changing that calculus. But the industry isn’t resting easy. Instead, it works hard to cultivate a wide range of allies on the Hill, contributing more than $1 million during the 2014 election cycle and fostering goodwill through entities such as the congressional Dietary Supplement Caucus. And industry groups react aggressively to any potential threat, no matter how remote.
“Every time I introduce a bill, no matter what it says, I guarantee you that when you walk into GNC or one of those vitamin places, there will be a sign at the cash register that says, ‘Durbin is doing it again, he’s going to require a prescription for your vitamins,’” says Senate Minority Whip Richard J. Durbin, an Illinois Democrat and leading voice for tougher oversight. “I’ve never done that and I never will.”
With over 55,000 different types of products touting everything from weight loss to sexual potency, manufacturers are accustomed to being caught between crusading officials who claim some of their goods are the modern equivalent of snake oil and consumers who swear they deliver promised benefits.
Industry officials insist that the popularity of their products makes them a target, not a generator, of spurious claims.
“Our industry is one that is always a very hot topic. It’s kind of an industry that people either love or hate, so we play on those lines,” says Dan Fabricant, the former FDA official who now runs the Natural Products Association. “We watch out for the haters and keep things in line.”
Friends in High Places
The industry has long benefited from its connections to senior senators such as Republican Orrin G. Hatch of Utah, where nutritional supplements are the state’s third largest industry and produce billions of dollars in revenue annually. Former Sen. Tom Harkin, the Iowa Democrat who headed the Health, Education, Labor and Pensions Committee and oversaw discretionary health spending as an appropriator, was another prominent backer and recipient of industry donations during his career.
“You can’t replace someone like Harkin; he has been a huge supporter,” Fabricant says. “But a big part of our activities has been to grow our bench.”
Trade organizations representing the industry collectively spent $4.1 million on lobbying in 2014, according to the nonpartisan Center for Responsive Politics — a record high for the 10 entities the center lumps in the nutritional and dietary supplements category.
The nutrition and weight-loss giant Herbalife International — which has attracted its own share of controversy (see story, p. 20) — dominates the sector’s political activity, accounting for nearly half of the industry’s total lobbying dollars last year and ranking among the top 7 percent of the 4,072 organizations that the center tracked overall.
Much of the lobbying is driven by periodic attempts to change the framework for regulating supplements. Under the 1994 law, vitamins, minerals, herbs, botanicals, amino acids and other ingredients used to supplement the diet don’t need to be evaluated by the FDA before they are sold on the market. Neither do any products that were on the market before the statute’s enactment. The FDA can intervene if a product is found to be adulterated or unsafe, or if it has a false or misleading label.
Industry representatives contend that the FDA already has sufficient power to remove unsafe products and argue that the law empowers consumers to make their own health care choices.
But opponents say the system has left the industry generally responsible for policing itself, setting up a scenario where a crisis has to happen before products are pulled from the market. Bad actors could also slip in.
“Companies that list their products as supplements when they’re not, hurt the entire industry,” says Scott Melville, president and chief executive officer of the Consumer Healthcare Products Association. “It makes our lives more difficult.”
Melville lobbies more broadly for health care products and was not included in the center’s dietary supplement lobbying totals, but his group spent just over $1 million on lobbying last year.
Industry lobbying comprises a wide swath of activities, including letter-writing and social media campaigns by member companies and grassroots efforts such as a recent Alliance for Natural Health USA campaign to provide fact-checking about herbal supplements and distance those products from more controversial weight-loss and sports training pills.
Trade groups also hold regular briefings on Capitol Hill in conjunction with the Dietary Supplement Caucus to further trumpet their message. The caucus cuts across party lines and has created some odd bedfellows in the House, with liberal firebrand Jared Polis, a Colorado Democrat, and fiscal conservative Jason Chaffetz, a Utah Republican, serving as co-chairmen.
“They’re on two completely different sides of the aisle, and yet both support our industry,” Fabricant says.
Ticking Off the Wish List
The industry has a knack for beating back undesirable bills and getting its fingerprints on ones that cross the finish line. Supplement makers had a hand in drafting certain provisions of the Food Safety Modernization Act, legislation outlining how adverse side effects are reported and a recent law targeting anabolic steroids, among others. One favored provision in the FSMA, for example, exempts dietary supplement companies from hazard analysis and control plan requirements as long as they comply with good manufacturing practices. Industry groups also pushed for language in the law prodding the FDA to issue new dietary ingredient guidance.
