FDA stepped up enforcement, issued more warnings to the industry and consumers

If you've been following the FDA's enforcement actions lately, you may notice that the agency has been very busy dealing with recalls, warning letters, and new rules that would require tighter regulatory oversight of products.

For example, according to LA Times, warning letters for misleading labeling and other violations issued by the FDA's Center for Drug Evaluation and Research jumped from 24 in 2005 and 21 in 2006, to 103 in 2009.  Additional warning letters also come from FDA regional offices and from other agency offices responsible for the safety and effectiveness of food, biologics, medical devices, cosmetics and other products.

That new activity hasn't gone unnoticed in political circles.  David Acheson, the FDA's top food safety official during the George W. Bush administration, contends that the agency is overzealous in pursuing allegedly bogus health claims made by food producers.  However, he had to admit that "on balance, it's been mainly science."

I have advised many of my clients (especially small and medium sized businesses) that, no matter how "right" you think you are to do or say something (or how "wrong" you think the FDA is), you would have to stop doing or saying it once the FDA asked you to stop, unless you have the resources to fight it.  In light of the FDA's stepped-up regulatory activities, it is especially important to seek experienced FDA counsel in the early stage of product development to minimize your risks.

FDA revised selenium health claims, but would you want to use them?

Alliance for Natural Health US, a trade group who sued the FDA after the agency denied their health claim petition, announced last week that it has reached a partial settlement with the FDA regarding the case.

According to Natural Products Insider, the following claims may now be used on labels and in labeling of selenium-containing dietary supplements in the U.S. effective immediately:

• "Selenium may reduce the risk of prostate cancer. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of prostate cancer."
• "Selenium may reduce the risk of colon cancer. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of colon cancer."
• "Selenium may reduce the risk of bladder, colon, prostate, and thyroid cancers. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of these cancers."

Previously, one the claims read: "Two weak studies suggest that selenium intake may reduce the risk of prostate cancer.  However, four stronger studies and three weak studies showed no reduction in risk.  Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer."

The trade group asserted that the FDA's previous claim is at odds with the Supreme Court's mandate that there be a "reasonable fit" between the government's goal (of protecting public health and preventing consumer fraud) and the restrictions it imposes on commercial speech.  Specifically, the agency re-wrote the trade group's proposed claim, instead of inserting an appropriate disclaimer after it.  The new claims appeared to remedy that issue.

Although the new claims are shorter and can get the point across more directly, one has to wonder who would put the statement "FDA concludes that it is highly unlikely that" the claim is true on their products.

FTC has no business regulating speech from the heart, says POM Wonderful

Last week, the Federal Trade Commission (FTC) charged POM Wonderful, the maker of a brand of pomegranate juice, with making unsubstantiated health claims about its products.

The federal agency said the juice and supplements firm made "false and unsubstantiated claims that their products will prevent or treat heart disease, prostate cancer, and erectile dysfunction."  The complaint says the company "violated federal law by making deceptive disease prevention and treatment claims" with ads in the New York Times and other publications and on the Internet.

In an editorial published by the LA Times, Michael Hiltzik takes a closer look at POM's reactions to the charge, as well as the scientific research, which was funded by the company, behind the health claims.

It is not surprising that the people at POM are outraged by the charge and content that the federal government is infringing on their right of free speech.

The most interesting part of the editorial is perhaps POM's assertion that the company owner's (Lynda Resnick) statements about the product should not be taken as an "advertisement" and that since they were made in an interview, they are none of the FTC's business.

According to POM, Resnick is "talking about what she personally believes with respect to the science that she's seen. ... Lynda's not a doctor, she's not offering scientific opinion; she's speaking ... as an individual from the heart about what she believes."

A company generally cannot have someone say something for the company that it cannot say under FTC or FDA regulations.   Like Mr. Hiltzik, I am interested in seeing whether POM Wonderful can make that argument stick with the FTC.