The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: David Kessler

FDA Has It In for Double Vowels: Cheerios, Google Ads Targeted

Cheerios picThe FDA, you may have heard, has told General Mills that the statement “clinically proven to help reduce cholesterol” on Cheerios boxes “cause[s] it to be a drug” and, therefore, that Cheerios “may not be legally marketed with the above claims in the United States without an approved new drug application.”  Ouch.

This follows a crackdown by the FDA on Google search advertisements bought by pharma companies, which do not contain the mandated risk information.  Since the risk info would never fit within the 95-character limit of the ads, the ads link to the product websites, which do provide the required risk disclosures. “Immediately cease,” says the FDA.

Chris Morrison at the In Vivo Blog has an interesting theory explaining why this is good news for the industries regulated by the FDA:

[T]he more the public views the head of the agency as a tough, anti-industry regulator, the more ambitious the agency can be in taking on initiatives that benefit the regulated industries.

Chris draws a parallel to the actions of former FDA commissioner David Kessler, appointed in 1990, who seized a huge quantity of Citrus Hill orange juice from Procter & Gamble, claiming that the “fresh” appellation could not be applied to juice from concentrate, which Chris says,

set the tenure for Kessler’s term and gave him a platform and reputation of [a] decisive regulator from which to undertake a range of initiatives at FDA – including getting user fees for drug approvals and speeding approvals of AIDS drugs.

I agree that “[t]he publicity [from the Cheerios letter] can re-establish FDA in the public’s eye as a force that is willing to take on big commercial products,” but I’m not sure it’s a tactical move.  It may just be the more aggressive regulatory instincts of the Democratic appointees.

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