Archive for the ‘Marketing and Advertising’ Category

The Center for Drug Evaluation and Research (CDER) has indicated that among its’ enforcement priorities, CDER will take special aim at the manufacturers of dietary supplements found to be spiked with pharmaceuticals. Echoing the sentiments of FDA Principal Deputy Commissioner Josh Sharfstein, CDER has indicated that the areas identified within the industry as having the highest number of offenses are “weight loss, sexual enhancement, and bodybuilding,” with over 200 tainted products discovered by FDA. CDER’s newly formed Division of New Drugs and Labeling Compliance urges the supplement industry to stay vigilant and hold itself accountable for the products they sell by remaining informed about the materials they buy, the suppliers they are buying from, and what is added to the products.

 CDER was recently involved in the voluntary recalls initiated by several firms that marketed “aromatase inhibitors.” The Center suggested that these ingredients posed a serious “health hazard” to consumers, an allegation refuted by the companies that marketed those products, citing a lack of adverse event reports that would support such a risk. CDER is also often consulted by Customs Enforcement and FDA Compliance Officers when evaluating dietary ingredient imports. The message to supplement firms is that dietary supplements are a priority for FDA and enforcement may come from a variety of branches.

The Federal Trade Commission’s first probiotic claims case has concluded with Nestle HealthCare Nutrition agreeing to drop claims that its children’s drink, BOOST Kid Essentials, could reduce illness-related absences from school or daycare. In the first of what is shaping up to be several investigations centered on probiotic products, FTC concentrated on whether claims about BOOST’s immunity protection were backed by results from clinical studies.

FTC feels that the studies Nestle relied on to prove their case could not adequately link reduced absences to the alleged immunity-boosting properties of their product, citing issues such as the original cause of the absences and how that was related to the outcome.
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When doing a review of your labels and advertising material, you think about Federal regulations and the risk of state Attorney Generals or district attorneys investigating your claims, but what about private attorneys?

You may believe that the only worry you could have about claims from a private attorney concern the physical injury resulting from the consumption of your product.  You may think that based on your ingredients you do not have much to worry about because the risk of someone being injured is very small.  However, there is a rise of another type of claim, one that is more dangerous and more expensive than a personal injury claim.

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In a House and Senate conference of the Wall Street Reform Bill and Consumer Protection Act, conferees ultimately decided not to include the broad rulemaking authority granted to the Federal Trade Commission (FTC) in the House version of the bill advocated by Congressman Henry Waxman (D-CA). This is a huge win for the nutritional supplement industry, as the rulemaking authority that would have been bestowed on FTC could have had a dramatic impact on industry, allowing the Agency to issue Rules under the Administrative Procedures Act that directly and significantly affect advertising. Currently FTC primarily “makes law” through enforcement of existing law. Getting this proposal removed from the final legislation was achieved through the help of overwhelming grassroots support in the form of messages from constituents to their representatives, and a combined effort of industry trade organizations including NPA and AHPA educating consumers and lobbying Capital Hill. I am proud to say that I personally spent a day on the Hill meeting with Representatives and U.S. Senators from New York and California, educating them on the issues and advocating on behalf of industry.

The Senate Special Committee on Aging has scheduled a hearing entitled, “Dietary Supplements: What Seniors Need to Know.” The hearing, scheduled for 2 pm on Wednesday, May 26, 2010, will include testimony from the General Accountability Office concerning its investigation into “marketing practices” for herbal supplements.  Although the focus may be on the potential interactions between herbal products and prescription drugs, speculation is that questions about ”New Dietary Ingredients” may also be a highlight. Go to http://aging.senate.gov/ on the day and time of the hearing to view the live webcast.

Dr. Margaret Hamburg

In a March 4th letter to Senator Chuck Grassley, the Ranking Member of the Committee on Finance, Commissioner Margaret Hamburg indicated that FDA plans to “increase the appropriate use of misdemeanor prosecutions … to hold responsible corporate officers accountable” and has developed a yet to be released criteria for determining when these criminal prosecutions will be used. This letter was in response to a report released by the Government Accountability Office (GAO) entitled: Food and Drug Administration: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal Misconduct Investigations. Read the rest of this entry »