The FDA treats Kim Kardashian's Instagram selfie as an ad campaign

Here's the text of the post, in full:

OMG. Have you heard about this? As you guys know my #morningsickness hasbeen pretty bad. I tried changing things about my lifestyle, like my diet, butnothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt alot better and most importantly, it’s been studied and there was no increased riskto the baby. I’m so excited and happy with my results that I’m partnering withDuchesnay USA to raise awareness about treating morning sickness. If you havemorning sickness, be safe and sure to ask your doctor about the pill with thepregnant woman on it and find out more www.diclegis.com;www.DiclegisImportantSafetyInfo.com. 

It's been no secret that many celebrities' social media endorsements are for sale. Five years ago, I blogged about the brazenness with which their followings are bought and sold as commercial media.

Product placements are rampant on narcissistic selfie feeds with millions of dedicated followers, but somehow the United States government decided that this selfie crossed the line into pharmaceutical advertising.

After Ms. Kardashian posted this blatant endorsement to her 42.6 million followers in July, the US Food and Drug Administration sent a letter to the manufacturer of the anti-morning-sickness medication, demanding immediate elimination of the post:

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed the Kim Kardashian Social Media Post (social media post) (2015-0069-01) 1 for DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets, for oral use (DICLEGIS) submitted by Duchesnay, Inc. (Duchesnay) under cover of Form FDA 2253. The social media post was also submitted as a complaint to the OPDP Bad Ad Program. The social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information associated with its use and it omits material facts. Thus, the social media post misbrands DICLEGIS within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and makes its distribution violative. 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1(e)(5). These violations areconcerning from a public health perspective because they suggest that DICLEGIS is safer than has been demonstrated.  

... 

OPDP requests that Duchesnay immediately cease misbranding DICLEGIS and/or cease introducing the misbranded drug into interstate commerce. Please submit a written response to this letter on or before August 21, 2015, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for DICLEGIS that contain presentations such as those described above, and explaining your plan for discontinuing use of such materials, or, in the alternative, for ceasing distribution of DICLEGIS. Because the violations described above are serious and repeated, we request, further, that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials. In order to clearly identify the violative promotional piece(s) and/or activity and focus on the corrective message(s), OPDP recommends that corrective piece(s) include a description of the violative promotional piece(s) and/or activity, include a summary of the violative message(s), provide information to correct each of the violative message(s), and be free of promotional claims and presentations. To the extent possible, corrective messaging should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated.

This is serious stuff. By treating the Instagram post as a paid ad, the FDA is bringing the full weight of its authority not on citizen Kim Kardashian, but on the company that they assume paid her to shill for them. As I'm sure you know, pharmaceutical advertising is heavily regulated. One of the most onerous parts of that regulation, for advertisers, is the endless list of risks, contraindications, and possible side effects. The FDA points out specifically that the drug has not been studied in women with hyperemesis gravidarum. Omissions like this can can prove tragic.

Since this time, the Instagram post has been removed. Furthermore, the manufacturer admitted to media that it was a paid endorsement (duh!) but that Ms. Kardashian really does take the drug and it was prescribed by her doctor. The Independent quotes Thomas Abrams, the director of the Office of Prescription Drug Promotion at the FDA, saying that the manufacturer is complying with the warning.

An FDA Q&A page states that the emergence of social media has "complicated the job" of promotional regulation, stating "we generally do not have authority over statements made by independent organizations or persons—what we call third parties—unless they are acting on behalf of a company." They also mention that this isn't the first time they have intervened.

This should be an important wake-up call for certain advertisers using celebrities as "native advertising" channels. As the line between advertising and earned media blurs, the regulators have learned to simply follow the money.

F'd Ad Fridays: Won't somebody PLEASE think about the PAs?

This crappy anti-bootlegging PSA by the US Bureau of Justice accuses people buying pirated DVDs of supporting child labour, drug trafficking, organized crime, gang violence, and worst of all...

The laying off of Hollywood Production Assistants

Please, people. Think of the PAs.

Via BoingBoing

F'd Ad Fridays: F'd Nutritional Science Edition

In my day, it was ketchup that the US government reclassified as a vegetable to meet nutritional standards for school lunches. Now, after great advanced in food science, they have decided to replace it with much-healthier pizza sauce.

