PANEL DISCUSSION: Health Claims in Advertising

MS. FAIR: Welcome to the session on Health Claims in Advertising. My name is Lesley Fair and I am a staff attorney with the Federal Trade Commission's Division of Advertising Practices.

I'm joined today by two law enforcement colleagues, Betty Dodson of the Food and Drug Administration and Rob Reyna, an Assistant Attorney General for the State of Texas. We also have Treesa Drury who is with Modern Maturity Magazine published by the American Association of Retired Persons (AARP).

The question of the advancements in science that have happened lately and how to evaluate a health claim are, in some ways, very complicated scientific and legal issues. However, I don't think they are complicated scientific and legal issues in the fringe areas that have been the primary discussion of heath claims.

There are going to be very close calls for regulators, very close calls for advertisers, very close calls for media folks. Nonetheless, the issue and the scientific screening for health claims that we're talking about now is not nearly as complicated as the lawyers in your office tell you that it is. At the first look of an ad, obviously there are things that could be hidden in the ad that we'll never know about; that you will never find out about. But the vast majority of those kinds of questionable ads don't fall into that category.

Yes, science is changing. Yes, we are learning something new every day. No one expects members of the media to conduct well-controlled, double-blind, clinical testing on every health claim that is made. However, the same cases seem to come up time after time after time. When you look at just baldness and diet cases, you'll find in excess of 100 FTC cases in each category from 1950 to the present.

You may be able to have some weight loss, but certainly not without diet or exercise. There could be some temporary pain relief but certainly not the permanent pain relief often advertised. So very often, rather than having to feel the obligation to reinvent the wheel every time, we would suggest that there are certain issues, certain kinds of claims being made that are worthy of a red flag.

I often get calls from media clearance folks -- usually with a deadline in about 10 minutes -- saying to me, "has the FTC banned this product? Is it legal to sell?"

Under the Federal Trade Commission statute it's legal to sell virtually anything as long as it's advertised truthfully and with substantiation. Certainly, there are going to be other agencies that may have taken action. But our law applies across the board. You may advertise products truthfully and with substantiation.

Our question is, what are they selling it for? Is it legal to sell arsenic? I think it probably is under some circumstances. Is it legal to sell it for some medicinal uses? No. So we would suggest rather than focusing on the product itself, take a look at what the claims say.

Similarly, we'll get calls saying, do you have anything against Joe Smith? Well, first of all, the Joe Smith's of the world tend not to be "Joe Smith" the next time we deal with them. And second, a "stick-it-in-your-ear" weight loss device sold by Joe Smith is as deceptive as a stick-it-in-your-ear weight loss device sold by Mary Jones.

So, rather than focusing on individuals or an individual blacklist of people, companies, or products, we would suggest taking a big picture about the claim. I truly hope for the sake of your ad budget, for the sake of your circulation, that some one at some time walks into your office to buy a quarter of a million dollars worth of ad space for a pill that will lose you 30 pounds in 30 days. I hope it happens to you; I don't think it's happened to anybody yet. There are certain red flag areas that are worth further attention. For example, if there are products making these kinds of claims, you're going to want to read the ad carefully. Are they using certain kinds of techniques to sell the product? That doesn't mean that the product is unsubstantiated. It simply means take another look. Glowing testimonials. "Amazing on-air demonstrations." Or, one of my favorites -- especially in the health care area -- is the "2,000-year old ancient remedy."

And the one thing that pain, aging, weight loss, and baldness products have in common is that these are the areas where people are looking for relatively quick, easy relief. And these are some of the toughest areas for even legitimate professionals and legitimate advertisers to do much about.

Under the Federal Trade Commission Act, companies that advertise must have on hand, and at the time they advertise, objective, competent, and reliable evidence to substantiate their claims. A company that says, "oh, we don't have substantiation and haven't compiled that," may well be in violation of the FTC Act for lack of substantiation. They should have that material ready to go -- under the terms of our law -- and ready for you to see.

