Getting substantiation right for claims especially important in healthy aging, expert says

15-Oct-2018 - Last updated on 15-Oct-2018 at 16:38 GMT

Making claims on products in the healthy aging sector is fraught with peril, as older adults, along with children, are seen as the most vulnerable populations, an expert says.

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Katie Bond, an attorney in the firm Amin Talati Upadhye, advises clients on how to stay on the right side of regulations when making claims. This is always important, she said, but especially so in the area of healthy aging. Regulators both in the Food and Drug Administration and the Federal Trade Commission have taken the stance that elderly consumers are a subset of the population that need special protection.

Cognitive support products of special concern

And it’s not just the Executive Branch that is concerned about this. Several years ago, Sen. Claire McCaskill, D-MO, launched inquiry into brain health supplements for seniors. Many elderly consumers feel threatened by Alzheimer’s disease and other degenerative neurological conditions and the drug treatments for these are far from satisfactory. In this atmosphere, Sen. Sen. McCaskill said that some supplement purveyors were taking unfair advantage. She sent letters to 15 major retailers and the Food and Drug Administration asking about policies relating to the sale of fraudulently marketed dietary supplements.

“People looking online for cures or treatment for Alzheimer’s Disease and dementia are at their most desperate—and it’s clear from what we’ve found that many of these products prey on that desperation,” Sen. McCaskill said.

After the election of Pres. Trump and the ascendency of Republicans to the chairmanships of Senate committees, Sen. McCaskill has gone silent on the issue. (She also has a hard reelection fight to occupy her time.) But it’s a signal of the feeling among many legislators that the marketers of dietary supplements can’t necessarily be trusted when it comes to the messages they convey to perhaps slightly befuddled older consumers.

“There is a lot more risk when you are talking about an older population,” Bond told NutraIngredients-USA. “The FTC believes they are more vulnerable. There is certainly a bigger risk of coming onto the radar with FTC when making claims in this area.”

Matching substantiation to the claim

Bond said the rule of thumb of making claims match as exactly as possible the underlying substantiation is a basic tenet in this category as it is with others. But recent rulings have provided some additional detail for making claims in areas such as memory support.

In 2014 DSM came to an agreement with FTC over memory claim sit was making on its algal DHA product. In that settlement, FTC laid out specific areas of memory, such as episodic or spatial memory, that substantiation must specifically address. Even though DSM had a large scale study to back its ingredient (485 subjects), FTC concluded that the claims went a step too far.

“I think FDA has made it clear that if you are just making generic claims about memory loss in connection with aging, that is not going to construed as a disease claim,” Bond said.

“The DSM-FTC case was an interesting one because it was a split decision, with some dissenters who thought the company did have substantiation. One wonders whether under the current political makeup of the commission that case would have come up the same way,” she said.

Don’t mix pain with joint health

Another area in which disease claims get jumbled up with allowable structure function claims in the area of joint health. After maintaining cognitive function, maintaining mobility and thus the ability to continue to live independently is No. 2 on most elderly consumers’ lists.

Complaints in this area focus on stiffness and reduction in range of motion. But they also center on the pain caused by rheumatoid and osteoarthritis, which is where companies could get into trouble, Bond said.

“Where FDA has come down on that centers on express or implied claims about treating rheumatoid arthritis or osteoarthritis. When you are mixing joint claims [about joint comfort, resilience or flexibility] with pain claims, that’s when you would be crossing the line into implied claims for arthritis,” she said.

“There has been a lot of class action in this area. Glucosamine and chondroitin in particular have been targeted," she said.

Line is blurry in strength maintenance

In the case of memory claims and joint claims, specific disease conditions underlie these categories; Alzheimer’s and other forms of dementia in one case, arthritis in the other. In a third major area of Healthy Aging—the maintenance of strength and muscle mass—the underlying condition—sarcopenia—is less researched and less well defined.

There has been far less regulatory activity in this sector than in the other two. Still, Bond said that even when the disease claim line in the sand is blurry, companies ought to err on the side of caution by having specific substantiation in hand. A generic ‘protein has been shown to help preserve muscle mass’ might not cut it when marketing a sarcopenia product at an elderly demographic.

“The National Advertising Division has looked at least one case in this area, and in that case they found that the marketer was able to substantiate their claim. I think it’s unlikely, though, that regulators would rely on the general substantiation that’s out there. You would need some specific hook,” she said.

“An example could be drawn from energy drinks that were targeted at female fitness enthusiasts. The NAD expected in that case to see a lower dose of caffeine to match the lower body weights,” she said.

Katie Bond is a panelist for our live Q&A session at our upcoming Healthy Aging online conference

Join us for our FREE online conference on Thursday, Oct. 25.

Healthy aging is a hot product development category, as companies try to help consumers realize the goal of making 60 the new 40. NutraIngredients-USA’s online event will feature a market overview by category expert Diane Ray of the Natural Marketing Institute. It will also feature sessions by top suppliers.

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To close the event, a blockbuster panel of legal, scientific and product development experts will consider the burning questions and future directions of this increasingly vital industry sector. We will look at formulation questions, market dynamics, claims issues and more.