SCPI calls Natrol’s Promensil ads ‘dishonest’
WASHINGTON The nonprofit Center for Science in the Public Interest on Wednesday filed a claim to the Food and Drug Administration that the red-clover dietary supplement Promensil, distributed by Natrol, “is being deceptively marketed to women for the relief of hot flashes, night sweats, and mood swings,” the organization stated.
“Natrol’s ads for Promensil are some of the most dishonest we’ve seen for a dietary supplement in a while,” stated CSPI senior nutritionist David Schardt. CSPI conducted a detailed analysis of the scientific research on Promensil, the organization stated, and how it doesn’t support Natrol’s claims. CSPI’s letters to the FDA ask that Natrol reimburse deceived consumers, run corrective advertising to set the record straight, and pay a fine.
In response, Natrol today issued a press release outlining a published clinical treatment protocol that recommends supplementation with red clover isoflavones for women experiencing menopause symptoms.
According to the company, the protocol was developed by physicians and other healthcare professionals from the United States, United Kingdom, Canada, Australia and The Netherlands, and recommends supplementation with red clover isoflavones as a complementary therapy for treating mild-to-moderate menopause symptoms, as well as for treating severe symptoms when hormone replacement therapy is contraindicated.
“We have long had confidence in the significant body of clinical research indicating Promensil provides benefits for menopausal women by offering a unique isoflavone ratio that is a safe alternative to HRT,” stated Natrol vice president of research and development Michael Yatcilla. “Promensil can help relieve the frequency and severity of hot flashes, and promote breast and heart health, as well as emotional well-being.”
Continua Health Alliance unveils guidelines for health and fitness services
PORTLAND, Ore. The Continua Health Alliance, a group of technology, medical device and health and fitness industry leaders, on Wednesday unveiled the key components of its first set of technical guidelines to help establish a market of connected personal health and fitness products and services.
Once implemented, Continua Health Alliance compliant products can be used in conjunction with one another—linking blood pressure monitor readings with body mass index readings, for example.
The first set of guidelines, due out early 2008, are based on proven connectivity standards and will help to increase assurance of interoperability between devices, enabling consumers to share information with caregivers and service providers more easily.
The Version One standards include the Bluetooth Medical Device Profile Specification (Bluetooth SIG), USB Personal Health Device Specification (USB Forum), ISO/IEEE 11073 Personal Health Device Specifications (IEEE), and Health Level 7 for integration with standards-based electronic health records (EHR). The comprehensive set of guidelines will help improve the quality of care by empowering consumers and their healthcare providers to more simply share information through common communication channels such as telephones, cell phones, PCs, TV set top boxes, as well as other dedicated health devices.
“Continua is committed to empowering consumers and patients world wide, to take an active role in their own care through the use of technology,” stated Dave Whitlinger, chairman of the Continua Health Alliance. “Continua’s membership will utilize the Version One Guidelines to create connected health devices and services that provide individuals the tools they need to proactively manage their health.”
Continua Health Alliance also announced Wednesday it is working with Abt Associates on a research project targeting reimbursement policy. Abt Associates will assist in cataloging, synthesizing and assessing all telehealth studies and the peer-reviewed cost-effectiveness literature. This work will help Continua determine strategies for initiating increasing telehealth cost effectiveness, initiating quality improvement studies and for securing reimbursement for telehealth products and services.
Manufacturers of products that meet these guidelines will be permitted to use the Continua Health Alliance certification logo to promote their products.
In its first year, Continua has grown from 22 to 133 member companies, with its efforts focused on a continuum of life and care methods, particularly chronic disease management, maintaining healthy independence for the aging, and proactive health and fitness. Interoperability allows patients to use the best devices for their individual needs and provides immediate access to health information. These standards recognize devices that can work together and communicate in each of these three fields, helping maximize positive health outcomes.
In the field of chronic disease management, a network of readily connected health and medical devices will allow people with diabetes or other chronic diseases to share vital information with their doctors. These interoperable devices include blood glucose tests, blood pressure monitors, pulse oximeters and other basic vital sign monitors. Devices such as motion sensors, medication reminders and emergency response services ease the burden on family and professionals who provide care for the aging.
Abbott launches NutriPals snack bar for kids
COLUMBUS, Ohio Abbott Nutritionals on Wednesday launched PediaSure NutriPals Fruit Bars, a kids’ snack bar made with one serving of real fruit in every bar.
A recent study shows only 39 percent of moms believe their children are getting enough fruit in their diets. Additionally, moms are concerned that their children may not consume all the essential vitamins, minerals and nutrients they need each day.
To that end, NutriPals Fruit Bars are low-fat, healthy snacks, and they contain no high-fructose corn syrup, hydrogenated oils, trans fat or preservatives, Abbott stated. Each 150-calorie bar is a good source of protein, fiber and more than 20 vitamins and minerals. “For most parents, it’s a challenge to get your kids to eat the bananas or apples you pack in their lunch boxes,” stated Jeff Boutelle, division vice president and general manager of pediatric products, Abbott Nutrition. “New NutriPals Fruit Bars are a convenient way to get more real fruit into their diets.”
PediaSure NutriPals Fruit Bars are now available in the baby/toddler aisle at most major retailers, alongside other NutriPals products. NutriPals Fruit Bars come in three flavors—strawberry, mixed berry and blueberry—and the suggested retail price is $5.49 for a box of six bars.