McLemore: 'There is no question that a new and improved FDA is emerging'

McLemore: 'There is no question that a new and improved FDA is emerging'


Whenever the issues of quality assurance or responsible marketing come up within the dietary supplement or natural & organic product industries, discussion of the importance of self-policing often arises. The thought is that, if companies do their part to ensure the quality and integrity of their products and are vigilant about remaining within regulatory compliance, then the government won’t need to step in via enforcement or tougher regulation.

Don McLemore and his standards team at New Hope Natural Media (Nutrition Business Journal’s parent company), understand the importance of self-regulation—and, in fact, have made it their business over the last 12 years to help the supplement and natural & organic product industries do a better job of complying with current regulation. Often this can be sensitive work, as the standards team—which is made up of McLemore, Steve Taormina and Michelle Kelly—must lay down the law with potential New Hope advertisers and exhibitors to the company’s Natural Products Expo West and other tradeshows who cross the compliance line. If a supplement company, for example, makes product claims that go against the rules set out in the Dietary Supplement Health and Education Act (DSHEA) of 1994, it’s the standards team’s job to make sure that the company does not advertise in New Hope’s publications or exhibit at any of its events until the problem has been addressed. By enforcing these standards, New Hope loses business but believes that supporting industry self-regulation is important enough to warrant the potential loss of revenue. Also, over the years, the standards department has provided a value service to the company’s clients by helping them identify and correct problems before they raise the attention of government.

In June, the U.S. Food and Drug Administration (FDA) took notice of this team’s work to promote product quality and the dissemination of responsible, accurate information by awarding McLemore, Taormina and Kelly its Civilian Honor Award—an award that, up until now, has never gone to a media company and that typically is given internally within the FDA. “This is a fantastic accomplishment by the standards team, which has worked tirelessly for years to clean up our part of the world,” said Fred Linder, president of New Hope Natural Media. “[This award] comes at a time when the FDA enforcement [of current regulation] appears to be increasing—so the timing is excellent. Most impressive is how well the team walks a fine line and makes this a win for us at New Hope, a win for the client, a win for the retailer and, ultimately, a win for consumers.”

Given the importance of regulatory compliance for the dietary supplement industry and what looks to be a recent increase in DSHEA enforcement by the FDA, NBJ sat down with McLemore to talk about the current state of adherence to federal rules by U.S. supplement companies and what revved up enforcement might mean for the industry.

Nutrition Business Journal: Congratulations on your award. Why is such recognition from the FDA important for the dietary supplement and natural & organic product industries?

Don McLemore: I hope that this achievement will foster a new era of mutual respect and transparency between our industry and FDA. Ultimately, the success of the NHNM (New Hope Natural Media) standards program represents a continued cooperation by manufacturers, distributors and brokers to support industry self-regulation.

NBJ: Could you briefly explain the work you and your standards team do at New Hope?

DM: The responsibility of the standards program is to require quality standards for all of the company’s print, in-person and online products. The standards team reviews every advertisement to be placed in a New Hope property and each piece of exhibitor material to be displayed at a New Hope tradeshow for compliance with NHNM standards and federal regulations regarding dietary supplements, food and cosmetics.

The primary intention is self-regulatory; the secondary intention is to educate our clients about FDA and FTC (Federal Trade Commission) regulations and protect them from the risks of legal or regulatory actions. Clients are contractually bound to abide by this standards policy, and New Hope Natural Media reserves the right to determine the eligibility of any company or product for inclusion in its events and publications.

NBJ: What are the FDA’s and FTC’s various roles with regard to enforcing dietary supplement regulation?

DM: FDA shares federal oversight of dietary supplements with FTC. FDA regulates the safety, manufacturing and labeling of dietary supplements, while FTC has primary responsibility for regulating the advertising of these products. The two agencies coordinate closely to ensure that their actions are consistent. Their mutual goal is consumer protection.

NBJ: What type of false or misleading supplement claims are the FDA and/or FTC most concerned with? Under what circumstances do these agencies take action?

DM: As a rule, both FDA and FTC focus their attention on “cure all” products and products that claim to cure serious diseases such as cancer, AIDS, diabetes and heart disease. The FDA considers a dietary supplement product to be an unapproved--and thus illegal—drug if it claims on its label or in its marketing material to treat, prevent or cure a specific disease or condition. The FTC requires that claims for dietary supplements be substantiated.

An analysis by FDA legal specialists Ivan Wasserman and Svetlana Walker reveals that the FDA issued more than 40 warning letters to supplement marketers in 2008. The majority of those letters were on cancer claims made on Internet Websites. Over the last year, the FTC has initiated 11 law enforcement actions challenging deceptive advertising of bogus cancer cures. FTC also takes a particular interest in weight-loss products that make deceptive, false or misleading claims.

NBJ: How likely is it that the FDA or FTC will step up enforcement of DSHEA under the Obama administration? Are you already seeing evidence of this?

