
The Food and Drug Administration (FDA) has
warned pharmaceutical company QOL Medical that marketing emails it sent for its Sucraid product are false or misleading.
A letter sent by the FDA to the firm cites “claims and
presentation” that might seem quite typical to some consumers:
Try Sucraid
“Do you have patients suffering with unresolved IBS-like symptoms,
including gas, bloating, diarrhea, and/or nausea?”
“Could it be CSID?”
“Learn more about the only FDA-approved enzyme replacement for
the treatment of CSID…”
What was wrong with these promotional statements?
“These claims and presentations create a misleading impression about the indication for
Sucraid,” the FDA says. “Specifically, they imply that because of overlapping symptoms with Surcrase-Isomaltase Deficiency (CSID), Sucraid can be used to treat irritable bowel syndrome
(IBS), when this is not the case.”
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It continues that “the emails imply Sucraid can be used to treat all contributing factors of CSID, when this is not the case. Specifically, the
emails fail to provide material information regarding Sucraid’s full FDA-approved indication.”
We’re not qualified to assess the medical claims. But here’s one thing we
did note: “We acknowledge that the full indication is presented at bottom of the email with the important Safety Information; however, it is presented in small plain font, after intervening text
and eye-catching graphics and/or colors. Therefore, this is not sufficient to mitigate the misleading impression.”
Font size can normally be regarded as a creative issue.
“You want big? We’ll give you big.”
But here is one matter of concern: Certain risk information is omitted, including severe hypersensitivity reactions, increased blood
glucose concentration and dietary starch restriction.
“Furthermore, the presentation of risk information in the emails do not appear in a sequence that discloses risk information
in order of severity, and thus misleadingly minimizes the risks associated with Sucraid."
There is no legal threat stated. But the letter asks for a written response within 15 days.
“If you believe that your products are not in violation of the FD&C Act, please include in your submission to us your reasoning and any supporting information…”
Product? We thought this was about the promotional emails.
With the bad grammar, the FDA letter reads in spots as if it were written by AI. Maybe these guys are stretched too thin to
send a proper letter.
The letter was first reported by Fierce Pharma.