In recent years more and more drugs, both OTC and prescription, have been made available with nasal inhalation delivery systems. Most recently, the FDA announced approval of inhaled insulin.
In a decision on precedural issues, the Third Circuit Federal Court of Appeals has ruled on the scope of federal court review of FDA regulations imposed on dietary supplements regulated under DSHEA.
Just a few short days after several former executives of Berkeley agreed to plead guilty to federal criminal charges, the FTC has filed this complaint against the company charging it with unfair and deceptive trade practices in connection with the marketing and sale of a number of the company's nutritional supplement products.
Yours truly is featured in this month's Balancing Life and Practice column at Lexis One. While I do not profess to be a poster child for balance, it is nice to get some publicity and recognition from Lexis, a resource I use regularly.
This article reports that the Federal Trade Commission has settled misleading advertising charges with Chase Revel, the creator of advertising for Gero Vita International's dietary supplements.
While doing some research I ran across this Duke law journal article entitled REGULATING FUNCTIONAL FOODS: PRE- AND POST-MARKET STRATEGY. The article is on the web in full text, so I thought I would post it.
From the Cincinnati Business Journal comes this article that details a plea agreement with four former senior executives of Berkely Premium Nutraceuticals, Inc. on mail fraud charges.
LLRX.com, the Law Librarians' Resource Exchange, the premier legal research site on the internet, has published "Researching Laws and Information on Nutritional and Dietary Supplements On the Web," the Nutrisuplaw.com
The potential impact of rules adopted by the Codex Alimentarius commission, especially what effect these rules may have on nutritional supplement availability in the US and elsewhere, has been hotly debated.
In the last 24 hours, FDA has issued two press releases on supplement issues, one concerns another ephedra seizure, and a second warns (albeit belatedly) about brazilian diet pills.
This article in Natural Products Insider contains an excellent discussion of FDA regulations regarding food additives that are Generally Recognized As Safe or GRAS. As the article notes, with the passage of DSHEA in 1994, dietary ingredients used in nutritional supplements no longer had to qualify as GRAS, but instead were regulated under a different regulatory scheme that I have described briefly in the Research Guide appended to this blog.
Beginning January 14, 2006, supplement industry lawyer Jonathan Emord who represented the plaintiffs in the landmark case Pearson v. Shalala will host “Health Law and Politics.”
Vero Beach, Florida based supplement maker Orange Peel Enterprises, makers of the Greens+ line of supplements containing, among other herbal ingredients, chlorophyl, has sued the maker of Super Greens Plus for trademark infringement.
This article reports that two professors from the College of Business and Economics at West Virginia University, Karen Russo France, Ph.D. and Paula Fitzgerald Bone, Ph.D.,
A personal note here to my readers wishing everyone a Happy New Year! Like many people, I have resolved to lose weight this year. No great supplement news there, but there is a website called SparkPeople that is offering a free on-line diet program similar to other paid programs available on the internet.
An article entitled 'Functional Drinks: an uncertain future' co-authored by Craig Simpson and Darren Abrahams, attorneys in the Brussels office of Steptoe & Johnson LLP, is featured in the 2005/2006 Life Sciences Industry Report and is available on the internet here.
According to this article the Governor of New Jersey signed an executive order today that, among other things, "directs state health officials to come up with a plan to check nutritional supplements for steroids."
The National Nutritional Foods Association has just released a guide for nutritional and dietary supplement retailers to assist stores with 2 issues: 1) what to do when the FDA comes knocking for an inspection, and 2) how to provide nutrition information to customers within the law and FDA regulations.
While nutritional supplement patents are not unheard of, it is still somewhat unusual for nutritional supplement makers to apply for patents on their formulations. Instead, supplement makers typically rely on trade secret protection, creating proprietary blends of ingredients and keeping the formula secret.