2008 round-up: US regulation

Related tags Dietary supplement Fda

NutraIngredients-USA’s ongoing review of the articles that sparked most interest in you the readers continues today with the most viewed pieces in the regulatory area.

The top story involved the spectacular demise of Steve Warshak, the founder of Berkeley Premium Nutraceuticals – maker of the high-profile male enhancement supplements promoted in TV commercials by Smiling Bob.

 

Warshak was handed a 25-year jail sentence and his company ordered to forfeit $500 million after he was found guilty on 93 counts of conspiracy, fraud and money laundering.

Veteran Colorado-based food-industry lawyer, James R Prochnow, of the firm Greenberg Traurig, called the verdict “historic”​ in its harshness.

To read the story click here​.

In at number two was a stevia story Stephen Daniells took from Supply Side West in October. He learned that a Washington DC law firm had petitioned the FDA to prevent the addition of steviol glycosides to food.

The petition focused on § 301(ll) of the Federal Food, Drug, and Cosmetic Act (FFDCA), and was made on the grounds that steviol glycosides have been studied for therapeutic uses, such as effects on blood pressure and blood sugar levels, with clinical trials supporting these therapeutic uses.

To read the story click here​.

 
 

A piece on guidance issued by the FDA to help smaller companies comply with the labeling of antioxidant products and high potency products was the third most popular story.

The Small Entity Compliance Guide sets out the agency’s position “in plain language” ​regarding the use of the nutrient content claims on dietary supplement products.

To read the story click here​.

The controversial area of contamination in sports supplements provided the fourth most popular story, after a high-profile Olympian tested positive to a banned substance and blamed the dietary supplements she was taking.

Clenbuterol, used by the likes of Britney Spears, was the substance in question and American swimmer Jessica Hardy blamed the transgression on the dietary supplements she was taking and disassociated herself from the company that made them.

To read the story click here​.

Rounding out this round-up was a popular round-up of 2008 FDA actions against products that overstepped the fine line between function and pharmaceutical.

To read the story click here​.

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