The Food and Drug Administration’s harshly-worded letter to Duchesnay USA, the company that paid Kim Kardashian to tweet and Instagram about its morning sickness drug is a reminder that even on the wild west of the Internet, you can't just say anything. There are rules.
The agencies that oversee the promotional claims companies make about their products -- the Federal Trade Commission for products broadly and the FDA for drugs -- have begun to develop guidance on how companies can use social media channels to connect with consumers without breaking the rules.
“What’s so interesting about social media is because of the casual nature of it, the FTC has really stepped in to say: would a reasonable consumer know that a person is being paid here?” said Whitney Gibson, a partner at the law firm Vorys. Gibson said that at his firm, the business of advising companies on how people can responsibly endorse their products on social media has exploded.
“I think a lot of people are out there violating that rule, to be honest," Gibson said. "The fact is, it’s advertising.”
The first thing most people wonder when they see a weirdly promotional Facebook post or tweet is whether it's an ad.
Social media makes it more complicated to figure that out. People are generally free to say what they want about the products they use, good or bad. But the FTC requires people who are being paid by a company to disclose that when they endorse a product. The agency has published a whole guide about how to stay out of its crosshairs, but it can basically be summed up this way: if you are being paid, disclose it. It's a way to keep regulators and Internet critics at bay.
Companies may not always want that information to be disclosed. Actress Octavia Spencer won a lawsuit in which she alleged she was wrongfully terminated from an endorsement deal for a weight-loss company, in part because she insisted on hashtagging her tweets #spon to indicate they were sponsored.
That brings us to the second major question that people have about ads. Are they true? The FTC requires advertising to be "truthful, not misleading, and, when appropriate, backed by scientific evidence."
The FDA has an additional set of requirements about the completeness of advertising for prescription drugs. Saying what a drug does, for example, isn't enough. Companies also must be clear about what its risks are, and that's how Kardashian and Duchesnay got in trouble. These requirements are part of the burden that is imposed on companies, but it's important to keep in mind that these rules are less strict than almost anywhere else in the world. Direct-to-consumer advertising of prescription pharmaceuticals isn't allowed at all in most other developed countries.
The FDA's disclosure requirements can sometimes mean drug companies find themselves held to a high bar, and companies must figure out how to apply the old standards in new venues. For example, in 2009, a number of drug companies received warning letters from the FDA because they were advertising their drugs through sponsored links on Internet search engines. The brief headlines that popped up didn't explain the side effects of the drugs, and the FDA warned that wasn't sufficient.
"For promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug," the regulators wrote.
The FDA also works to make sure a celebrity's anecdotal experience doesn't overrun the evidence about what the drug actually does. In 2009, Abbott Laboratories received a warning letter for a promotional DVD in which Magic Johnson spoke about life with HIV and his experience with a particular drug, Kaletra.
"This promotional testimonial suggests that Kaletra has been shown to allow all or most antiretroviral treatment experienced individuals to successfully manage their disease and continue to do well, i.e., live a “normal life” ... for five or more years," the letter said, pointing out the absence of sufficient scientific evidence to back up that claim. "The personal experience of a Kaletra patient such as Magic Johnson does not constitute such evidence."
The drug company, Shire, was warned by the FDA in 2009 for a YouTube video that starred Ty Pennington talking about the transformative effect Adderall had on his life.
"Now once I got on medication it’s just amazing the transformation I made. It literally changed my life, and gave me the confidence to achieve my goals, like being an artist. As a kid, I never could have imagined I could do it. But with the medicines like Adderall XR, it’s truly a transformation," Pennington said.
"These claims imply an impact on aspects of a patient’s life that are much broader than those actually impacted by Adderall XR treatment," the letter stated.
The FDA last year released guidance for promoting drugs on social media with character limitations, such as Twitter. But the drug industry has challenged those requirements, attempting to use the FDA's own tweets against it. In a comment submitted to the FDA last fall, the industry trade group PhRMA questioned why the FDA will often tweet that it has approved a drug to treat a condition without mentioning the drug's limitations and side effects, while the companies can't do such a thing without falling afoul of the rules.
Even as the rules are hammered out on how regulated drugs can be promoted on new platforms, there is an even wider world of claims made about nutritional supplements, an industry that is projected to reach $38.7 billion by 2020.The FDA does not allow nutritional supplement companies to advertise their products as treatments, preventions, or cures for particular diseases.
But companies continue to make claims that sometimes trigger regulatory action. The FTC has come down aggressively against companies making false claims in this space, penalizing a supplement company that alleged its pills could treat speech disorders that are common in autism. The agency is involved in a prolonged lawsuit against Pom Wonderful over its claims on the health benefits of pomegranate juice.
Bob Ehrlich, the chief executive of DTC Perspectives, a consulting firm that focuses on direct-to-consumer advertising in the pharmaceutical industry, argues that the public is generally well protected by the disclosure requirements of the FDA. Ehrlich was vice president of consumer marketing at Parke-Davis when Lipitor was launched and saw just how much scrutiny the FDA put into the first television ad for the cholesterol-lowering drug -- down to whether a car in the background was speeding by too quickly.
"Drug companies know the penalties for not controlling who they pay," Ehrlich said. "As a consumer, to me you're much safer believing a pharmaceutical ad than a supplement ad, because [with a supplement] you’re basically taking stuff that is unproven, may not be safe, you don’t know where it’s from, and you don’t know what's in it."
Ehrlich said he considers himself a fairly savvy consumer, but personally fell prey to the dubious marketing that comes with supplements. He bought two bottles of green coffee bean extract, a weight loss supplement that was featured on the television show Dr. Oz. In January, the FTC said the company should pay $9 million for its deceptive claims that people could lose 17 pounds in 12 weeks without exercise.