McNeil Consumer Healthcare addresses acetaminophen concerns on Tylenol.com
NEW BRUNSWICK, N.J. In the wake of the news around acetaminophen last week, McNeil Consumer Healthcare posted a public letter at www.tylenol.com to explain the news to Tylenol users.
“Recently, there have been reports about acetaminophen, the medicine in Tylenol, and the potential for liver damage if the medicine is misused or taken in overdose amounts,” the letter, signed by Edwin Kuffner, senior medical director, medical affairs at McNeil, opened. “As the makers of Tylenol, we share the FDA’s goal of helping to ensure that over-the-counter and prescription medicines are used safely and properly,” he said. “[But] Tylenol, when taken as directed, remains the safest pain reliever people can take.”
The letter goes on to explain that it’s inappropriate use of acetaminophen products, when patients consume more than the recommended dosage, that is linked to increased liver damage risk.
That message was replicated last week with full-page ads in USAToday, the New York Times and the Wall Street Journal, among other papers.
CRN criticizes CSPI’s allegations over increased health risks associated with selenium intake
WASHINGTON As part of its efforts to address misconception and misdirection around the safety and efficacy of dietary supplements, the Council for Responsible Nutrition on Tuesday issued a release criticizing the Center for Science in the Public Interest’s recent allegations that there are increased health risks associated with selenium intake.
“It is disappointing to read the kind of fear-mongering that is being attributed to the Center for Science in the Public Interest in connection with its campaign to clarify the permissible health claims that can be made for selenium and certain kinds of cancer,” stated Steve Mister, president and CEO, CRN. “Recently CSPI has been quoted as issuing statements like, ‘[selenium products] are dangerous to the health of men suffering from prostate cancer,’ ‘ may increase the risk of diabetes and hypertension,’ and that, ‘the [selenium] products pose a health risk to consumers because results from studies associate selenium intake with increased risk of developing diabetes and with increased risk of aggressive prostate cancer.’”
However, the authors of that study associating selenium with increased diabetes risk — the SELECT trial — “have themselves been very careful to state that any increased risk of diabetes that might have been associated with the SELECT trial was not statistically significant and may have been due to chance,” Mister said. “It is more than a little disingenuous to keep raising the specter of increased chance of diabetes from non-statistically significant data from a single study that may be due to chance.”
Likewise, CSPI has speculated about the dangers to men suffering from prostate cancer who supplement with selenium. CRN is not aware of any hard data that even remotely suggests that men with prostate cancer are turning to selenium as a cure or treatment, the association stated. Nor is there data that these men are forgoing their chemo-treatments or cancer drugs in favor of selenium.
The published study that CSPI cites in support of the allegations that selenium is associated with aggressive prostate cancer — Journal of Clinical Oncology, June 2009 — does not support that conclusion, Mister said.
“The real issue that is under scrutiny is whether the claim that selenium can reduce the risk of developing prostate cancer is adequately supported by the evidence,” Mister added. “CRN and CSPI can certainly disagree about that and whether particular claims appropriately communicate to consumers their risk of developing cancer; it would be entirely appropriate for CSPI to urge FDA to deny the claim while CRN argues that the data is sufficient to support such a claim. But it’s quite disturbing to see CSPI resorting to this kind of hyperbole to attract headlines and divert attention from the real issues.”
NAD recommends Removyl to discontinue certain advertising claims
NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Tuesday recommended that Removyl Corp. discontinue weight-loss claims in advertising for the Removyl Advanced Formula dietary supplement products, including: “Recent studies have shown that the combination of 13 known essential oils prevents fat from building in the body by stimulating the body to break it down and eliminate it on a daily basis;” “It is possible to lose up to 2 lbs. per day in the first three weeks, without any effort;” and “You are going to notice that your weight will have dropped by almost 1 lb. in as little as 8 hours.”
In this case, the NAD noted, the advertiser relied solely on studies on green tea extracts, not on the advertised product Removyl (the essential oils), to support its advertising claims. However, the NAD determined that none of the cited green tea studies supported the specific weight-loss claims being made.
Further, the NAD determined that there was insufficient evidence in the record to support rapid weight-loss claims. While there was limited evidence that certain ingredients in Removyl are recognized as possessing diuretic and laxative properties, there was no evidence that the amounts of these ingredients contained in Removyl would have such effects, and none of the evidence rose to the level that would support specific fast weight-loss claims. The NAD recommended that claims suggesting rapid weight loss be discontinued.
In response to the NAD’s opening letter, Removyl informed the NAD that it has suspended all advertising purchases for Removyl Advanced Formula, and that no further advertising would be booked in the future until the the NAD’s review was complete.
The company, in its advertiser’s statement, added that it has not offered the product for sale since April, although it has shipped remaining orders.
The review is a part of the NAD’s ongoing monitoring program in conjunction with the NAD’s initiative with the Council for Responsible Nutrition.