The decision of the U.S. Food and Drug Administration (FDA) has not been officially announced as of this column’s writing, but Senate staff confirms that, on June 19th, Senators Tom Harkin and Orrin Hatch were informed in a personal meeting with FDA Commissioner Margaret Hamburg and Deputy Commissioner Mike Taylor that a revision of the FDA’s Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues may be attempted in the future.
There were 20 of them, cute and innocent as could be. The farmer raised his shotgun and pumped one shot after another into each one of them, killing every last piglet, and their mothers too. This was heart-wrenching for the farmer, but he knew he had no choice since the State of Michigan was about to descend upon him with a SWAT-style team intending to arrest him as a felon if any of his pigs were found alive on his property. His crime? Harboring an animal that the State had designated as an “invasive species”. And this farmer’s tragedy was not the only one to play out in the State; there were thousands of others facing similar dilemmas.
Not too long ago, I was at the Clark’s Nutrition store in Palm Desert, CA. Well-stocked and so clean you could eat off of the floor, this store had another equally impressive side to it that caught my eye: a Value Added Information Center. Not only could you buy what you needed for your body, but you could also get what you needed to nourish your mind.
It would take at least a slim volume to provide you with all of the necessary nuances of preparing your own trademark application. An article can hardly do it justice, so if you want to protect your trademark and feel uncomfortable about doing it yourself, consult with an attorney qualified in trademark matters and have that attorney prepare and file your application. If, on the other hand, you want to protect a trademark you created through a Federal trademark registration (valid in all 50 states and territories), and feel that you could handle an online form, then, here is your brief guide.
What started out as just an idea has now become reality. When I first heard in early July that the U.S. Food and Drug Administration (FDA) had just released its Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, almost my first thought was that the watershed date of October 15, 1994, set in the Dietary Supplement Health and Education Act (DSHEA)—which defines as “new” any dietary ingredients introduced into the marketplace after that date and requires their notification to the FDA before sale—had to be changed.
Everyone with even an ounce of common sense has grave concerns about the U.S. Food and Drug Administration (FDA)’s “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” which was released last July. This Agency sprang this trap on both industry and consumers without seeking any prior input from us at all. It had almost 17 years to seek our opinion before coming out with this document, and then decided to give us a miserly 90 days to respond with our comments, which period was just extended by an additional two months. Why should we be concerned about this document?
After some 18 years and seemingly interminable debates between two sharply divided camps, the Codex Committee on Food Labelling (CCFL), at its 39th session held in Quebec City, Canada, the week of May 9–13, 2011, finally reached a consensus on a watered-down labeling guideline for genetically modified organism (GMO) foods.
Recently, I had the pleasure of flying across half the world and back so that I could attend two different, back-to-back Codex meetings at both ends of the trip. That was the fun part. The hard part was reconciling the supposedly disparate concepts embodied in these two Codex committees as they worked on standards for food additives and contaminants in food.
In late February, the U.S. Food and Drug Administration (FDA) denied a citizen’s petition filed some 18 months earlier by OVOS Natural Health Inc. to have homotaurine accepted as a new dietary ingredient (NDI) for use in dietary supplements.
Under the usual guise of protecting the public and the more-honest notion of rationalizing herbal-medicine regulations, the European Union (EU)’s Parliament and Council adopted its Traditional Herbal Medicinal Products Directive (No. 2004/24/EC), or simply the THMPD, in 2004.