FDA targets dietary supplements maker for selling unapproved, misbranded drugs
SILVER SPRING, Md. The Food and Drug Administration on Wednesday announced that Toby McAdam and Greta Armstrong, doing business at Rising Sun Health and The Center for Complementary and Alternative Health of Livingston, Mont., have signed a consent decree that prohibits them from manufacturing and selling unapproved new drugs and adulterated or misbranded dietary supplements in violation of the law.
Prior to entry of the consent decree, Rising Sun manufactured and distributed a variety of unapproved new drugs under such names as Black Salve, Cansema and Can-Support. These products included topical salves purported to treat skin cancer, as well as oils and capsules claimed to be therapies for other serious diseases, such as breast cancer, asthma, anemia and epilepsy. Rising Sun misbranded many of these unapproved new drugs as dietary supplements.
“The FDA will not tolerate unsubstantiated health or disease claims that may mislead customers,” stated Deborah Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that consumers do not become victims of false cures.”
Under the consent decree, Rising Sun agreed to stop making and selling unapproved new drugs and products with unauthorized health claims. Rising Sun also agreed to hire an independent expert to review the claims made for future products and to certify that all violative claims have been omitted. The FDA can order Rising Sun to stop manufacturing and distributing any product that fails to comply with the consent decree or the Federal Food, Drug, and Cosmetic Act. The consent decree also provides for damages to be assessed against Rising Sun in the event of such violations.
The consent decree was filed in the U.S. District Court for the District of Montana and is subject to court approval.
H.D. Smith subsidiary launches new website
WOOD DALE, Ill. Smith Medical Partners, a business focused on specialty pharmaceutical distribution and solutions, announced the launch of its new company website.
The H.D. Smith subsidiary said its new site, Smpspecialty.com, features a user-friendly platform that includes audience-specific landing pages, including relevant products and FAQs tailored for unique segments of the healthcare industry.
Additionally, the site also will feature Smith Medical Partners news, reimbursement announcements, recall postings and industry developments, as well as e-newsletters that are tailored for multiple specialty practices, placing Smith Medical Partners customers among the first to receive details on new product launches, special purchasing opportunities and program information.
“Our online visitors will now experience a more comprehensive and vibrant view of Smith Medical Partners,” said Smith Medical Partners VP David DuRoss. “We have taken a strategic approach to providing rich content in an accessible and streamlined layout.”
A&D Medical rolls out new monitoring devices
SAN JOSE, Calif. A&D Medical on Wednesday introduced three new wireless telehealth and wellness devices featuring ANT technology.
A&D Medical’s monitoring devices with ANT wireless technology are essential feedback components for wellness coaching and health tracking, the company stated. Suitable for Web-based employee health programs, disease management, prevention programs and consumer wellness solutions, A&D Medical’s ANT devices enable a richer, more data-driven experience for both program administrators and end users.
These three A&D Medical products are designed for use with both mHealth and eHealth applications. Using ANT technology, the new products include a tri-axial activity monitor, precision personal health scale and an automatic blood pressure monitor. Each of these products feature an ANT wireless radio with automatic data transmission for seamless health metrics tracking.
ANT is a proven protocol and silicon solution for ultra-low-power practical wireless networking applications. It is designed for ease of use, efficiency and scalability with an installed base of more than 11 million nodes to date.