You will very often see copy-cat products. For example, when Retin-A was approved for certain uses by the FDA, we started seeing a lot of products advertised in magazines for Retinal-A. The "new Retinal-A". Very easy for a consumer to be possibly misled by that.

The Federal Trade Commission, as well as some of the states, have brought cases dealing with just those sorts of copy cats. Once a story hits the news about even a glimmer of hope in certain areas, you are likely to get copy cat after copy cat.

Let me finish up by mentioning advertising for professional services. The substantiation standard for advertising for health professionals and for medical and other types of health services is as if they were offering a device or a pill or something along those lines. In addition there may be rigorous state standards that apply.

The Federation of State Medical Boards has recently gone online with the public disciplinary records of all health professionals. I'm not suggesting that is an exhaustive list. Of course, it isn't. It will tell you, whether a doctor advertising in one jurisdiction has been disciplined in another. It's a resource to use, as well as your state medical licensing boards, or your state health licensing boards.

We used to see -- mainly on the Canadian border and the Mexican border -- many ads for medical treatment and services sold across the border, but not approved by the FDA for use in the United States. With the advent of broadcast stations in one part of the world that can broadcast 15,000 miles away, the borders are much closer now. And that's another area where the state and federal governments have tried to work together with our foreign counterparts.

Let me turn the platform over to Betty Dodson, my colleague at FDA.

MS. DODSON: The FDA has been fighting health fraud for over 75 years. That's a fact. And I do know that it's not going away, and it doesn't appear as though it will ever go away.

However, it changes. With the onslaught of scientific developments, health fraud changes. It becomes more sophisticated. And with those changes we have to be more proactive in the way that we educate consumers.

The FDA places health fraud in to three different categories. The first one is direct health hazards. This includes products that, when used, can directly cause injury, even death. These are extreme, direct health hazards.

The second category is indirect health hazards, where there is no direct hazard associated with the product, but it may have a significant adverse impact on the consumer, such as causing the consumer to forego legitimate medical treatment. Or the product itself may have no effect whatsoever; it just doesn't work.

The third category is economic fraud. Products of this type are promoted widely in the media. They are usually for body improvements, such as diet products.

We are beginning to see a partnering process take place around the country -- agencies and different interest groups working together to combat health fraud. It's partnering through education. It helps to spread the word. This will go much further than many things we can do as a regulatory agency. But we can educate.

Within FDA, our public affairs specialists are located strategically around the country. They are mandated to include health fraud in their public education activities. They go out to community groups and health professionals. One of the best ways we can combat health fraud is to work together, pull our resources together, cooperate.

It's partnering together to share information. It's a way we can be proactive, rather than being reactive all the time. Thank you.

MS. FAIR: Thank you, Betty. And now, Rob Reyna.

MR. REYNA: The states got involved in health fraud enforcement because we have certain tools that make it possible for us to act more quickly than federal agencies can when we spot health frauds. That's because we have a different authority under our state laws. I'll describe that to you.

We're a combination of what the Federal Trade Commission and FDA do -- but on a state basis. We have authority under our consumer protection act to stop false advertising or misleading statements that might be made about the product. Under our food and drug acts -- and in Texas our food and drug act parallels the federal act -- we have authority to stop the sale of unapproved drugs and drugs that are misbranded. Under many state laws, false advertising of drugs is specifically prohibited with very strong penalties. In Texas, we have penalties of $25,000 per day per violation, per violator. This adds up to a pretty strong enforcement tool.

The states also work together. We have a group of states that are interested in this type of case, and often we will approach a prospective defendant together because it makes for a pretty strong enforcement effort.

What we have been able to do is put together a good bank of cases as far as the types of claims that are made for scam products in the health area.

I might be able to refer you in the right direction to get information about whether or not a particular type of product is liable to cause you some sort of trouble. Let me give you my phone number in case anybody would like to give me a call about a particular product. I'm in Dallas. My number is 214-742-9698.