DM: With the increased funding, additions and changes in staff at FDA, I think there is no question that a new and improved FDA is emerging. Dr. Margaret Hamburg, the newly appointed FDA commissioner, promised a more responsive and transparent FDA. She stated that a top priority of FDA will be to “take an aggressive approach to ensure that manufacturers fully comply with their regulatory, legal and moral obligations to ensure that the products they produce for the American people are safe and effective.”

As of June 2009, the FDA had issued more than 50 warning letters specifically for illegal H1N1 flu virus products marketed through the Internet. It also announced that its Office of Criminal Investigation could seek product seizures, injunctions against sales and criminal prosecutions of those that don’t comply.

This year there have been only a few FTC enforcement actions involving the dietary supplement industry so there is no immediate evidence of a change over previous years.

NBJ: Do you feel that deceptive claims are more prevalent in the supplement industry than in others?

DM: Not in my opinion. There is a tendency for companies in the dietary supplement industry to generalize or exaggerate the therapeutic benefits of their products without having the appropriate science to support the claims. There is also a wealth of historical or traditional information available for various ingredients and that information is often misused or overstated.

NBJ: Why is there a perception that this industry is riddled by false and deceptive claims?

DM: The industry inherited a “snake-oil peddling” reputation. This negative perception is reinforced by the ongoing drumbeat by the mainstream press that dietary supplements are unregulated. Sports figures blame dietary supplements for testing positive for some illegal substance. Recent reports of many adverse events due to the use of supplements have created concerns. Probably the most prevalent challenge for the supplement industry is the availability of the Internet to immediately market products with false and deceptive claims.

NBJ: Certainly the mainstream media cry that supplements are dangerous and unregulated seems to have grown louder since the Hydroxycut recall in May. What do you think will result from this onslaught of negative press? Do you think consumers will begin to question the safety and efficacy of supplements in general?

DM: I am not sure that we can predict whether the Hydroxycut recall will have a diminishing effect on consumer confidence for dietary supplements in general. It is interesting to note, however, that a 2008 survey conducted by Public Affairs for the Council for Responsible Nutrition (CRN) reported that 81% of American adults indicated that they were confident in the safety, quality and effectiveness of dietary supplements. As you mentioned, the onslaught of negative press against dietary supplements continues to be relentless this year, so it will be interesting to see what the 2009 survey reveals.

NBJ: What are the most common illegal claims you see in your work at New Hope? Does this differ from common illegal claims made on the Internet?

DM: You name it, we see it. Claims for preventing and treating cancer, heart disease, symptoms of heart disease, high cholesterol, high blood pressure diabetes, arthritis, and colds and flu are most common for exhibitors at trade shows. Internet claims are often more misleading, egregious, blatant and extreme, and cover every malaise you can imagine.

NBJ: Do you find that direct sellers (MLMs/e-commerce/DRTV and DR radio companies) are more likely to use false or deceptive claims than a company who is selling in retail? Why or why not?

DM: Yes. For direct to consumer products to get the immediate attention of buyers, aggressive egregious, false and deceptive claims are very often used. E-commerce is the new Wild, Wild West because it’s relatively cheap and quick to post and disseminate information. An indication of this is the number of companies warned by FDA about claims on their Websites.

Because MLM campaigns are often wide spread and national, their print and media promotions tend to be scrutinized more closely by FDA and FTC. Of course there are many exceptions, and what is said in person-to-person interactions cannot be monitored.

NBJ: Is it also easier for the FDA and FTC to monitor and crack down claims made via the Internet than it is claims made via a product label or other marketing materials?

DM: Yes, forthe same reasons previously mentioned. The Internet allows for companies to immediately market products with false and deceptive claims, but it also allows for an immediate scrutiny by regulators albeit a formidable task.

NBJ: Is there a pattern that seems to be common in violating companies?

DM: As previously mentioned, I think marketers have made egregious claims because they have been able to get away with it due to a lack of enforcement by an understaffed FDA and FTC. In addition, many simply do not fully understand the regulatory guidelines for making compliant claims.

NBJ: What would you tell a company that has made false or misleading claims but that has not been punished and does not feel the need to modify its existing claims? How dangerous are these companies to the industry? Could their actions trigger new regulation or stricter enforcement of current regulation?

DM: I would explain that our policy is to work with exhibitors to help bring them into compliance. I would point out the allowable claims that are permissible under DSHEA and the federal regulations that applied to the company’s claims. Finally, I would state that he NHNM contracts include a clause stating that failure to comply with the Standards program is cause for rejection of company from advertising or exhibiting.

Companies that do not play by the rule comprise the integrity of the entire supplement and nutrition industry but it is doubtful that their actions would trigger new regulation. There is adequate regulation over the marketing of dietary supplements; it is the lack of enforcement that is missing.

NBJ subscribers can read more about supplement regulation in our 2009 U.S. Nutrition Industry Overview issue, which publishes this month. To order a copy of the issue, subscribe to NBJ or download a free 32-page sample issue, go to www.nutritionbusinessjournal.com.

Related NBJ articles:
FDA to General Mills: Cholesterol Claims Render Cheerios a Drug
FDA Increases Enforcement Efforts, Warns Internet Marketers About Swine Flu Claims
Direct Sales: A Breeding Ground for Bad Claims?


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