In his presentation at the FDA public meeting on dietary supplements on November 15, 2004, Dr. George Burdock cautioned that if the Agency takes an overly conservative approach to regulating dietary supplements, the process of vetting dietary supplements for safety and efficacy could grind to a halt, lending credence to the myth that the FDA is intimidated by “big pharma.” Consumers will likely pay the greatest price, falling prey to a plethora of Internet snake oil sales pitches. Dr. Burdock stressed that the needs of the consumer, the industry, and the agency could be met if the three groups were to strike a balance, but only the FDA can devise a strategy to make the balance work. He suggested three simple steps the FDA could take in order to respond to consumer demands for a variety of safe and efficacious dietary supplements, safeguard the free speech rights of the supplement industry, and prevent an additional complication from burdening an already taxed FDA staff.
Step One: The Agency would permit the use of independent Expert Panels to determine the safety and efficacy of a supplement (a step for which there is precedent – generally recognized as safe and effective for drugs and the familiar GRAS for food ingredients). Step Two: The FDA would promote consumer awareness by disseminating the safety data and specific claims approved by the Expert Panelists to the public via the Agency website. Step Three: A period of claim use exclusivity for the notifier would reward those that have invested in research and development by maintaining confidentiality of efficacy data for a period of at least five years.
While pointing to the FDA’s other uses of independent experts, Dr. Burdock also reminded attendees of the published FDA FACT SHEET, which includes a statement that third party reviews would be permitted for dietary supplements. He urged FDA not to
“reinvent the wheel” by re-doing the work of the Expert Panel, but rather to determine if the experts were truly qualified to make such judgments and whether the claim and supporting rationale were congruent. Repeating the work of the experts doomed the FDA GRAS affirmation program, and Dr. Burdock predicts a similar fate for dietary supplements review if expert opinion would not be an acceptable option for the Agency.
After the FDA has accepted a notification, a “no objection” statement would be issued and posted to its website. If the FDA determines that a notification is insufficient, the notifier would be contacted and afforded an opportunity to modify and resubmit the dossier; all data would be kept confidential to protect a possible future submission.
Dr. Burdock noted that safety data should be made public, but protecting industry’s investment in research and development by keeping efficacy data confidential for a five year period will reward those that “play by the rules.” If efficacy data remains privileged, potential copycat “pirates” are forced to conduct their own research and development in order to make claims similar to those of their compliant competitors. Dr. Burdock projected that the industry would be rewarded by continued consumer demand for safe, efficacious supplements, which would fund future marketing, manufacturing, and distributing. Consumers would be rewarded with more competitive products.
In his closing comments, Dr. Burdock asserted that if this three step plan were adopted, the FDA would be taking decisive action to protect consumers from fraudulent, misbranded and unreliable products.