U.S. Food and Drug Administration
CHPA Responds to AMA Policy Calling For Increased Regulation of Dietary Supplements
At the Special Meeting of the American Medical Association (AMA) House of Delegates, physicians adopted new policy, which expands upon the AMA’s existing policy to call for more stringent federal regulation of dietary supplements—including increased oversight of manufacturing, marketing, product labeling and adverse event reporting. Under the new policy, the AMA strongly urges Congress to ...
Oleandrin Not to be Used as a Dietary Supplement Says FDA
On Sept. 4, the U.S. Food and Drug Administration (FDA) rejected an application to market Oleandrin as a dietary supplement, weeks after MyPillow CEO Mike Lindell promoted the extract as a potential treatment for the coronavirus to President Donald Trump and White House officials, according to Forbes. The FDA concluded that Oleandrin cannot legally be considered ...
New Hampshire Joins List of States to Propose CBD Regs
As the U.S. Food and Drug Administration (FDA) continues to defy mounting requests from the U.S. Congress and the natural products industry to provide science-based and public health regulations for CBD, more states are rushing in to fill the vacuum, according to the Natural Products Association (NPA). New Hampshire recently joined Virginia, Texas and Hawaii ...
Dietary Supplement Usage Up Dramatically During Pandemic, New Ipsos-CRN Survey Shows
The Council for Responsible Nutrition (CRN) has issued results of a COVID-19-focused consumer survey that discovered more than two in five (43 percent) of dietary supplement users have changed their supplement routines since the start of the pandemic. Among those who altered their regimens due to COVID-19, 91 percent report increasing their supplement intake which ...
NPA Proposes Streamlined Data Sharing at FDA
The Natural Products Association (NPA) outlined a streamlined process to facilitate data sharing within the agency in comments to the U.S. Food and Drug Administration (FDA). Specifically, NPA suggested sharing data from the Office of Dietary Supplement Programs on structure/function claim notifications, new dietary ingredient (NDI) notifications, current good manufacturing practice (cGMP) inspections and certificate ...
Comar to Expand East Coast Footprint
Comar (Voorhees, NJ), a premier health care plastic packaging, device and component supplier, has announced a major capacity expansion of its Buena plant operations by building a new offsite location in Vineland, NJ. The new 159,000-square-foot facility in Vineland is a 20-minute drive from the current facility, will be ISO 13485 certified, cGMP (current good ...
Moderna and Lonza Join to Manufacture Moderna’s Vaccine Against Novel Coronavirus
Moderna, Inc., (Cambridge, MA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, and Lonza Ltd. (Basel, Switzerland) have announced a 10-year strategic collaboration agreement to enable larger scale manufacture of Moderna’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2) and additional ...
USP Offers Hand Sanitizer Toolkit in Response to COVID-19
The U.S. Pharmacopeia (USP) is offering an online toolkit with guidelines from major public health organizations on compounding alcohol-based hand sanitizers and the preparation of hand sanitizers by manufacturers, pharmacies and other facilities. The toolkit was developed to help organizations meet the demand for these products, as shortages of commercially manufactured sanitizers have occurred. The toolkit includes ...
Dietary Supplements Regulatory Summit Rescheduled
The 2020 Dietary Supplements Regulatory Summit (DSRS), originally set for May 27, has been rescheduled for Wednesday, Sept. 16, at the same venue, the Mayflower Hotel, in Washington, D.C. All existing registrations and pricing will be honored. New, discounted hotel booking information will be forthcoming shortly. “The five trade associations hosting the summit look forward ...
Natural Ingredient Suppliers and Manufacturers Adjust to COVID-19 Fight
With the number of cases of the Coronavirus (COVID-19) growing by the day and a number of states enforcing “shelter-in-place” orders, natural product manufacturers and ingredient suppliers are adjusting their practices to meet the new realities of working during a pandemic. Guidance from the Department of Homeland Security (DHS), and President Trump’s declaration that workers ...
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