The story of Airborne – a popular supplement marketed as an “herbal health formula that boosts your immune system to help your body combat germs” – is representative of what is wrong with the supplement industry and how it is regulated in the US. Recently the company that sells Airborne – Airborne Health, Inc – agreed to pay $23.3 million to refund consumers who purchased the product (if they have proof of purchase). This was to settle a class-action law suit brought by the Center for Science in the Public Interest (CSPI) and others claiming false advertising. In the settlement the company did not admit any wrongdoing. While this can be viewed as a minor victory for science-based medicine, it actually highlights the many deficiencies in the system.
For background, Airborne was launched in 1999 as a supplement designed to ward off the common cold. It has been extremely successful, due largely to its slick packaging, a clever slogan that it was developed by a school teacher, and promotion by Oprah Winfrey. The Airborne brand of products has expanded, including pixie powder for children, Airborne seasonal, Airborne Jr., Airborne on-the-go, and others. Advertising urged users to take Airborne at the first sign of a cold or as a preventive treatment if about to enter a germ-filled area, like an airplane. They also cited a “scientific” study that demonstrated Airborne is effective.
What is in Airborne is nothing more than common vitamins and herbs. There is no reason to believe that this particular concoction has any health benefit (beyond the basic nutritional value of the vitamins) or specifically that it enhances immune function or helps fight off infections. David Schardt from CSPI is quoted as saying:
There’s no credible evidence that what’s in Airborne can prevent colds or protect you from a germy environment. Airborne is basically an overpriced, run-of-the-mill vitamin pill that’s been cleverly, but deceptively, marketed.
It should also be noted that Airborne is not without risk because it is a supplement. Airborne contains too much vitamin A. Two pills contains 10,000 IU, which is the maximum safe limit, but the instructions say to take three pills per day. So taken as directed Airborne contains more than the safe limit of vitamin A. This would also have to be added to vitamin A consumed in food, and of course many consumers may also be taking a multivitamin without realizing that Airborne is essentially just another vitamin pill itself.
Airborne is marketed as a supplement – in the US this means it falls under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Under DSHEA a health product can be marketed as a supplement and make “structure/function” claims for the product without any FDA oversight, as long as they place a disclaimer on their label and advertising stating that the claims have not been reviewed by the FDA and that they do not make “disease” claims for the product.
What this means is that any company can put together an essentially random combination of vitamins and herbs and make any structure/function claim they choose (boosts the immune system, gives energy, improves sleep, aids mental focus -whatever) as long as they don’t mention a specific disease by name. There is no FDA oversight to make sure their claims have been validated scientifically.
Companies are still responsible for the claims that they make, but accountability is entirely post-marketing. The Federal Trade Commission (FTC) can take action for false advertising – just as it can with toasters, vacuum cleaners, or any product. And, of course, the civil courts can always be used to seek compensation for any deception or wrong-doing by the company. But there is no pre-marketing oversight – no hurdle to get over before getting to market with specific claims.
In the case of Airborne there was no FTC action – a grass roots watchdog group, CSPI, brought a class action suit for false claims. Specifically they were able to document that there is no scientific evidence to support the claims made for Airborne. In addition, Airborne Health cited a “clinical study” to back its claim that Airborne is effective at preventing colds. But an ABC news investigation reported:
Airborne said that a double-blind, placebo-controlled study was conducted with “care and professionalism” by a company specializing in clinical trial management, GNG Pharmaceutical Services.
GNG is actually a two-man operation started up just to do the Airborne study. There was no clinic, no scientists and no doctors. The man who ran things said he had lots of clinical trial experience. He added that he had a degree from Indiana University, but the school says he never graduated.
In response to these critical news reports (and likely fear of legal ramifications) references to the clinical trial have now been removed from Airborne packaging. Elise Donahue, Airborne CEO, explained: “”We found that it confused consumers. Consumers are really not scientifically minded enough to be able to understand a clinical study.” The packaging has also been changed to remove the claim that Victoria Knight-McDowell (the school teacher) developed Airborne because she was “sick of catching colds,” and replace it with the claim that she created Airborne because she “needed help supporting her immune system.”
What we see here is the evolution of the packaging and marketing of Airborne to conform to DSHEA, which effectively shields them from legal repercussions. Scientific evidence is not needed – so why bother going through the motions of doing a “clinical study.” You are not allowed to claim that you can treat a cold, but you can “support the immune system.” Yet, the public still understands what the product is supposed to do. Airborne has created a market using deceptive claims and now they are allowed to benefit from that market.
The class action suit resulted in a settlement of $23.3 million, but the company has estimated revenue of over $150 million in 2006 alone. Such settlements are little more than the cost of doing business. The FTC is looking into also investigating the company as well, so fines may be forthcoming. While the FTC has taken up some of the slack since DSHEA, and appears sincere about wanting to crack down on fraudulent supplement claims, they are also overwhelmed and understaffed. In addition their fines are often little more than slaps on the wrist – again the cost of doing business.
This situation is not the same as otherwise legitimate companies that behave badly and need to be punished or to compensate wronged consumers. The entire existence and marketing of Airborne is based upon a deception of the consumer. Allowing such companies to continue to do business, with some tweaks to their claims and fines that are a minor inconvenience, has not been an effective protection for the consumer.
Given that Airborne is nothing more than an overpriced (and potentially unsafe) vitamin pill, and that there is no reason (either theoretically or based upon clinical evidence) to conclude that this product is of any use in fighting off germs, as is claimed, Airborne seems to be of no practical use to the consumer. It is a waste of health resources, and may serve as a source of false confidence and therefore distract consumers from effective means of avoiding infectious disease – like simple hand washing. Our current regulations have not prevented such products from getting to the marketplace, nor removed them from the market once the facts come to light.