Food And Drug Administration

Florida start-up CareMundi brings US supplements to Brazilian buyers

Florida start-up CareMundi brings US supplements to Brazilian buyers

By Adi Menayang

In the dietary supplement world, Brazil is notorious as being a tough market to get into. But there is demand for US-made products in the country, and one-year old start-up CareMundi, an online sales platform, is providing a bridge for US supplement makers...

Eight of 11 ill people interviewed said they had consumed kratom. Picture: iStock/frank600

Kratom linked to multistate Salmonella outbreak

By Joseph James Whitworth

The US FDA and CDC are advising consumers to avoid kratom and kratom-containing products due to a link with a Salmonella outbreak that has sickened 28 people in 20 states.

Letter to FDA seeks clarity on agency’s resources, enforcement aims

Archive article of the week

Letter to FDA seeks clarity on agency’s resources, enforcement aims

By Hank Schultz

Three members of Congress have sent a letter to the US Food and Drug Administration requesting specifics on how enforcement funds are allocated. The three lawmakers are among those the Council for Responsible Nutrition has worked closely with on regulatory...

Under the radar ingredient raises warning flags in Canada

Under the radar ingredient raises warning flags in Canada

By Hank Schultz

Products containing lithium orotate—a salt of a mineral that has been used to treat psychiatric disorders—have been the subject of two Health Canada warnings this year. Yet similar products are freely for sale south of the border, and don’t seem to be...

ODI docket comments:  Make the list big, or don’t make it at all

Archive article of the week

ODI docket comments: Make the list big, or don’t make it at all

By Hank Schultz

Will compiling an official list of Old Dietary Ingredients ultimately be worth the effort? Maybe, but the resulting list must be expansive rather than restrictive to be of much use, most stakeholders agree.

Repeat offender gets $3.7 million FTC fine over disease claims

Repeat offender gets $3.7 million FTC fine over disease claims

By Hank Schultz

A dietary supplement company that has received a previous warning letter from the Food and Drug Administration has agreed to a $3.7 million fine to settle a case brought by the Federal Trade Commission and the State of Maine for making over the top disease...

© Getty Images / Aryut

Archive article of the week

‘Needed’: FDA issues draft guidance for best practices for GRAS panels

By Stephen Daniells

Hailed by experts as ‘needed’ and ‘significant’, the US Food and Drug Administration has issued draft guidance on best practices to follow when convening a panel of experts to evaluate whether a substance is “generally recognized as safe” (GRAS).

FDA hardens stance against use of CBD in supplements

FDA hardens stance against use of CBD in supplements

By Hank Schultz

The Food and Drug Administration’s attitude that CBD does not belong in dietary supplements seems to have hardened, judging by the wording of four warning letters issued this week.

ITC declines to hear Amarin's fish oils complaint

ITC declines to hear Amarin's fish oils complaint

By Hank Schultz

The US International Trade Commission has decided not to hear a case in which the fish oil drug maker Amarin sought to prevent the import of some omega-3 dietary supplements.

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