Author Archive
Substantiation of Claims is No Longer Simple or Cheap
Two recent settlements with the FTC in addition to a NAD review of another
company’s advertisement shows that no longer can one rely on inexpensive in vitro, animal tests. Further third party clinical trials or small pilot studies on one’s own products are also risky unless they are rigorous and directly related to the ingredients and the amounts of those ingredients in the product. Recently the FTC entered into consent agreements with Iovate and Nestle products. Those orders required the products in question to have 2 double blind placebo controlled studies for the products. While the FTC stated that these standards only applied to the particular claims and products in the settlement and that the definition of “reliable scientific evidence” is “flexible”, using some old animal or in vitro studies to support your claims will no longer be sufficient. The NAD or National Advertising Division of the Better Business Bureau said this specifically as it pertained to MuscleMeds advertising for its Armatest product. Bottom line, you need rigorous scientific support for your claims. We recommend retaining third party scientific experts to help you conduct that search and analyze your claims and to do so before you being marketing your product and before the regulators come knocking on your door.
Safeguarding Against Class Action Lawsuits: Knowing Your Manufacturer
Marketers of sports supplements must not only be careful as to who is manufacturing their products, but where they, or their manufacturers, are getting their raw materials. As part of the GMP practices, distributors must also make sure their raw materials are in compliance.
This obligation can be complicated by overseas suppliers where there may be less regulatory oversight. However, a recent development in India shows that this might be changing.
A regional government in India has suspended the license of an herbal drug manufacturing company for allegedly mixing steroids and other pharmaceutical products. In addition, the owner of the company and a distributor were charged criminally.
Why is this important? While it is good business to try and find your ingredients for the cheapest price possible, one cannot sacrifice quality for price if it will end up being more expensive in the long run. Such a decision could ultimately result in a product recall or costly class action litigation.
Though overseas governments may take action when their laws and policies are violated, one should not and cannot rely on that enforcement. Know your supplier. Have your raw materials tested and validated. It will save a lot in the long run.
Read the full story at: http://www.expressindia.com/latest-news/punjab-suspends-pharma-firms-licence-for-mixing-steroids-in-herbal-drugs/644068/
The Class Action Jackpot
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.
