Editorial

On the FDA and doing what's right

2/11/01 -- On Sunday, Feb. 4th at the Cranberry Marketing Committee meeting, Ocean Spray executives and Ocean Spray members of the CMC were among those who attended a seminar conducted by Jere Downing of the Cranberry Institute on promoting the health benefits of cranberries. He repeatedly emphasized how important it was to assure that any health related studies on the benefits of cranberry juice be judiciously reviewed before they were used to promote cranberries. He stated in no uncertain terms how the industry could be damaged if the most rigorous standards weren't adhered to in the process of disseminating the results of scientific studies.

Unbeknownst to most present at this meeting, Ocean Spray had received a warning letter from the FDA on January 19th which admonished them to remove certain health claims from their  public web site. They were directed to respond within 15 working days lest they be liable for sanctions. According to the Patriot Ledger, Ocean Spray sent their response to the FDA just two days before, on Feb. 2nd. 

What could Ocean Spray's representatives have been feeling when Jere Downing cautioned the leadership of the cranberry industry about not overstating the health benefits of cranberries?  Did they feel a twinge of guilt for remaining silent when they could have offered a helpful "case in point" object lesson? 

Ocean Spray should make communications with the FDA public
and set an example by  their graceful compliance.

Ocean Spray has not made their letter to the FDA public. They should do so. So far we have learned from the Ledger article that Ocean Spray spokesman Chris Phillips said that " the company would consider its legal options because the FDA's interpretation imposes new restrictions on food companies' web sites... It may raise free speech issues." 

It is commendable that Ocean Spray is an advocate of free speech on the Internet. However, the issue here isn't free speech. The issue is assuring that the public, most of whom are not scientifically sophisticated, aren't misled by health claims made by food companies. It is wrong to allow all but the most rigorously proven claims of health and medical benefits for products to be used in labeling and in advertising. From a company perspective, promoting preliminary research results runs the risk that a claim may subsequently turn out to be incorrect. If this happens the credibility of the food company becomes questionable. And worse, for an entire industry, other health benefits of the product itself become suspect.

Why did the FDA choose the Ocean Spray web site as the target of their first warning letter asserting that when an Internet address is publicized on a label it becomes an extension of that label and is governed by the rules that apply to labeling? One reason might be that Washington politics played a role in this. Could this have been payback against Ocean Spray by the outgoing Democratic administration for the years of battling over the Ocean Spray label? Another reason might be that the grapefruit claims were particularly egregious because the average consumer reading them might be harmed. How many people know that grapefruit is one of the few foods*, and the only common fruit, that must be used with caution or not at all with certain medications? The FDA obviously felt very strongly about this (see excerpt).

Ocean Spray must quit the doubletalk and stop tilting at windmills.

Phillips is quoted in the Ledger as saying "If the science is clinical studies, we talk about it one way... If it's emerging science, we present it for what it is and no more...There's demand for this sort of information from consumers." Officials at the FDA are not going to appreciate this rhetoric. 

Ocean Spray should not try to fight the FDA on this interpretation of the labeling statutes. There already is an appropriate, and legal, vehicle for publicizing research that suggests or supports a growing body of scientific evidence of the healthfulness of cranberries. The Cranberry Institute has an excellent web site which is disseminating information about research in progress. Once there is something significant to report, press releases are the way to go. Good news about the health benefits of foods is still being enthusiastically reported in the media. When a health benefit of cranberries finally meets the FDA criteria to be included on a label and the Ocean Spray web site, it should be done with trumpets blaring. 

Industry spokespersons must be very precise in talking to the media. For example, a Patriot Ledger article about Ocean Spray white cranberry juice attributes the following to Chris Phillips: "The juice is made from green or white cranberries picked early before the skin reddens and has all the health benefits of regular cranberry juice." There are no studies that say that green or white cranberries have all the health benefits of regular cranberry juice.

Sometimes doing what is right means not playing politics.

It is difficult to believe that the attorneys at Ocean Spray want a law suit from a consumer who read about the benefits of grapefruit juice on their web site and thought it enhanced the effects of her cholesterol lowering medication, and then had a heart attack. For this reason alone, one would think they'd have complied immediately with the FDA letter and issued a public statement about the grapefruit juice interactions with certain medications. Of course this would have needed to come at a time right after the Annual Meeting, when the  company owed a dept of gratitude to the Ocean Spray grapefruit growers for voting the company slate in a proxy fight. 

Ocean Spray may not understand how major companies now want their web sites to be an extension of their labels. However, it is far more disturbing that they imply that the company may fight the FDA, as this quote from the Ledger suggests: