In an upbeat joint address at the Council for Responsible Nutrition's thirtieth annual conference last week, chairman Byron Johnson and president Annette Dickinson stressed the value of science for health claims, the need to work together to inform health practitioners of the benefits of supplements and a new-found support for FDA's regulatory requirements.
Johnson opened the address in the negative tone of today's industry saying that "all around us our industry is dealing with negative publicity, disappointing science and the threat of restrictive legislation." However he quickly sought to give industry hope for the future, stating that with new leadership CRN is now "reinvigorated, revitalized, and demonstrating a renewed dedication to leading the industry to new and higher ground".
Main emphasis in the address was placed on the need for companies to combine innovation and profitability with legitimate research on safety and benefit.
"Many consumers wonder what supplements they can really trust. Until responsible companies find a way to distinguish themselves from the hangers-on, that question will persist," said Dickinson.
Moving onto the issue of product stewardship, Dickinson said the matter would require ongoing development and constant tending. She also encouraged all CRN members to get involved in this program now, while it is still in the developmental phase.
CRN staff and the regulatory and quality assurance specialists at its member companies have spent the past five months immersed in the new Good Manufacturing Practices (GMPs). According to Dickinson, during this time, close to 30 member companies have assisted in CRN's efforts to analyze and respond to FDA's 'disappointing' proposed rule. As a result the CRN has now submitted a total of almost 300 pages of comments to the agency, but Dickinson insisted that the council's work on this critical issue was only just beginning.
"Now that the comments are in, our real challenge is to be sure all our work results in actual change to benefit the industry. This regulation is critical to the future of our industry and we will partner with FDA to help them get it right," said Johnson.
Despite its unrelenting campaign to modify the GMP proposal, the CRN address revealed the increasing willingness to support FDA and its members involved in dietary supplement regulation. The speakers referred to FDA's new organizational structure within the Center for Food Safety and Applied Nutrition (CFSAN) and the addition of a number of new personnel. The Office of Nutritional Products Labeling and Dietary Supplements (ONPLDS) - headed by Dr Christine Taylor - also has a new division for dietary supplements, under Dr Susan Walker who has assembled a team of people who, according to Johnson, bring a new level of expertise to CFSAN.
The best thing that could happen to the industry would be for FDA to assign Dr Walker the task of bringing in some experts in quality assurance theory and practice to move this proposed rule to the next stage, said Johnson.
He added that for the first time since DSHEA was passed in 1994, FDA now has a Commissioner who is committed to enforcing the law instead of fighting it. "FDA finally appears to be willing to accept the authority and enforcement control they have over our industry under DSHEA, and we must make sure that they are not derailed from that mission."
Issues which could not be avoided in the speech included ephedra, andro, and adverse event reporting, which the CRN says have all been preventing the industry from highlighting the safety and benefit of the vast majority of dietary supplement products. The speakers confirmed, however, the CRN's faith in the FDA's ability to deal with each of these issues in the near future.
On ephedra, CRN is prepared to support FDA Commissioner Mark McClellan, provided his actions are based on good science and reasonable regulatory policy. "Nothing would send a stronger message that DSHEA works when it is properly implemented," the industry representatives commented.
In the case of andro they said the CRN would support an approach that lists it under the Controlled Substances Act.
The issue of Adverse Event Reporting is rather more complicated however. Risking the displeasure of some in the industry, the speakers announced that within the past month, the CRN Board of Directors had decided to support the mandatory reporting to FDA of serious adverse events relating to dietary supplements.
Johnson explained that through each of these efforts, the CRN would almost certainly eliminate the call for broad sweeping legislation. Adding that by dealing effectively with these challenges the industry would be able to turn its attention to strengthening consumer confidence in its products.
The main route, however, to consumer confidence in the industry's products is through science, according to Dickinson, who called for more investment in research to show both safety and benefit. Another important factor is the building of alliances with other groups that can help CRN educate people about the safety and benefits of dietary supplements.
Last, but not least Johnson emphasised the importance of working with government agencies such as the FTC and the FDA to fight against misleading claims, whether in labeling or in advertising, because false claims give the whole industry a bad name.