CinSulin launches concentrated cinnamon extract into food, drug, mass
ATLANTA — CinSulin, based in Issaquah, Wash., is in the process of launching a cinnamon water extract to help maintain healthy blood-glucose levels for patients with prediabetes or Type 2 diabetes.
The extract contains a concentrated cinnamon extract through a proprietary process that separates the water-soluble components from unwanted fat-soluble components. The result is an extract that is on average 10 times stronger than the average cinnamon supplement, the company stated.
According to the company, the water extract of cinnamon has been studied in five human clinical trials to prove its effectiveness and safety, all of which have been published or presented in peer-reviewed journals and at scientific meetings.
The initial launch includes three SKUs: the flagship One Per Day CinSulin that features a one capsule-per-day regimen, an Advanced Strength CinSulin that is formulated with vitamin D3 and a Healthy Weight CinSulin that contains green tea and coffeeberry extracts to help promote healthy weight.
The products ship Feb. 1 and were showcased for buyers last week at the ECRM Vitamin, Diet & Sports Nutrition EPPS conference here.
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PMD launches first personal spirometer
ALLENTOWN, Pa. — Medical device maker PMD Healthcare has launched what it calls the first personal spirometer to monitor lung function, the company said.
PMD, based in Allentown, Pa., announced the launch of the Spiro PD, which recently received approval from the Food and Drug Administration. The device is designed to enable patients with such lung diseases as asthma, chronic obstructive pulmonary disease, cystic fibrosis and lung transplants "easily and accurately" monitor lung function anytime and anywhere.
"With the increase in prevalence of emergency room visits and hospitalizations for asthma and other pulmonary problems in the U.S., the availability of Spiro PD is especially significant," World Allergy Organization board member and University of Tennessee Health Sciences Center clinical professor Michael Blaiss said. "This new device allows patients and parents of young children with lung disease to know exactly how their condition is doing at any time, enabling patients to have a more active role in controlling their lung health and potentially identifying problems before the need for costly emergency treatment."
NARB upholds Advil’s challenge of Excedrin’s faster-relief claims
NEW YORK — The National Advertising Review Board on Tuesday recommended that Novartis Consumer Health discontinue advertising claims that the company’s Excedrin Extra Strength product starts relieving headache pain faster than Advil.
The claims at issue were initially challenged before the National Advertising Division of the Council of Better Business Bureaus by Pfizer Consumer Healthcare, makers of Advil.
NAD determined that Novartis did not provide a reasonable basis to support those claims, the review organization stated. NARB noted in its decision that when efficacy claims are made for pain-relief medication, “those claims must be supported by at least one adequate and well-controlled scientific study that measures efficacy in treating the type of pain for which efficacy is claimed — e.g., substantiation for claims involving relief of tension headache pain should include at least one scientific study that evaluates efficacy in treating tension headache pain.”
In this case, Novartis offered as support for its claims studies related to migraine and dental pain, as well as one study — the “201 study," which evaluated speed of relief in treating tension headaches.
The panel noted that the "201 study" focused on the following “four analgesic variables” during the first hour after ingestion of the test medication:
Time to at least half relieved pain;
Time to complete pain relief;
Weighted sum of pain intensity difference scores; and
Time to meaningful pain relief.
The study found no statistically significant differences between subjects who received Excedrin and subjects who received Advil with respect to the first three variables. While a statistically significant difference of 5.1 minutes was arguably found in looking at median time to achieve meaningful pain relief within the first hour, no statistically significant differences were found at any of the 10-minute measurements except for the 40-minute measurement, NARB noted.
Novartis, in its advertiser’s statement, stated the company “disagrees with the NAD and NARB conclusions regarding the scientific substantiation in issue but will comply with the recommendations made."