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Oleandrin Not to be Used as a Dietary Supplement Says FDA

by Shari Barbanel | September 10, 2020

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

by Shari Barbanel | September 8, 2020

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

by Shari Barbanel | August 25, 2020

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

by Shari Barbanel | August 3, 2020

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

by Shari Barbanel | June 3, 2020

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 ...

ACG Receives Certification For its “Clean Label” Capsules

by Shari Barbanel | May 27, 2020

ACG (Mumbai, India), a supplier of fully integrated solutions to the global pharmaceutical and nutraceutical industry has received a certification of compliance from Clean Label Project for its ACGcaps H+. ACG Capsules has been recognized for its “clean capsule” design and manufacture and with this accreditation it has become the world’s first capsules to receive ...

Moderna and Lonza Join to Manufacture Moderna’s Vaccine Against Novel Coronavirus

by Shari Barbanel | May 5, 2020

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

by Shari Barbanel | April 13, 2020

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 ...

The ABH Nature’s Products Recall—Lessons for Own Label Distributors

by Marc Ullman | April 9, 2020

On Jan. 21, 2020, ABH Nature’s Products, Inc., ABH Pharma, Inc., and Stocknutra.com, Inc. (collectively “ABH”) announced an unprecedented recall covering in excess of 1,200 products marketed by more than 800 different own label distributors (OLD—companies that hire a contract manufacturer to produce branded products for them). This action came as a result of an ...

Dietary Supplements Regulatory Summit Rescheduled

by Shari Barbanel | March 26, 2020

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 ...

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