Bayer Diabetes Care updates devices under National Glycohemoglobin Standardization Program
TARRYTOWN, N.Y. Bayer Diabetes Care has successfully completed certification of its A1CNow+ and A1CNow Selfcheck devices under a tighter performance certification standard that went into effect Jan. 1.
The new performance certification standards applicable to devices that measure A1C (or glycated hemoglobin) as set by the National Glycohemoglobin Standardization Program (NGSP) changed to +/-0.75% A1C, 95% CI, 4-10.0% A1C range.
Bayer received a new NGSP certificate valid from July 1, 2010 through July 1, 2011. The previous criteria for last year’s NGSP certification was +/-0.85% A1C, 95% CI, 4-12.0% A1C range.
Report: J&J’s Lancaster, Pa., plant under fire
NEW YORK A third Johnson & Johnson manufacturing facility has come under Food and Drug Administration scrutiny following an inspection, according to published reports.
J&J confirmed it had received a Form 483 from the FDA regarding its Lancaster, Pa., plant, which is a joint venture between J&J and Merck Consumer Pharmaceuticals that manufacturers the heartburn remedy Pepcid.
J&J also revealed the company had received a grand jury subpoena from the U.S. Attorney’s Office in Philadelphia during its conference call on Tuesday, though declined to provide more information on that matter.
NAD scrutinizes Millenium Health’s cancer benefits claim for dietary supplement
NEW YORK The National Advertising Division of the Council of Better Business Bureaus has recommended that Millennium Health discontinue Internet advertising claims that state or suggest that Ellagic Acid 1000, a dietary supplement, treats or cures cancer.
The NAD also recommended that the advertiser discontinue using the inaccurate descriptors “antimicrobial” and “anticarcinogenic” to describe the product, and that the advertiser discontinue the “Cancer Prevention,” “What is Cancer?” and American Cancer Society links on its website.
NAD, the advertising industry’s self-regulatory program, reviewed claims for the product following a challenge by the Council for Responsible Nutrition.
Making disease-state claims, such as proposing a supplement may treat or cure cancer or provide anticancer benefits, also violates Food and Drug Administration statutes. According to the FDA website, “a product sold as a dietary supplement and promoted on its label or in labeling as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved — and thus illegal — drug. To maintain the product’s status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act of 1994.”
In its initial response to the NAD’s inquiry, Millennium Health represented that it had carried out an extensive revision of its website, Ellagic.net, and that it had removed all of the challenged claims. Notwithstanding, the advertiser cited research on Ellagic Acid that it maintained supported the general claims that Ellagic Acid is a powerful, unique antioxidant that provides certain anticancer benefits.
Specifically, Millennium Health cited a list of studies on Ellagic Acid contained in the Journal of Clinical Oncology, as well as several National Institute of Health links, as evidence supporting the anticancer benefits of Ellagic Acid.
Following its review of the advertiser’s evidence, the NAD noted that the cited studies were either conducted on animals or in laboratories, and were insufficient to support the types of “cancer” claims being made by the advertiser. The NAD stated that it found the “cancer prevention and treatment claims to be extremely troublesome, in light of the fact that there was no evidence that this product has been studied for its cancer prevention/cure benefits in humans.” Further, such claims “are dangerous in that they may cause consumers who purchase these products in reliance on such claims to forgo medical treatment.”
“We accept NAD’s decision in its entirety, which is fair and accurate,” responded Millennium Health in a statement addressed to the NAD.