CRA urges supplement and food companies to keep record of dietary supplement ingredients
WASHINGTON Responding to a recent Food and Drug Administration decision that defines pyridoxamine dihydrochloride, a form of vitamin B6, as a new drug, the Council for Responsible Nutrition reiterated its position that vitamin B6 has a long history sold as a dietary supplement.
“FDA’s decision suggests that companies need to produce even more extensive evidence supporting an ingredient’s marketing as a dietary supplement, including catalog and business records from more than 15 years ago,” stated Andrew Shao, CRN’s VP scientific and regulatory affairs. “Demanding that industry maintain these records, but failing to work with industry to develop an agreed-upon list of ‘grandfathered ingredients,’ places more burden on dietary supplement companies to be sure that they can substantiate that an ingredient has in fact previously been marketed as a dietary supplement.”
The FDA’s decision precludes any dietary supplement manufacturer from marketing pyridoxamine without first obtaining FDA approval through a new drug application. CRN has argued that pyridoxamine has been on the market as a supplement even prior to the passing of the Dietary Supplement Health and Education Act. Under DSHEA provisions, an ingredient that has been sold as a supplement prior to being submitted as a new drug can continue to be sold as a supplement. Conversely, an ingredient cannot be marketed as a supplement following the submission of an NDA.
“The Agency’s decision on pyridoxamine could set a precedent for the status of other dietary ingredients to be challenged,” Shao suggested. “As such, CRN strongly encourages supplement and food companies to keep careful records of ingredients and marketing materials to ensure that the ingredients that they are using and marketing can continue to be marketed as dietary supplement ingredients under the law.”
Vestcom announces continued expansion of Healthy Aisles in-store marketing
LITTLE ROCK, Ark. Vestcom International, a provider of customized shelf-edge marketing solutions to retailers and brand manufacturers, on Wednesday announced the continued expansion of its successful health and wellness in-store marketing program, Healthy Aisles.
Vestcom’s program gives retailers the opportunity to add value to the shopping experience by providing quick and simple health and nutritional information that can be delivered via customized shelf labels, in-store kiosks, customer newsletters, circular and promotional advertising, Web-based applications, aisle experts and more.
“Expanding our Healthy Aisles program marks another step forward in our commitment to providing retailers with integrated shelf-edge marketing solutions that make healthy products easily identifiable for shoppers with specific dietary needs, or those wanting a healthier diet,” stated John Lawlor, EVP and chief communications officer of Vestcom. “Healthy Aisles makes it easy to connect shoppers to the information and expertise they need to make the choices they’re looking for quickly and accurately.”
As part of its expansion, Vestcom is working with Boston-based Joslin Diabetes Center to provide expanded data-driven health and wellness information on its shelf labels for select programs.
AirWare’s Brez nasal breathing aids now available at Rite Aid, independent pharmacies
SCOTTSDALE, Ariz. AirWare on Wednesday announced the availability of its Brez nasal breathing aids, a device that fits inside the nose that reduces snoring and improves sleep quality, nationally through Rite Aid.
Brez, available in three sizes, inserts easily into the nose and gently lifts, expands and supports the interior walls of the nasal passages to reduce the resistance of airflow. Brez has been reviewed and categorized as a Class I exempted medical device, based on Food and Drug Administration definitions, for marketing as an over-the-counter treatment to help relieve symptoms for multiple conditions related to impaired breathing, such as snoring, congestion due to the common cold or allergies and deviated septum.
In addition to Rite Aid, the product is available at several independent pharmacies nationwide.
“We’re pleased to begin our product launch with Rite Aid and independent pharmacies as our partners.” stated Mindi Osborn, AirWare president and CEO. “Brez is different than anything else on the market today because it effectively conforms to the user’s anatomy to provide a proactive, non-pharmacological solution to snoring.”
Data from an independent clinical study involving 26 snorers (12 men and 14 women) with snoring (non-apneic) bed partners showed that those who used Brez experienced a 52% decrease in snoring events from an average of 1,247 to 654. Snorers who used the device had only a 22.4% likelihood of persistent snoring and disturbing their bed partner’s sleep compared with their pre-treatment scores of 100%.
“I am impressed by the independent clinical data showing Brez usage resulted in a significant reduction of more than 50% of snoring events. Equally interesting, 88% of bed partners reported improved sleep quality when the product was used by the snorer,” stated George Gwinn, clinical investigator for PsyPharma Global, and allergy and pulmonary specialist. “Each day, pharmacists nationwide serve as front-line healthcare providers to help consumers deal with issues such as snoring. Based on these data, it appears that Brez may be an innovative solution that pharmacists can recommend.”