Scientific support and regulatory guidance to get nutraceutical
finished products or raw materials ready for the US market.

Understanding the rules governing dietary supplements with regards to claims

A dietary supplement marketer cannot base claims on human studies where the outcomes are improvement of disease symptoms or prevention of diseases.  The law that is enforced by FDA dictates that a dietary supplement is not indented to diagnose, treat, … Continue reading

Think Twice before you develop an Energy Drink

You may want to read this article before you start your development work.  

FDA WILL INVESTIGATE ADDED CAFFEINE IN FOODS

On April 30, FDA announced via Michael Taylor, Deputy Commissioner of Foods, that the agency was starting a new review of caffeine in conventional foods. This was ostensibly triggered by the recent launch of Alert Energy gum by Wrigley. Caffeine … Continue reading

Latest news with regards to New Dietary Ingredients (NDI) Guidance

Senators Hatch and Harkin met with Commissioner Hamburg, Deputy Commissioner for Foods (Mike Taylor), and Assistant Commissioner (Jeanne Ireland) to discuss concerns and specific recommendations with respect to the Draft NDI Guidance.  During the meeting, five issues were specifically raised: … Continue reading

Deadly Energy drinks labeled as dietary supplements

Below is the link to a news report and letter from Senator Durbin to Commissioner Hamburg.  The topic is the regulation of energy drinks.  This letter was triggered by the death of a 14-year-old girl who allegedly drank two 24-ounce … Continue reading