FDA issues warning letter to Abbott Diabetes Care manufacturing plant
ROCKVILLE, Md. The Food and Drug Administration earlier this week posted a July 2 warning letter addressing quality concerns at an Abbott Diabetes Care manufacturing plant.
The warning letter outlined some of the specific violations of good manufacturing practices for the manufacturer of the FreeStyle blood glucose meter, including not following through on reports concerning empty blister packs being produced on the Noack Blister Packer at one of Abbott’s establishments. Similarly, an exception report initiated on April 8, 2008, for scratches on FreeStyle Lite strips was closed with no corrective action or effectiveness check, the agency stated.
Abbott is working with the FDA to address the agency’s concerns.
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.