You may have noticed that you don't see as many ads for baldness remedies or aphrodisiacs as you used to. That's because FDA impaneled groups of experts to review the documentation as to whether or not there were any products that were safe to be sold over the counter or that were considered to be safe and effective in the treatment of either impotence or hair loss. They determined that there were none. If ads are submitted to you, you can be pretty sure that they have not gone to the FDA to try and get approval to sell those products as drugs, or to claim that they are safe for sale over the counter.

In the weight loss area it's a little more complicated. FDA has put out a monograph approving only two particular ingredients for sale over the counter as being safe and effective for weight loss. In contrast, there are 150 ingredients that they have specifically declared not to be effective.

There are several non-approved ingredients right now that we're finding in investigations of over-the-counter weight loss products. I can guarantee to you that I haven't seen any substantiation that most of these ingredients are effective in weight loss.

There are some good questions that you can ask. You can ask for substantiation. Sometimes getting substantiation is worse than not getting it. If you don't get it, at least you know you don't want to run the ad. If you get it, you may have 10,000 pages of indecipherable material that doesn't really answer questions unless you want to go out and hire an expert.

There are lawyers who can tell a company to put together a packet of substantiation or of scientific material related to a given type of product. That doesn't necessarily mean it's going to substantiate that the product works.

You may remember that there have been a number of advertisements for hearing aids in recent years. Many of them claimed that the hearing aids contained automatic noise reduction that would enable the wearer to understand speech in noisy settings. The five largest hearing aid companies were all running ads saying that they had such a product, and that theirs was the only one that worked and that they had invented this type circuit, and it was exclusive.

You don't see those ads any more. That's because it turned out not only did the circuitry not work, every company was buying the same circuitry. There was nothing fancy about it. And it didn't really do what was claimed. These are very large corporations that were advertising these circuits.

We have a good exchange of information with the federal agencies, the state food and drug officers, and other sources and groups that monitor false advertising. Call us if you have a question about a product or if you think that somebody may be trying to get you to advertise a product that's not on the level.

MS. FAIR: Thank you, Rob Reyna. Now, having heard from the government perspective, I'd like to introduce Treesa Drury, who does this for a living for Modern Maturity Magazine.

MS. DRURY: We keep in close contact with all our government sources, that's for sure. We have two publications. Modern Maturity is the flagship publication of AARP. It is bi-monthly. We also have a newspaper that goes out 11 times a year.

We put out 17 publications a year to 21,000,000 households. We also handle any complaints that our members might have against any advertiser in either of those publications. With that kind of a base, you can imagine how careful we are that advertisers can deliver what they say they are going to deliver. The people that are members of the association look at the publications as a benefit of their membership. They also trust AARP to have looked at the ads and products. There is, in fact, almost an implied endorsement. Even though we state that we do not endorse our general advertisers, nevertheless the fact that they appear in the publication means implied endorsement.

We have another problem when it comes to advertising. And that is, as those of you in the advertising business know, advertising is targeted to those in the 18 to 49 age range. That's going to change pretty soon because America's demographics are getting older and older. And pretty soon when the baby boomers -- and it begins in 1996 -- become a part of this market then everyone is going to have to start taking a serious look at people 50 and over. Because that's just where the market is going to be. It's going to be no where else.

For the time being, all the advertising agencies and the advertisers are stuck in the 18 to 49 mold. That left us with just the advertisers that wanted to talk about health, because it is generally believed that once you pass 50, you are sick. So you are either constipated, or you're about to have your second heart attack, or your bladder leaks or you're going to get osteoporosis, etc. We turn down ads for image as well as not telling the truth.

One of the best examples of an image ad was during the period when advertisers were really pushing calcium for women. Osteoporosis is very definitely a problem for women. But, the ads depicted the sweet young thing turning into the old crone. In one ad, not only did the old woman get the hunchback and some of the things that can come with osteoporosis, her dress got dirty, and her hair looked like you stuck a bowl on it and cut it off. She was very unfashionable and ugly, which shows what the media felt about aging. Let alone what the client thought about osteoporosis.

