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.
Pharmavite names CEO
NORTHRIDGE, Calif. Pharmavite on Tuesday named Doug MacLean as the company’s new CEO.
MacLean comes to Pharmavite from TalkingRain, a Seattle-based beverage company focused on health-conscious consumers, providing natural waters and functional beverages, where he most recently served as CEO. During his tenure, he led the organization from a start-up to a successful, independent beverage company.
At Pharmavite, McLean’s strategic priorities will include accelerating the growth of new products in the United States in conjunction with Pharmavite’s parent company, Otsuka Pharmaceutical Corporation, and maintaining a continued focus on the financial health and effectiveness of Pharmavite’s overall business.
MacLean officially will join Pharmavite June 1.
Web-based tools, at-home monitors aid blood pressure management
DENVER The use of at-home blood pressure monitors and Web-based reporting tools that connect clinicians and patients via the Internet appears to significantly improve patients’ ability to manage their high blood pressure to healthy levels, according to research from Kaiser Permanente released Friday.
“While more research is necessary, our study suggests that using technology to engage individuals in their care at home may be a better way to help patients achieve a healthy blood pressure,” stated lead author David Magid, Kaiser Permanente senior scientist.
The study, led by Kaiser Permanente Colorado in collaboration with the American Heart Association and Microsoft, involved 348 patients with uncontrolled hypertension, ages 18 to 85 years.
Participants were randomized to a usual care group or a home monitoring group. All patients had their blood pressure measured in the medical office at the start of the six-month study. The usual care group was managed in a typical model that involved checking blood pressure during office visits.
The home monitoring group used an at-home blood pressure device that uploaded data to the patient’s account in Microsoft HealthVault, a security enhanced, Web-based data storage platform. At the time of entering the study, the participants opted into a Kaiser Permanente application that automatically transferred the home blood pressure readings to Kaiser Permanente’s electronic disease registry. Kaiser Permanente’s clinical pharmacists used the computerized registry to monitor readings and consulted with patients to adjust their antihypertensive medications based on proven protocols. Connected to HealthVault, patients were able to manage their data using Heart360, a free online tool provided by the American Heart Association.
At the start of the study, the average systolic blood pressure was 149 mm Hg in the home monitoring group and 145 mm Hg in the usual care group. At six months, patients in the home monitoring group were 50% more likely to have their blood pressure controlled to healthy levels compared to the usual care group. Similarly, a significantly greater decrease in systolic blood pressure at six months occurred in the home monitoring group (-21 mm Hg) versus the usual care group (-9 mm Hg).
“While the in-person doctor-patient relationship will always be a cornerstone of care, one day the use of coordinated, secure health information technologies based at home or work could complement visits in a medical office,” noted coauthor Kari Olson, a clinical pharmacy specialist at Kaiser Permanente Colorado.
Added Peter Neupert, corporate VP of the Health Solutions Group at Microsoft, “Engaging patients with tools that make health management more accessible is a critical step in addressing the alarming growth of chronic diseases and associated increase in costs. The preliminary results of this clinical trial are significant and demonstrate how cost-effective and flexible technology solutions can encourage patients to be active partners in their health and help decrease their risk for life-threatening, acute care incidents.”