Legal advice to avoid FDA/FTC claim clamp- down

Previous articles in the series have focused on the different types of health claims that the US Food and Drug Administration (FDA) allows for use on foods and dietary supplements, as well as the enforcement strategies adopted by FDA and the Federal Trade Commission (FTC).

Ivan Wasserman, a partner at Manatt Phelps & Phillips in Washington, DC, has identified ten major points to help steer manufacturers to the bucks and not to the courts.

Just because others do it, doesn't mean it's

OK

FDA regulates product labels, whereas FTC regulates product marketing.

However, both agencies have limited resources, which ultimately means that they cannot stay on top of every new product launch.

Nevertheless - budgets allowing - the agencies will clamp down when misleading health claim use is brought to their attention.

When this happens, companies are held responsible for their marketing, regardless of competitor activity.

"Just like you can't get out of a speeding ticket for going 59 mph by arguing everyone else was doing 80, ' everyone else is doing it' NEVER works at the FDA or FTC," said Wasserman.

Just because it's natural doesn't mean it's safe "Hemlock, poison ivy, and lead are all 'natural'," said Wasserman.

FDA and FTC both use science as a golden standard, and this is what any safety claims for a product or ingredient need to be based on.

"Simply the fact that it's natural, or that you don't know about any safety concerns, is not enough to make an affirmative claim that your product or ingredient is safe."

Beware of fairy dust If a manufacturer highlights the fact that a product contains a particular ingredient, this is considered to be an implied claim that the ingredient will have some effect.

Some companies may add small levels of the 'ingredient of the day' - or 'fairy dust' - to their products and then flag up its presence, said Wasserman.

"Make sure the ingredient is in there in significant levels to be effective."

Keep apprised of FDA/FTC enforcement actions "Especially in some of the grayer areas, knowing the opinions expressed by the agencies in the context of enforcement actions will give you valuable information that you can use when deciding whether to launch a new product or tweak an existing one."

The agencies both detail their enforcement actions and the types of claims and products they are targeting on their websites or through reporting services.

Companies can also keep up to date through working with regulatory lawyers or consultants.

Stay away from miracle cancer cure patches for overweight children FDA and FTC have both stressed that they are particularly wary of 'miracle cures' or 'all-in-one' cures.

High on the agencies' radars are claims to cure serious diseases, products targeting children, and weight loss.

They also look out for 'patches', as dietary supplements cannot be topical - they must be ingested.

DBPCSS Double Blind Placebo Controlled studies with Statistically Significant Results are key to substantiating claims, said Wasserman.

"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, including weight, memory, sexual performance, etc. you will want to have this for support, and anything less will leave you vulnerable."

"If there was no placebo control, it is hard to say that the result was not due to placebo effect, and if the results were not statistically significant, it is hard to say that they were not due to chance."

If you've got it flaunt it However, despite the need for caution, companies should not be scared to make claims that can be substantiated.

"If you have a compliant claim with the right substantiation, by all means make it.

Even if it is weight loss!" said Wasserman.

"Make sure that you have checked all the boxes, for example, the study is DBPCSS, the product is what was studied (same product/dosage), the claim matches the study (combined with diet exercise, specific subject population (women, elderly), and then go for it."

Beware of dog Animal studies can be important for support, but they cannot stand alone as sufficient evidence to support the efficacy of a product.

Human clinical studies are what hold the real weight, and any support from animal studies is an added benefit.

Keep your customers happy "If your claims don't have the right support, your product won't have the right effect, and your customers won't be happy," said Wasserman.

Customer complaints can also serve to alert regulatory agencies to the need for action.

In addition, companies should be sure to keep their promises, said Wasserman.

For example, if products make money back guarantees, then companies should be prepared to honor the promise.

Show me the money!

When companies do not have the internal expertise to stay abreast of regulatory requirements, they need to look to take on a regulatory consultant or lawyer, said Wasserman.

"Getting the advice of a qualified lawyer or consultant before launching a product or an advertising campaign may not be cheap, but it can be money well spent, and end up saving you a lot in the long run."

The earlier a company gets this advice the better, as it could prevent wasted dollars on inappropriate product development and promotion.

Ivan Wasserman, who specializes on advertising and labeling issues in the food and dietary supplement sectors, was addressing industry members last month at a regulatory compliance presentation at Expo West in Anaheim, California.

Other articles in the series: Choosing Health Claims FDA enforcement action on health claims FTC's two-pronged approach to ensuring accurate marketing When FTC gets tough on misleading marketing