Dietary supplement legislation receives support from CRN, NPA
WASHINGTON Sens. Tom Harkin, D-Iowa, and Orrin Hatch, R-Utah, on Tuesday introduced the Dietary Supplement Full Implementation and Enforcement Act of 2010, a piece of legislation designed to provide the Food and Drug Administration with additional enforcement resources.
Each of the leading trade associations representing the supplement industry issued their support behind the bill.
“[The Council for Responsible Nutrition] applauds Sens. Tom Harkin and Orrin Hatch for their efforts to fully fund, implement and enforce the Dietary Supplement Health and Education Act of 1994,” stated Steve Mister, CRN president and CEO. “CRN and its member companies have long advocated for more resources to help the FDA better enforce industry regulation, and this bill is a step in the right direction to making that happen.”
John Gay, executive director and CEO of the Natural Products Association added, “While some have called for additional regulations on supplements, Sens. Harkin and Hatch understand that the real need is to fully enforce the stringent statutes already on the books, to the full extent of the law. The way to get the bad actors out of the industry is by putting more cops on the street, plain and simple.”
This legislation reinforces the authority FDA has to regulate the supplement industry under DSHEA, and ensures the agency has additional resources to more fully implement that authority. The bill would provide FDA with additional resources over a five-year period to accomplish important regulatory mandates set out by DSHEA, including:
- Assuring that manufacturing facilities are GMP compliant through additional facility inspections;
- Calling on FDA to issue clear guidance for new dietary ingredients and the submission of these NDI notifications, as well as the criteria for establishing a reasonable expectation of safety for these ingredients;
- Implementing an annual registration process for supplement manufacturers, packers and distributors;
- Requiring more dialogue between FDA and the Drug Enforcement Administration so that anabolic steroids or their analogues do not reach consumers as a mislabeled supplement; and
- Developing appropriate consumer education initiatives that will create more informed supplement customers.
FDA: Prolonged PPI use may increase risk of bone fractures
SILVER SPRING, Md. Prolonged use of a common class of drugs for treating digestive problems may increase the risk of bone fractures, the Food and Drug Administration said Tuesday.
The FDA issued a warning to consumers and healthcare professionals based on a review of several epidemiological studies that long-term use of prescription and OTC proton-pump inhibitors or use of the drugs in high doses could increase the risk of fractures of the hip, wrist and spine. Information about the possible risks will be included on revised product labels for PPIs, the FDA said.
“Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton-pump inhibitors for one year or longer, or at high doses,” FDA division of gastroenterology products deputy director for safety Joyce Korvick said. “Because these products are used by a great number of people, it’s important for the public to be aware of this possible increased risk and, when prescribing proton-pump inhibitors, healthcare professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition.”
PPIs are used to great gastroesophageal reflux disease, ulcers, esophageal inflammation and heartburn. Prescription PPIs include AstraZeneca’s Nexium, which IMS Health ranks as one of the top-selling drugs in the world, with 2009 sales of $6.3 billion, and Takeda’s Dexilant (dexlansoprazole). OTC PPIs Prilosec OTC (omeprazole), marketed by Procter & Gamble, and Prevacid 24HR (lansoprazole), marketed by Novartis, under licenses from AstraZeneca and Takeda, respectively.
AstraZeneca spokesman Blair Hains told Drug Store News the company recently had received the notice from the FDA and would respond within the allotted 30 days.
“We’re all working toward the same thing,” Hains said. “We want prescribers and patients to have the best healthcare information that’s out there.”
Viral infection linked to juvenile diabetes
SAN DIEGO Researchers presented findings at the 110th general meeting of the American Society for Microbiology in San Diego that suggested an association between Type 1 diabetes and enteroviral infections.
Researcher Antonio Toniolo of the University of Insubria and Ospedale di Circolo in Verese, Italy, and colleagues tested the blood of 112 children at the time of time of diagnosis for the existence of enteroviral DNA. Low-level enteroviral infectivity and genome fragments were detected in 83% of Type 1 (juvenile) diabetes patients, compared with only 7% of healthy controls.
"We studied the possible association of enterovirus infections with Type 1 diabetes at time of diagnosis," said Toniolo. "Literature suggests that infection by different enteroviruses may be linked to the early stages of diabetes," although he warned that the data did not provide a "causal relationship," but suggested environmental factors may be involved.
Enteroviral infections, commonly found in infants and adolescents, cause such syndromes as hand-foot-and-mouth disease, polioviruses and coxsackieviruses.