Lazy Larry dietary supplements look and taste like fudge brownies. They contain some of the same ingredients, including flour, trans fats, sugar and oil. And until recently they could be found among the snack foods in convenience stores.
But the brown "relaxation" treats contain melatonin, a neurohormone often used as a sleep aid. There is no safety data on its use in conventional foods, but animal studies on melatonin have raised red flags over potential adverse effects, including blood glucose problems and cardiovascular, eye and reproductive issues.
Citing health risks from products that blur the line dividing supplements from food and beverages, lawmakers are pushing for tighter regulation of vitamins, herbs, weight-loss products and other dietary supplements.
The U.S. also is overwhelmed by potentially dangerous imported ingredients from Asia, said Sen. Dick Durbin, D-Ill., whose recently introduced Dietary Supplement Labeling Act of 2011 would increase labeling requirements and require companies to register their products. "The U.S. Food and Drug Administration has neither the power nor the resources to monitor what's going on in the industry," he said in an interview.
The supplement industry, however, is up in arms over the prospect of stronger FDA oversight and additional rules governing the use of new dietary ingredients. The real problem, it contends, is that the agency is not enforcing regulations already on the books. Additional requirements would raise the cost of supplements, burden manufacturers, limit availability and infringe on a consumer's "personal freedom," representatives say.
"People want to have some modicum of autonomy when it comes to the question of what they can put into their body and what they can do for their own health," said attorney Marc Ullman, chairman of the legal advisory council for the Natural Products Foundation. "They really resent intervention by the nanny state and want to be allowed to make judgments for themselves."
But do consumers have enough reliable information to make smart decisions about the products they buy? Unlike drugs, which need pre-market approval, dietary supplements are not approved by the FDA for safety or efficacy before they hit store shelves. Labels must be truthful, but the FDA does not review them in advance.
The FDA can go after a company only if it can prove a supplement is dangerous. Even then it can be difficult to get the products out of circulation.
When Harvard Medical School researchers surveyed a group of immigrant women, for example, they found that nearly a quarter of them had used Pai You Guo, a weight-loss supplement from China that the FDA recalled in 2009 because it contained a dangerous mix of banned pharmaceutical substances. Many still were using it and had not heard of the ban.
"The FDA is hamstrung by ineffectual laws governing supplements, placing consumers in the line of fire," said study co-author Danny McCormick, an assistant professor of medicine at Harvard Medical School.
Since the Dietary Supplement Health and Education Act, or DSHEA, was passed in 1994, the number of dietary supplements has surged from 4,000 to an estimated 50,000 to 75,000. Because companies don't need to register individual products, the FDA doesn't know exactly how many supplements are being sold.
Durbin's legislation would require companies to register their products with the FDA; disclose all ingredients, including proprietary blends; and list known health hazards on the labels. Companies would need to provide a batch number so the product can be traced in case of a problem, though many companies already do that under quality control standards that went into effect last year.
The bill also targets the murky area of food, beverage and dietary ingredients by requiring the FDA to clarify the difference between a food and a health aid.
A 2009 report by the Government Accountability Office that recommended increasing the FDA's power over supplements found that foods could "be marketed as dietary supplements to circumvent the (more stringent) safety standards required for food additives."
The GAO also found that consumers are woefully uneducated about supplements. More than half of U.S. adults — or at least 114 million people — take dietary supplements, and the majority mistakenly believe that a government agency approves such products, the report said.
"It's impossible for consumers to get information about ingredients in supplements," Durbin said. "If the good players in the industry don't accept reasonable regulation to establish the integrity of their product, they open the door to cheap and dangerous products. They should see it coming."
But critics say DSHEA already spells out the definition of "dietary supplements"; the problem is that the FDA hasn't followed through on its own advice — which it issued in 2000 — to clarify the boundary between conventional foods and dietary supplements. Industry experts also say the Lazy Larry case proves the FDA can crack down on violators if it wants to do so. In July, the FDA warned the maker, HHB, that the product was a dietary supplement masquerading as a food.
The words "cake" and "brownie" have since vanished from the website and the product's original name, Lazy Cakes, was changed to Lazy Larry squares. The company also changed the packaging, said CEO Terry Harris.
"The energy being put forth in questioning a dietary supplement that is clearly labeled is wasting time and funds that should be directed at other products such as energy drinks, alcohol and tobacco, which have all consumed lives," Harris said.
Perhaps the industry's biggest fear is that additional legislation will lead to expensive, druglike FDA approval requirements for proving the safety of supplements. Durbin said rigorous pre-market testing isn't part of his bill. His gripe isn't with vitamins; he likes to point out that he takes a daily multivitamin and fish oil, though he's not entirely sure they work. Rather, his concerns are energy drinks, weight-loss products and other supplements that contain unapproved ingredients.
His legislation does ask the Institute of Medicine, which serves as an independent health adviser to the government, to review all supplement ingredients and identify those that have the potential to cause adverse events.
That review is "the most concerning" to attorney Steve Mister, president and CEO of the Council of Responsible Nutrition, an industry trade group.
"Supplements have an incredible margin of safety and very few adverse events when compared to over-the-counter drugs," Mister said.
Under the proposed paradigm, information on product labels "could warn people off a beneficial product based on just a slight risk," said Mister.
Chicago's Sara Hauber, 37, laughed at the notion that warning labels would scare consumers away from supplements. A healthy lifestyle coach — she's a certified personal trainer, yoga teacher and weight-loss counselor — she takes several supplements based on her doctor's recommendations, including vitamin D, fish oil and fiber.
"People take prescription drugs that have hundreds of potential side effects," said Hauber, who said she researches the brands she buys and would like to see strict regulation and testing of ingredients. "Nothing will stop people from taking supplements if they think there's a benefit."
In fact, supplements are under greater scrutiny than when DSHEA was passed. Manufacturers must register themselves with the FDA and must report serious adverse events. For the past year, quality control standards called Good Manufacturing Practice regulations have been in place that require companies to test ingredients to make sure the product label accurately reflects the contents.
What the industry needs is more policing by the FDA, Mister said. The agency has conducted about 200 investigations since June, but more are needed, he said. "We've lobbied to get more funding to the agency and encouraged them to fully prosecute when they find significant violations to further compliance among everyone else," Mister said.
Durbin said he believes responsible companies will profit from the additional regulations because they will have the reputation "of playing by the rules and of providing a wholesome product that is safe."
"This legislation will create additional burdens for industry who want to comply," said Ullman of the Natural Products Foundation. "Those who have ignored (regulations) will continue to ignore them."