New Hope Standards Group takes high road on health claims

New Hope Standards Group takes high road on health claims

New Hope Natural Media is the only media company in the dietary supplements and natural foods industry with a department devoted entirely to health claims compliance. That’s the boilerplate; but what does it mean?

The New Hope Standards Department has been one of the best-kept secrets of this company. It forms the regulation-compliant framework under which all of New Hope Natural Media's business is conducted, whether at trades shows or other events or in New Hope's various publications.

New Hope is the only media company within the natural products industry that has a dedicated Exhibitor and Standards Department. That's the boilerplate. But what does it mean?

It means that everything that appears on the floor at SupplyExpo, Natural Products Expo West and the other New Hope trade shows – all of the banners, all of the handout literature – goes through a rigorous process to ensure that it complies with federal regulations. It means that the advertisements that appear in New Hope publications go through the same process. It means that New Hope's industry partners are willing to step up to the plate in cooperation with Don McLemore, director of the New Hope Standards Department, and his team members Michelle Kelly Zerbib and Steve Taormina, to try to make this a better, more reliable business.

It's an effort that has drawn kudos from industry.

"I think it has no equal in the industry,"said Scott Steinford, president of ZMC-USA and also an industry consultant. "The biggest obstacle we have as an industry is overcoming bad players, and I think the New Hope Standards Department has gone a long way to make sure that doesn't occur.

"The standards department levels out the playing field for those companies that are dedicated to doing the right thing. It provides a greater degree of confidence from a marketing standpoint. We know that there are not going to be issues that arise over companies making unsubstantiated or unfair claims.”

It's a critical differentiator for New Hope, said Loren Israelsen, executive director of the United Natural Products Alliance.

Birthed by DSHEA

To understand why this became a priority at New Hope, we have to delve into history. During the tumultuous birth of the Dietary Supplements Health and Education Act (DSHEA), which became law in 1994, questions were raised in Congress about industry responsibility in the relatively free market that DSHEA would bring about.

"A number of key members of Congress – the Kennedys and the Waxmans of the world – quite rightly said, ‘Why do you deserve it and what kind of standards and practices do you have in place that would reassure us that if we do agree to this, that this won't all go badly?'" Israelsen said.

That led to an urgent scramble to catalogue the standards and practices then extant in the industry in 1992-93, forming the Natural Products Quality Assurance Alliance (NPQAA). That group produced something of an encyclopedia cataloguing definitions, industry practices, etc., that was presented to these key members of Congress as part of a demonstration of the earnestness of the natural products industry.

In the midst of this ferment, New Hope sponsored a meeting in the fall of 1992 at the Hotel Boulderado, in New Hope's backyard, according to Israelsen, who was there.

"It was on neutral ground, which was getting hard to find," he said.

The meeting focused on what Israelsen called the "first principles"of DSHEA, which he summed up as: How does the industry provide broad consumer access in an atmosphere of confidence and trust in the products being offered? They must go together.

"New Hope has consistently been a champion of the first principles of DSHEA, but also a champion of the second, underlying principle: the responsibility not to screw this up. New Hope did what it could do as a trade show provider and as a publisher. They set the standards in place and then they just did it," Israelsen said.

McLemore was working at the time for the Herb Research Foundation, a nonprofit organization.

New Hope contracted with the foundation to put together a standards program, and McLemore was the obvious choice as the first, and to date only, director of the department.

"I came (to the natural products industry) after a career in the medical industry. I wanted to find a way of life and a profession that was consistent with my philosophy," McLemore said. McLemore and his team collect the material for all the trade show booths and review it for compliance with claims language allowed under DSHEA. They also vet all of the advertisements that appear in the various New Hope publications.

How Standards work

What they find is sometimes surprising, McLemore said. "Some of them [natural products companies] don't know there is a DSHEA," McLemore said. Regardless, whether it's a long-time client whose ads and booth materials are generally compliant or a first-time exhibitor whose approach is a little, shall we say, edgier, the same standards are applied to all.

"We don't just run people off. We try to work with people. It is an education process," McLemore said.

"It is unfortunate how many companies appear to be not aware of the rules or unwilling to comply," said Israelsen. "I attribute that to the extended summertime the industry has enjoyed for 16 years in the post-DSHEA era when it has been blue skies and 72 degrees for most people most of the time."Many companies and decision makers came into the industry in the post-DSHEA period of rapid growth.

"And they really don't understand how difficult it was – that FDA was very aggressive. Times were pretty dark. Companies didn't know what they could tell their customers. You didn't know what ingredients FDA would go after," he said.

Some companies have problems because of almost willful cases of ignorance. McLemore cited the case of a major company based in Europe that wanted to exhibit its products at Expo West. The labeling for the products and the associated information was completely noncompliant.

"You'd think if you were spending that much money you'd want to hire a regulatory consultant," McLemore said. Nevertheless, it went through the process, using McLemore and his department as, in effect, free consultants. In the end, the manufacturer decided that it would not be able to meet the regulatory requirements.

Some companies cut even more corners, trying stunts that border on being illegal. Taormina showed a case of a falsified organic claim, in which a company replaced the certified name with its own. It's not an isolated incident, unfortunately.

That segues into a key point of the standards department ­– the complete autonomy McLemore and his teammates have in applying the standards and making decisions on those companies that don't measure up.

"[New Hope executives] said to me, ‘When it comes to standards, it's your call. We know we will lose some exhibitors and advertisers,'" he said.

The standards department turns away about 10-20 potential exhibitors every Expo West. "Some of the booths we turn away… you would not want to exhibit next to them if you were an exhibitor," McLemore said. 

Fewer print advertisements are turned away. Zerbib handles most of the work associated with bringing print ads into compliance. "I have a pretty good record," she said.

The combination of lost revenue and the significant investment of having three full-time employees devoted to this work is the price New Hope pays to be able to say that it is supporting and fostering best practices within the industry. And to be able to say with backing from industry that New Hope puts on the most carefully vetted events in the natural products industry.

"It's raised my opinion of New Hope above others to know that those kind of standards are there," Steinford said.

"At the end of the day, as companies believe that if you go to a show that is vetted, as the standards rise and there are greater expectations and insistence that we can do better, my hope is that exhibitors at Expo West and SupplyExpo will use the fact that they are there on the show floor as a badge of honor," Israelsen said.

Review process: Nuts and bolts

• When exhibitor or advertising claims are noncompliant, clients are notified that the claims must be omitted or revised in order to exhibit or advertise.

• In the case of unacceptable drug claims, the department provides the client with examples of acceptable structure/function claims (with a disclaimer that advice does not constitute a legal review for compliance with FDA/FTC regulations).

• Clients are given a comprehensive list of FDA/FTC regulatory and scientific consultants.

• Clients are also supplied with FDA/FTC warning letters to other companies that have made similar claims.

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