In case their is any confusion, Jonathan Mann has created this helpful little PSA:



Via BoingBoing

A weirdly intense political ad from the USA

Herman Cain is a Republican running for the 2012 United States presidential nomination. A Tea Party supporter, he has been criticized for promoting tax policies that favour corporations over working people, discriminatory statements against Muslims, and absolute views against reproductive choice and equal marriage. He has also made a point of distinguishing himself as ethnically different from President Barrack Obama:

In an interview with Bloomberg view, Cain argued that he is a 'black American' rather than an 'African American' on account of being able to trace his ancestors within the US, describing Barack Obama as "more of an international...look, he was raised in Kenya, his mother was white from Kansas and her family had an influence on him, it’s true, but his dad was Kenyan". Interviewer Jeffrey Goldberg pointed out that Obama had spent 4 years of his childhood abroad, and that it was in Indonesia - not Kenya, at which point Cain revised his claim.

Cain is perhaps typical of the "businessman" style of politician, who has excelled in the private sector (as former Godfather's Pizza CEO) and believes that kind of thinking can make government more efficient. You can see this in the ads "no-nonsense" delivery. But why the conspicuous 1970s action movie style cancer stick drag by campaign manager Mark Block? Why be so weird about it?

Tom Murphy of Mother Jones gives this backstory:

"As the New York Times pointed out on Sunday, there's another side to Cain: lobbyist. And as a lobbyist for the National Restaurant Association in DC in the 1990s, Cain was one of the tobacco industry's best friends on K Street. His group received big bucks from major cigarette manufacturers, and returned the favor by opposing things like smoking bans."

So I guess that explains that. But not the slow-mo smile by Cain at the end. The Daily Beast's Michelle Goldberg Tweeted, "his smile at the end of this ad is the creepiest fucking thing I've ever seen". And it really is.

Next year's election campaigns are going to be really interesting. Especially from the sidelines.

Powerful women erased from history. What else is new?

Some of the most important women in history have been effectively removed from it. Cracked's book You Might be a Zombie and Other Bad News gives the examples of DNA pioneer Rosalind Franklin, brilliant sculptor Camille Claudel, nuclear physicist Lise Meitner and Beatrix Potter — who before she became a children's book author, basically discovered penicillin 30 years before Flemming in the playfully-titled article "Four Great Women Buried by Their Boobs".

But that's all in the past, right?

You're no doubt familiar with this picture, from the White House situation room during the deadly Bin Laden raid:

Pretty much a boy's club, isn't it?

But ultraorthodox Hasidic newspaper Der Tzitung apparently didn't think it was enough of a sausage party. So they did a little Photoshop magic:

Not only did they remove Secretary of State Hillary Rodham Clinton (who is kind of like, you know, an important player down there) but they also nuked Director for Counterterrorism Audrey Tomason from the back.

What the hell?

Update: Official response, as published in the Washington Post:

The White House released a picture showing the President following "live” the events in the apprehension of Osama Bin Laden, last week Sunday. Also present in the Situation Room were various high-ranking government and military officials. Our photo editor realized the significance of this historic moment, and published the picture, but in his haste he did not read the "fine print" that accompanied the picture, forbidding any changes. We should not have published the altered picture, and we have conveyed our regrets and apologies to the White House and to the State Department.

The allegations that religious Jews denigrate women or do not respect women in public office, is a malicious slander and libel. The current Secretary of State, the Honorable Hillary R. Clinton, was a Senator representing New York State with great distinction 8 years. She won overwhelming majorities in the Orthodox Jewish communities in her initial campaign in '00, and when she was re-elected in '06, because the religious community appreciated her unique capabilities and compassion to all communities. The Jewish religion does not allow for discrimination based on gender, race, etc.

We respect all government officials. We even have special prayers for the welfare of our Government and the government leaders, and there is no mention of gender in such prayers.

All Government employees are sworn into office, promising adherence to the Constitution, and our Constitution attests to our greatness as a nation that is a light beacon to the entire world. The First Amendment to the Constitution guarantees freedom of religion. (See below.) That has precedence even to our cherished freedom of the press! In accord with our religious beliefs, we do not publish photos of women, which in no way relegates them to a lower status. Publishing a newspaper is a big responsibility, and our policies are guided by a Rabbinical Board. Because of laws of modesty, we are not allowed to publish pictures of women, and we regret if this gives an impression of disparaging to women, which is certainly never our intention. We apologize if this was seen as offensive.

We are proud Americans of the Jewish faith, and there is no conflict in that, and we will with the help of the Almighty continue as law-abiding citizens, in this great country of our's, until the ultimate redemption.

Correction: what the holy hell?

Parents think their kids are dummies

[don't click... it's just a sceen cap. Link below.]

In January or February of 1983, my buddy Harry and I were standing in a field, up to our knees in snow. Looking around nervously, we took a stubby brown bottle out of his Adidas bag. But we'd forgotten to bring an opener.