That’s not to say the industry hasn’t had setbacks. Advocates were unsuccessful in repeated bids between 2001 and 2009 to advance a measure allowing dietary supplements to be considered a tax deductible medical expense.
Now lobbyists are shooting for legislation that would allow pre-tax dollars in flexible spending accounts to be used on dietary supplements and are pressing authorizing and appropriations committees for more funding at the FDA.
“Ironically, we are often on the Hill lobbying for money for the industry that regulates us,” says Mister of the Council for Responsible Nutrition. “Funds keep getting diverted out of supplements. So many of the FDA’s resources go towards chasing down the crisis du jour in food.”
In the 2014 election cycle, the industry’s political action committees and executives contributed $1.1 million, with 63 percent going to Republicans and the rest to Democrats. Though the figure is a fraction of what prescription drug companies spend in a year, the industry has an enviable profile. Top recipients of industry cash include New Jersey Democrat Frank Pallone Jr., ranking member of House Energy and Commerce; Texas Republican Pete Sessions, the House Rules chairman; New York Democrat Steve Israel, a House appropriator; and Senate Majority Leader Mitch McConnell, a Kentucky Republican.
The Council for Responsible Nutrition’s PAC leans toward donating to members of the Dietary Supplement Caucus, lawmakers on committees with jurisdiction over supplements or the FDA and members from districts with an industry presence. As the organization’s priorities change, so do the recipients of those contribution dollars.
“Now we are also looking to the Appropriations Committee,” Mister says. “I expect there may be more members [on the panel] that we support.”
Trouble One Pill Away
Implicit in the efforts is that the industry is always on the edge of a crisis. Though most of the dietary supplements that are found to be illegally labeled have a relatively small threat of causing harm, there have been recent high-profile cases of supplements causing hepatitis outbreaks, strokes or even death. Enough incidents like those could convince even a regulation-averse Congress to consider imposing a more comprehensive regulatory framework.
“Supplements that are laced with steroids and amphetamines are illegal, and FDA has all the power it needs to enforce that,” says Allison Murphy, legislative director at the nonprofit Alliance for Natural Health USA. “But they are letting bad actors give the entire industry a bad name.”
Americans have increasingly turned to supplements with the aim of improving their health and wellness, a trend that is likely to continue as the nation’s health care system shifts towards a greater emphasis on preventive care. About 68 percent of U.S. adults take dietary supplements and 83 percent of Americans are confident in their safety, quality and effectiveness, according the most recent figures from the Council for Responsible Nutrition.
The dietary supplements umbrella not only includes vitamins, amino acids and herbal extracts, but also any supplements marketed to enhance weight loss, athletic ability or sexual performance. Despite the mass appeal of these products, 20 percent of respondents to a 2014 Consumer Reports survey of nearly 3,000 people were unaware that they have not been tested by the FDA for safety and effectiveness.
“The companies get carte blanche to promote their supplement without the rigors of a drug approved by the FDA,” says Pieter Cohen, assistant professor of medicine at Harvard Medical School and internist at Cambridge Health Alliance.
Health experts say lax oversight will result in products that don’t fulfill health claims or turn out to have little more than cheap fillers such as powdered garlic, rice, legumes, wheat or houseplants, as the New York attorney general’s office said it found. Such unlabeled ingredients have the potential to spawn allergic reactions.
“You could argue that they are safer if they have inactive ingredients, if you’re just taking fluff or powder,” Cohen says, while agreeing with some industry contentions that the attorney general’s investigation didn’t use the most accurate testing method. “The real risk would be if there is a sufficient amount to cause allergic reactions that wasn’t provided on the label. It’s economic adulteration. These herbs are expensive and people cut corners all the time.”
The most serious threats arise when misbranded supplements actually contain dangerous or illegal ingredients, such as anabolic steroids or synthetic stimulants. Such products will often masquerade as dietary supplements in order to skirt regulation. Cohen says current law makes it easy for companies to hide dangerous ingredients under the name of an obscure or natural-sounding plant, allowing them to slip through the cracks until adverse events are reported.
“A rogue operator might say this is a great opportunity, we’ll get something that looks like it has a natural source, and maybe because of its stimulant effects it will help people lose weight,” Cohen says. “That’s what we are seeing.”
