FDA held a 3 hour webcast last week detailing its industry guidance on the new CGMP regulations. The webcast has been archived. To view the webcast at your leisure click here.

Best-selling author Kevin Trudeau has come under fire again for violating an injunction banning him from making infomercials that misrepresent the contents of his latest book entitled "The Weight Loss Cure ‘They’ Don’t Want You to Know About."

Harlem resident Christopher Woods (no relation to Smiling Bob, pictured at left), has filed a lawsuit against pharmaceutical manufacturer Novartis AG, claiming that its popular Boost Plus Nutritional Energy Drink caused him to have an erection that lasted several days and required corrective surgery, according to press reports.

Peter Quinter, Partner and Chair of the International Law Practice at Becker Poliakoff will moderate "FDA and You: Creating Best Practices for Importing Food and Medical Devices" on June 13th at the Miami Free Zone in Miami, Florida.

Elizabeth D. Gobeil, Partner at Thompson Hine LLP, of Atlanta, Georgia is our featured expert and provides this guest blog entry on the new FDA FAQ on Medical Foods.

Last fall, supplement industry trade group The Council for Responsible Nutrition (CRN), announced a new initiative, in partnership with the National Advertising Division (NAD) of the Council of Better Business Bureaus (CBBB), to increase monitoring of advertising for dietary supplements.

Mark A. LeDoux, Chairman and CEO of Natural Alternatives International, Inc. and Chair of The Council for Responsible Nutrition spoke next at the American Conference Institute conference on dietary supplements, nutraceuticals and functional foods on the issue of new GMP rules for dietary supplements.

Discussion at the American Conference Institute conference on dietary supplements, nutraceuticals and functional foods turned to the problem the FDA faces trying to inspect the increasing volume of imported supplement and food ingredients coming into the USA from countries like China (which is the subject of an import alert allowing FDA to detain protein products from China without physical inspection as a result of the melamine scare).

Your blogger is attending (and speaking) at the conference sponsored by American Conference Institute this week on the topic of regulation and other legal issues concerning dietary supplements, nutraceuticals and functional foods.

In an unusual marketing campaign, Berkeley Premium Nutraceuticals, the creators of "Smiling Bob" (pictured) whose erections are so satisfying he can't wipe that smile off his face, are now claiming that the source of Bob's smile, Berkeley product Enzyte, is the most stolen brand in its category.

The latest issue of the Experts Edition of Vianello Consulting's excellent newsletter series cites the decision of the federal district court for Alabama's northern district in a products liability case involving Zicam No-Drip Liquid Nasal Gel, a homeopathic cold remedy.

Make plans today to attend the In-House Counsel Forum on Manufacturing, Marketing and Distributing Dietary Supplements, Nutraceuticals & Functional Foods to be held on Tuesday, May 15, 2007 to Wednesday, May 16, 2007 in San Francisco at the San Francisco Hilton.

The President recently signed the Undertaking Spam, Spyware, And Fraud Enforcement With Enforcers beyond Borders Act of 2006. The USA SAFE WEB Act gives the Federal Trade Commission expanded authority to cooperate with foreign law enforcement officials in their investigations into wrong doing in the U.S.

In its 2007 Budget Justification Summary, the Federal Trade Commission warned that in the coming year it will continue to scrutinize dietary supplement marketing practices. The FTC highlighted health products, including dietary supplements, as a key area on which it will be keeping an eye.

Karen Robinson-Jacobs of The Dallas Morning News continues her series on the ongoing investigation by the Texas Attorney General's Office of Dallas area supplement multi-level marketer Mannatech.

Proposed Federal Trade Commission Business Opportunity rules directed at multilevel marketing companies could have a devastating impact on dietary supplement and functional food companies that rely on multilevel marketing to distribute their products. 

Berkeley Nutriceuticals, the maker of “natural male enhancement” supplement Enzyte, has agreed to settle an unfair and deceptive trade practices suit for $4.7m, with about 1/3 of that going to the lawyers.

The FDA has scheduled a public hearing on the regulation of foods being marketed as "functional foods." According to this Federal Register Notice, the purpose of the hearing is "for the agency to share its current regulatory framework and rationale regarding the safety evaluation and labeling of these foods, and to solicit information and comments from interested persons on how FDA should regulate these foods under the agency's existing legal authority."

The US Tax Court has held that when a dietary supplement manufacturer suffers "shrinkage" of inventory due to spoilage of supplements it may reduce its cost of goods sold, and its corresponding tax burden, by the value of the lost supplements.

In a joint press release, the Federal Trade Commission and the Food and Drug Administration announced a “joint diabetes initiative” to stop deceptive internet advertisements and sales of products the agencies claim are misrepresented as cures or treatments for diabetes.