Tag Archives: Health

New Guidance for Dietary Supplement Manufacturers

 The FDA today released new guidance for sellers of dietary supplements.  The guidance addresses how to determine whether an ingredient should be considered a New Dietary Ingredient (NDI), and the requirements for filing a pre-market NDI notification.  

FDA said another motivation for providing the guidance is to improve the quality and quantity of NDI notifications.  There are an estimated 55,600 dietary supplement products on the market, but FDA has only received about 700 NDI notifications since it began reviewing them 16 years ago.  Approximately 1,000 new dietary supplements are introduced to the market each year.   The low number of NDI notifications, plus FDA’s concern that some dietary supplements contain undeclared active ingredients, has prompted more attention on using these filings as a preventive monitoring tool. 

The agency is inviting response from the dietary supplements industry on today’s guidance.

Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA).  

Baxam Law Group advises clients on complying with the regulatory requirements for marketing of consumer products.

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Banaba and Diabetes

While traveling outside the US recently, a kindly woman encouraged me to investigate a natural product she said was a “miracle worker” for people managing diabetes as a chronic condition.  I forgot all about it for a while, but recently I was reading a supplement label and noticed that name again — Banaba extract.  Also known by a host of other names, such as Corosolic acid, Queen’s Crape Myrtle, Pride-of-India, and perhaps more formally as Lagerstroemia speciosa, this extract is being touted by many diabetes sufferers as a good naturopathic option.  According to other online sources, Banaba extract may also be helpful in weight loss.

Read more from WebMD about Banaba extract.

If you make or sell natural therapies, contact us learn more about how to label and market your products in compliance with federal rules and guidelines.

Photo from Dave’s Garden.

Baxam Law Group, LLC;  www.baxamlaw.com