The most recent example is a powerful, amphetamine-like stimulant known as beta-methylphenethylamine, or BMPEA, which Cohen found in a study earlier this year was contained in 11 of 21 supplements that listed “Acacia rigidula” as one of their ingredients. FDA scientists had also identified the ingredient in some products in 2013 but stopped short of recalling them or issuing a health threat. BMPEA — which has never been tested in humans — was deemed dangerous in Canada last year and supplements containing it were pulled from shelves.
At the urging of Cohen and a handful of Democratic lawmakers including Durbin, the FDA sent warning letters in April to five companies with products that listed BMPEA as an ingredient telling them to come into compliance or cease production, saying BMPEA does not meet the statutory definition of a dietary ingredient.
Durbin criticized the agency for failing to send letters to those that only list the Acacia rigidula extract and not BMPEA. Another recent study by Cohen found BMPEA in a hemorrhagic stroke patient who took a supplement that didn’t list the ingredient on its label. But aside from scattered congressional calls for action, Capitol Hill has remained relatively quiet in the wake of the report.
The most noteworthy instances of harmful ingredients include ephedra, which was banned in 2004 after being linked to serious liver damage and 150 deaths, and DMAA, which the Department of Defense banned from military bases in 2011 after it was linked to the deaths of two soldiers. The FDA subsequently issued warning letters about the substance in 2012, notifying companies to remove or reformulate those products with DMAA.
Both proponents and critics of the industry have largely agreed that FDA enforcement has lagged. Such dangerous and illegal products could have the potential to threaten the entire industry, which is why lobbyists always remain on guard and want a strong voice in the proposals that are crafted to help identify and eliminate fringe actors, while still balancing oversight of the legitimate ones.
“Unfortunately, our industry gets adversely affected by those who sell drugs as supplements,” NPA’s Fabricant says. “We would love to see FDA pursue more criminal action as a deterrent, but they haven’t.”
In Congress, the industry’s most vocal adversaries are Durbin and Democratic Sen. Richard Blumenthal of Connecticut. The pair helped ban ephedra and regularly sponsors legislation to impose stricter labeling requirements.
“The actual contents of the bottle do not always reflect the label, either in terms of quality or quantity. I think most Americans would be surprised to know that,” Durbin says. “In fact, a majority of Americans are not aware of the fact they are not tested before they are sold.”
But the measure Durbin and Blumenthal pushed in 2011 and 2013 wouldn’t have required the products to be tested like drugs. It would have ordered manufacturers to register products with the FDA and provide the agency with a list of ingredients in each supplement and evidence of any health claims. The labels also would have been required to contain more detailed warning information and the batch number.
“It’s just basic transparency so we have a record of what is being sold in America and who is selling it,” Durbin says. “I don’t think anybody ought to be able to make claims that are false.”
The bills never got a hearing or markup.
Lawmakers had a chance to go on the record in 2012 when some of the language was offered as an amendment to an FDA user fee bill. The Senate voted 77-20 to table the provision, a move likely fueled by the business-friendly and anti-regulation voices in Congress.
“It would impose another layer of regulation on an industry that already has a workable regulatory framework. It’s totally unnecessary and it’s only going to increase costs for those who use dietary supplements,” Hatch said on the Senate floor at the time. “This amendment would strap the FDA with a huge burden that it can’t afford to do now, it’s already struggling to perform its current core of responsibilities.”
The industry’s ultimate fear of lawmakers seeking to regulate supplements like drugs isn’t completely unfounded. Durbin has acknowledged he would like to see the products have stricter standards for safety and effectiveness.
“I’ve had other legislation over the years that would give FDA more authority, but I’ve learned the hard way that you have to take small steps,” he says.
There also have been targeted changes to dietary supplement oversight in the last two decades, although most of it has been supported by the industry. Hatch and Durbin teamed up in a rare collaborative effort to pass a 2006 law requiring manufacturers to report any serious adverse events associated with their products within 15 days to the FDA. The agency issued a final rule in 2007 requiring manufacturers to follow good manufacturing practices that ensure the quality of the products. And most recently, Congress cleared legislation last year to expand the Drug Enforcement Administration’s authority to go after anabolic steroids falsely marketed as dietary supplements.
Durbin says he plans to reintroduce his dietary supplements labeling measure with Blumenthal soon, although McConnell — who voted against the labeling amendment — remains highly unlikely to allow the measure to be considered on the Senate floor.
The Natural Products Association will nonetheless be waiting.
“We already teed up our grassroots on that if that bill comes out again this year,” Fabricant says.