Cheerios Combatting Cholesterol

FDA: Cheerios Claims Could Make It A Drug

Must stop promoting as reducing cholesterol by certain percentage or face seizure and injunction

See article at: Broadcasting & Cable

By John Eggerton -- Broadcasting & Cable, 5/12/2009 2:46:03 PM MT

The Food and Drug Administration has warned Cheerios that it will either have to stop promoting the cereal as reducing cholesterol by a certain percentage or face seizure and injunction against manufacture.

That is because if it continues to maintain that the cereal can lower cholesterol by 4% in six weeks, the FDA says, the government will consider the cereal a drug, and a new drug at that, which cannot be marketed at all without being submitted first for approval to the FDA.

That is according to a letter to the company on the FDA web site.

Cheerios maker General Mills stood by the claim, but said it would work with the FDA to address its concerns.

The FDA letter, dated May 5, gives General Mills 15 days from receipt of the letter to correct the violations or face "enforcement action without further notice," adding that "[e]nforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products."

The FDA points out in the letter that it has approved the claim that soluble fiber from whole grain oats, which Cheerios is made from, is associated with a reduced risk of coronary heart disease. The claim can also include that Cheerios, for example, reduces that risk via lowering LDL cholesterol. Where the claim by Cheerios manufacturer General Mills runs afoul of the rules is by including a percentage of reduction. The rules state that the claim cannot attribute any degree of risk reduction for heart disease, and the FDA considers LDL cholesterol (so called "bad"
cholesterol) levels to be a "surrogate endpoint" for coronary heart disease.

In a statement, General Mills spokesman Tom Forsythe defended the cereal's claims. "Cheerios' soluble fiber heart health claim has been FDA-approved for 12 years, and Cheerios' "lower your cholesterol 4% in 6 weeks" message has been featured on the box for more than 2 years," he said. "The science is not in question. The scientific body of evidence supporting the heart health claim was the basis for FDA's approval of the heart health claim, and the clinical study supporting Cheerios' cholesterol-lowering benefit is very strong. The FDA is interested in how the Cheerios cholesterol-lowering information is presented on the Cheerios package and website. We look forward to discussing this with FDA and to reaching a resolution."

At press time, the company was still promoting the cereal on its Web site as helping reduce cholesterol by 10% in one month.

“I don’t understand the FDA’s logic in issuing a warning letter to General Mills for their claims that Cheerios can lower your cholesterol,” said Adonis Hoffman, senior VP and counsel for the American Association of Advertising Agencies. “If the claim is truthful, not misleading and can be substantiated, what sense does it make to require a food product to be treated like a drug? Where does such a policy lead us when it comes to claims for healthful foods such as broccoli, milk, eggs, beef, oatmeal and many, many more?”

Erectile Dysfunction Commercials are Not Indecent

by Adonis Hoffman

On April 29, Congressman Jim Moran (D-VA)introduced HR 2175, the "Families for ED Advertising Decency Act".

The legislation would change the law to require the FCC to interpret and enforce its regulations to treat any ad for "a medication for the treatment of erectile dysfunction or for male enhancement" as "indecent material" and prohibit such ads on radio or television from 6 a.m. to 10 p.m.

Recognizing that many things often get turned around in the heat of the debate, I felt compelled to point out a few important facts. Let's call them the 10 C's of ED advertising.

1. Concern for Children--Underlying the legislation is a legitimate concern for protecting children from inappropriate commercial messages. This is a lofty and laudable objective for any public policy, and as a parent I agree totally with the goal. Although the bill has this aim, the proscribed enforcement will not accomplish the objective.

2. Conditions--We often lose sight of the fact that ED commercials promote medicines for a legitimate medical condition, which while ridiculed, is no laughing matter to the thousands of men and couples who suffer from it.

3. Comfort--One of the many side effects of ED medications beyond headache, loss of vision, and nausea, is the ominous "four hour erection" . Because FDA regulations require these ads to cite all known benefits and risks, this side effect has to be plainly stated or articulated. That alone, makes many people uncomfortable.

4. Censorship--The new law would require the FCC to treat ED advertising the same way it treats highly salacious visuals, pornography and other "indecent"material. This would amount to an unacceptable level of government censorship, which if polled, probably would be rejected soundly by the average man or woman on the street.

5. Constitution--There are serious questions as to whether such a ban on advertising would pass the Court's long-developing test for the protection of "commercial speech". After all, as long as the ads truthfully promote a legal product, the government has to show a compelling interest in limiting their publication and get around a presumption that there may be less restrictive alternatives to such a limitation. It is doubtful the Moran bill could pass these well-established constitutional tests.

6. Conversation--Often overlooked in the debate on DTC advertising in general, is the fact that these commercials have proven to drive patients to doctor's offices and as a result, engage in a conversation about their health. In the case of ED, thousands of men not only have begun the conversation, but in the course of treatment have discovered they suffered from previously undiagnosed conditions, including high cholesterol, diabetes, and hypertension. For men of color, these conditions are even more prevalent.

7. Clearance--Any commercial that appears on broadcast television has gone through a series of clearances to make sure they meet a laundry list of criteria. In the case of ED commercials, the clearances have been even more strict, as pharmaceutical companies and their advertising agencies now voluntarily submit the ads in advance to the FDA for its opinion as to their propriety. Of course every network has its own in-house standards and clearance advisor (often called censors) to make sure that commercials and program content meet their standards.

8. Code--The Pharmaceutical Manufacturers of America (PhRMA), the trade association for drug companies, instituted an industry-wide set of Guiding Principles on DTC advertising which establish a notable self-regulatory regime. Sweeping in their application, the PhRMA Guidelines set up very reasonable rules of the road for drug advertising. Principle 16 speaks to this problem directly: "In terms of content and placement, DTC television and print advertisements should be targeted to avoid audiences that are not age appropriate for the messages involved. In particular, DTC television and print advertisements containing content that my be inappropriate for children should be placed in programs or publications that are reasonably expected to draw an audience of approximately 90 percent adults (18 years or older)."

9. Corporate Responsibility--The behavior of the drug companies in upholding this principle can be viewed as a matter of corporate responsibility. Responsible advertising requires them to take into account the impact of their messages on society. If it can be shown that these commercials are having a negative impact, the companies should, as a matter of good corporate citizenship, adjust when and where they are broadcast.

10. Constructive Compromise--As with most things in life, the solution to the problem Congressman Moran has identified probably lies in a compromise of some sort. Is it not reasonable for Congress to go back to the pharmaceutical industry and ask it to enforce its own self-regulatory code? Can't Congressman Moran enter into a constructive dialogue with the big drug companies to discuss this issue? Wouldn't that be more productive than a prolonged and costly legal battle which surely would ensue over the constitutionality of the law, should it pass?

In sum, there are many more arguments to be made against legislation that prohibits ED ads than those in favor. Now in the interest of full disclosure, I do advise advertising agencies on legal and legislative matters in Washington. But it seems to me, the solution here is more a matter of common sense conversation between policymakers and big pharma than anything else.

(c) 2009. All rights reserved