Twenty minutes later, we were back in the field and happy to find our stash still safe under a bush. We opened the bottle, and dared each other to take the first sip. It tasted horrible, and I had to choke back the bubbles. But damn it, we drank a beer. Then we were on our way to meet the rest of our friends from Grade 7 at a chaperoned party.

Sound familiar? You may have been older or younger than 12, but if you're an adult who drinks alcohol, I'd be surprised if you waited until you were legal age to try it.

This is not to say that teen drinking is hunky-dory. Alcohol poisoning, liver damage, impaired driving, unsafe or unwanted sex, and all sorts of dangers are lurking in that bottle.

But as a parent, I haven't forgotten what teens get up to. I have a few more years before my son gets there, but I have no doubt he'll try whatever interests him — with or without my blessing.

Which is why I'm of two minds on these American ads from the Substance Abuse and Mental Health Services Administration (click this link to see them — the videos are unfortunately locked inside the otherwise social media friendly site)

The TV creative is quite good. The parents talk about their kids as if they're little angels, and the reveal shows that they're not talking about real kids at all — they're mannequins. I like what this says about parents' ability to be in denial about what their kids are exposed to.

The print also does a good job of being honest, and taking the tried-and-true approach of getting parents to at least talk to their kids about the issue:



And the web site has some decent messaging:

"If you don't talk about it, you're saying something.

What you say to your child about alcohol use is up to you. But remember, if you don't say anything to your child about drinking, you might give the impression that underage drinking is acceptable."

(Reminds me of when I tell clients that, in social media, not joining in an uncomfortable online conversation about your brand is as good as an admission of guilt.)

My problem with this campaign is strictly personal. My own opinion about teenage drinking is that it needs to be approached responsibly. Hell, I intend to be one of those parents who offers his kid a glass of wine at holiday dinners once he hits puberty.

And this is the problem. As a government initiative, the "Talk Early. Talk Often. Get others involved." campaign is still, at the end of the day, a "just say no" approach. The page with conversation tips has the following:

"Why do you drink?
Explain to your child your reasons for drinking – whether it's to enhance a meal, share good times with friends, or celebrate a special occasion. Point out that if you choose to drink, it's always in moderation. Tell your child that some people shouldn't drink at all, including children who are underage."

Would that have convinced you, as a kid whose self-image was 15-going-on-21?

This one, fortunately, is a little better:

"Did you drink when you were a child?
If you drank as a teenager, experts recommend that you give an honest answer.1 Explain why you were tempted to try alcohol and why underage drinking is dangerous. You could even give your child an example of an embarrassing or painful moment that occurred because of your drinking."

But hey... at least the American government is telling parents to be (somewhat) realistic about a social issue that affects almost everyone. However, as long as the bottom line is "it's bad for you because it's illegal" the argument has a built-in fail.

After all, this is a country that will let an adult go to jail, or go to war for up to three years before they consider them old enough to have a beer.

We've got issues

I just read a headline that made me smile: "Boom in Issues Advertising Could Net Agencies $1 Billion".

Okay, they're talking about the United States with its shiny new government, but it's still nice to have our corner of the market validated. (Coincidentally, I'm actually doing some American social issues work right now, but more about that in a later blog.)

Here in the Great White North, the recession is also driving spending in social marketing. A new Economic Action Plan needs to be explained to the public, and other government priorities like security, health and the environment continue to require outreach. The government has to advertise, no matter what the economic climate.

This is a smart time to be in Social Issues Marketing. We're busy here on a number of government, association, and corporate social responsibility campaigns that will roll out over the next few months.

But it sounds like the U.S. issues advertising boom is not quite like the Canadian one:

"With the ad business the way it is right now and a big pile of money sitting out in the world of politics, there's no doubt traditional agencies will try to jump in," said Vinny Minchillo, chief creative officer of Scott Howell & Co. ... They will fail ... It's not uncommon for political clients to have television production budgets of under $15,000 per spot and a need to be on the air in 48 hours ... The hard-core retail shops probably have the best chance of being able to adapt quickly. Also the shops with employees who don't care much about sleeping."

Yikes! And here I was thinking that work-life balance was one of the most important issues of all...

Of course, the American article is talking about the hardcore world of Washington lobbyists. I see advocacy ads in The Hill Times and on bus shelters in front of Parliament Hill every day (we've even been responsible for some of them), but for the most part our clients are asking us to execute timely campaigns based on long-term communications strategies. We've done our share of crisis communications, but nothing like the dog-eat-dog scenario painted by Mr. Minchillo.

But then again, Minchillo continues to refer to Issues Advertising as "political". Up here, "political" advertising is kind of a hot potato.

I'll stick with communicating Canada's issues with appropriate niceness.