Another reason that we may turn down ads is if they imply a cure. Legally they may not come right out and say yes, we cure this. And they have all the words in the ad that the lawyers make them have so that they know they can't be sued. But, they are implying something that just isn't true, or causing the person reading the ad to assume incorrect facts. There are also certain categories that we totally exclude. We don't take prescription drug advertising. We don't take advertisements from doctors or from individual clinics. We don't take anything for baldness cures or aphrodisiacs. In addition, we don't take cigarettes, medical devices, most diet concoctions, herbal preparations, or impotence cures.

We don't take hearing aids, either. We had some wonderful fights with some of the hearing aid companies during that whole period. As a matter of fact, some of our people actually testified in the suits that were finally brought against them. The reason we didn't take them was they were promising what they could not deliver. It was really that simple. We told them if they were willing to explain that they could not restore hearing like you can restore vision to 20/20 -- with eyeglasses or contacts, in some cases -- they could advertise. We just excluded the whole category because they were all guilty of promising something that they could not deliver.

We have 31,000,000 members. We run a complaint department. We tell members they can complain to us about any problem that they have with an advertiser. When this occurs, we immediately contact the advertiser and expect that the advertiser will take care of the complaint. As a matter of fact, we also ask that the advertiser designate a staff person that we can contact directly, should a problem arise. If the complaints are not handled in a timely manner, or to our satisfaction, it is a cause to deny them further advertising.

You can imagine how careful we are about the reputation of each of our advertisers. If an advertiser cannot verify a claim, we either make them drop the claim or change it. We also look at puffery claims, like "the very best" or "the world's finest."

We state our policies in our rate cards. We have a special positive environment that we put out to let advertisers know that they are going to have to undergo this kind of scrutiny, so it doesn't come as a surprise.

How do we force change in ads? Well we say no, and we mean no. And the support is from the top, down. The board of directors as well as the executive director support our policies. If you consider that since we are the largest publication in the United States, we also have the largest page price for Modern Maturity, which is $235,000 for a one page four color ad.

So you have to really mean it when you turn down that kind of money. Do we hear from attorneys? Sure we do. Not so much now, because the word is out about our policies.

We have our own attorneys on staff as well that can assist us. And one final thing, is that sometimes the client and the agency change their ads for all of the media. And that's when we consider that we've really done our job.

MS. FAIR: Questions for our panel?

Q: How can you get management to turn away advertising dollars?

MS. DRURY: We're a little different than a for-profit magazine. We are a membership organization, and we don't have to count on the advertising money to support the publication. We have dues to support it. Which makes a big difference. At the same time, however, AARP would like to use the dues for other things than supporting the publications. So it's kind of a two way street.

Q: What do you see as the top two or three things that people should be looking for now in the health fraud area? If they were screening ads?

MR. REYNA: I think that the bill that was passed by Congress and signed by the President last fall, the Dietary Supplement Health and Education Act, is misunderstood by the dietary supplement industry. And I think we are already starting to see advertising being put forth for dietary supplement products that is not substantiated.

We're probably going to have to go through a cycle for about a year in order to sort out what types of claims can and can't be made in the vitamin and herb area. You're going to see a lot more advertising which people try to relate those products to different disease conditions. And that's not what the language of the law says. It created a misimpression that they can set up a separate sort of diagnosis industry telling you to take herbs for various diseases. And I think there is going to be probably a good bit of investigation done by the Federal Trade Commission and by the states in that area.

I think in the area of professional services there is a lot more aggressive advertising by physicians. There is also more aggressive advertising of drugs for uses that may have not been approved by the FDA. So I think those are areas in which there are more ads coming out, and we're probably going to see more activity.

MS. FAIR: Thanks to our panelists. We appreciate your work and look forward to working with you in the future.