201502.18
Off
0

Claim Substantiation Post-POM

Do you now always need at least two randomized and well-controlled human clinical trials (RCTs) to substantiate your claims? We may have an answer from the U.S. Court of Appeals for the D.C. Circuit, which in January 2015 issued its highly anticipated opinion in POM Wonderful, LLC v. F.T.C. First, the bad news, at least…

201401.10
Off
0

The Federal Trade Commission’s New Year’s Resolution: Take Down Deceptive Weight-Loss Supplements

in FDA, FTC

Just days into 2014, the Federal Trade Commission (“FTC”) made headlines by announcing enforcement actions against four weight-loss companies.  As a result of this so-called “Operation Failed Resolution,” the companies—HCG Diet Direct, Sensa Products, L’Occitane, and LeanSpa—must pay a collective total of $34 million to refund consumers who may have been misled by their ads. …

201311.11
Off
0

Dietary Supplements and Intellectual Property: How Can You Protect Your Brand?

After spending countless hours building a business from the ground up—formulating a line of supplements, securing supplies, manufacturing and marketing products, and finally selling them—a supplement company wants nothing else but to succeed.  But what can one do to stop others from using the company’s name to capitalize on its success?  How can an owner…

201311.06
Off
0

How Do YOU Handle Adverse Event Reports?

Suppose that somebody calls your dietary supplement company to report that he experienced shortness of breath and heart palpitations shortly after taking one of your products.  He is en route to the hospital, and he believes that your product is to blame.  Who at your business takes this call?  How does he or she respond? …

201310.21
Off
0

The Attack on Industry Continues as Newsday Proclaims “Problems Persist in Supplement Industry”

This weekend’s Newsday featured an article lamenting the perceived under-regulation of dietary supplement companies.  Citing contaminated products and discussing the “poisons” in supplements, the article is sure to alarm consumers.  However, the reality is that dietary supplements are heavily regulated, and the vast majority of supplements are no more harmful than any other food. The statement…

201309.26
Off
0

FDA Cracks Down as Industry Continues to Struggle with Ingredient Specifications

Under the 2007 supplement Good Manufacturing Practices (“GMP”) final rule, as well as the pending Food Safety Modernization Act regulations, supplement companies must set out specifications to identify an ingredient’s source and lifecycle.  Industry has struggled to comply with the GMPs in this area.  Since April 15, 2013, FDA has issued at least six Warning Letters…

201308.01
Off
0

Sen. Durbin Likely to Reintroduce the Dietary Supplement Labeling Act

Dietary supplement regulations have been a hot topic on Capitol Hill lately.  Earlier this week, Sen. Dick Durbin, D-Ill., announced that he will reintroduce the Dietary Supplement Labeling Act along with Sen. Richard Blumenthal, D-Conn. According to the Natural Products Association, “Sen. Durbin explained that this legislation will require more information on dietary supplement labels….