10 New Year’s Resolutions for 2011

Ivan Wasserman, a partner at Manatt Phelps & Phillips in Washington, DC, who specializes in the regulation of the marketing of such products, has identified ten New Year’s Resolutions to help keep your company from drawing regulators’ ire in 2011.

Resolution #1: I will not rely on “safety in numbers” ​​

Just like you can't get out of a speeding ticket for going 56 mph by arguing everyone else was going 80, the argument that 'everyone else is doing it' NEVER works at the FTC (or the FDA). There are a LOT of products and claims out there, and the regulators’ 'speed traps' cannot catch everyone.

Resolution #2: I will beware of “pixie dust”​​

As illustrated by the FTC’s recent settlement with NatureSmart LLC, if you highlight the fact that a product contains a particular ingredient, a regulator can consider it to be a claim that the ingredient is in the product at a significant level and, of course, has the claimed effect. Therefore, be sure that it is in the product at the amount needed to be effective.

Resolution #3: I will keep apprised of FTC/FDA enforcement actions and public comments​

Especially in some of the 'gray-er' areas, knowing the opinions expressed by the agencies in the context of enforcement actions and in public comments will give you valuable information that you can use when deciding whether to launch a new product or tweak an existing one.

Resolution #4: I will stay away from miracle cancer cures for overweight children ​
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As in the past, high on the agencies' radars in 2011 are likely to be products that claim to treat serious diseases, products targeting children, and 'miracle' weight loss and similar products.

Resolution #5: I will have DBPCSS ​
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Double Blind Placebo Controlled studies with Statistically Significant results are key to substantiating claims for dietary supplements and functional foods. While it is not a hard and fast rule, and there are certainly exceptions, if you find yourself in a position that you need to defend a claim that your product has an effect on health, anything less may leave you vulnerable.

Resolution #6: I will make sure my claims match my substantiation​

Even with DBPCSS, you need to be sure that the claims match the study! Check the boxes: same product; same dosage; same target population; etc. And be careful not to overstate the results!

Resolution # 7: I will avoid claims that require FDA approval (unless I have it!) ​

As evidenced by the FTC’s settlements in cases like Iovate and Nestle, claims that require FDA approval and do not have it, i.e.​ claims that a product can treat, cure or prevent a disease, remain high on the FTC’s enforcement radar (and may violate FDA rules!). If challenged, it is likely to be very difficult to substantiate the claim to the FTC’s satisfaction.

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Resolution #8: I will keep my customers happy​
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Perhaps most important, if your claims do not have the right support, your product may not have the right effect, and your customers will not be happy.

Resolution #9: I will be wary of being penny wise and pound foolish​

The earlier a company involves qualified experts the better, as it can help prevent wasted dollars on inappropriate product development or promotion.

Resolution #10: I will have a successful 2011!​

To end on a positive note, despite the need for caution, do not be scared to make great claims for great products. If you have a compliant claim with the right substantiation, by all means make it, and have a great 2011!