The Push for Stricter Supplement Regs

Pharmacists group lobbies Congress to consider pre-market supplement approvals.

By
Joanna Cosgrove
Online Editor

When the Dietary Supplement Health and Education Act (DSHEA) was passed 14 years ago, it created special provisions for supplements that were designed to keep nutritional supplement products pure and consumers safe.

But for Bethesda, MD-based American Society of Health-System Pharmacists (ASHP), DSHEA is simply not enough. “Conversations with pharmacy customers” prompted ASHP to approve “policy actions” that include lobbying Congress for stricter dietary supplement regulations in the form of pre-market approval measures. Specifically, ASHP’s goal is for supplements to “undergo FDA approval for evidence of safety and efficacy.”

The factors initiating ASHP’s actions were primarily two-fold. Brian Meyer, ASHP’s government relations director, who was not available to be interviewed by Nutraceuticals World, told The Tan Sheet (June 30, 2008) that “ASHP members are concerned by patients’ statements about interactions between medications and supplements.” The second reason boils down to ensuring ingredient claims on labels are consistent with what’s actually in the supplement pill.

Cynthia Reilly, BS Pharm., ASHP’s director, Practice Development Division, elaborated, saying, “First, there’s the general factor that currently a number of supplements are not regulated in the same way that drug products are and there are issues of purity and safety involved in that,” she said. “But what makes it even more important is that the general public is generally unaware of that fact. There is an assumption among patients and consumers that supplements are indeed safe to use. In many cases they can be, but there are important implications particularly with how these drugs might interact with other therapies that patients are taking.”

This current effort by ASHP to push for pre-market approval is not its first. In 2006, the group submitted a statement to the House Government Reform Committee for a hearing on supplement regulation, recommending Congress consider amending DSHEA to require FDA approval of supplement products based on safety and efficacy evidence.

This initial effort was buoyed by a study published in its own journal, American Journal of Health-System Pharmacists. The study, titled “Content versus label claims in ephedra-containing dietary supplements,” (Gurley, Gardner and Hubbard, Vol. 57, May 15, 2000) employed high-performance liquid chromatography (HPLC) to measure the ephedra alkaloid content of 20 ephedra-containing supplements (prior to its FDA-enforced market departure). The assay concluded that the supplements’ label claims were “markedly” different from the actual alkaloid contents, with some inconsistencies even varying between two lots of the same products.

“Because there is not this pre-market approval, you don’t have the assurance that what is labeled on the product is necessarily what you’re getting,” said Ms. Reilly, who also asserted ASHP believed, to some degree, that this is still the case today, eight years after ASHP’s study findings were published.

This time around, the group is also lobbying for FDA-approved supplement labels that disclose excipient ingredients, as well as a label format that includes warnings denoting the “potential for interaction with medications and cautions for special populations.”

ASHP is also lobbying for tighter restrictions on supplement advertising. According to the group, ads should include interaction warnings and precautions, and should be banned for products that aren’t marketed with “evidence-based information regarding safety and efficacy.”

Needless to say, ASHP’s endeavors are not sitting well with supplement advocacy groups like the Washington, DC-based Natural Products Association (NPA), which warned that ASHP’s pre-market approval proposal would have a devastating effect on the supplement industry. “Requiring pre-market approval for dietary supplements would end this industry as we know it,” said David Seckman, NPA’s executive director and CEO. “Right now it takes eight years and nearly $1 billion for the drug approval process. Few if any dietary supplement firms would be able to invest the time and money to get their products to market under such regulations.

“And while this process is going on,” he continued, “consumers would no longer have access to these affordable, safe and effective products.”

Mr. Seckman also added that should a measure like this come to pass, it would wreak havoc on the premise of DSHEA. “DSHEA would be severely gutted or repealed for pre-market approval to happen,” he said. “DSHEA has stood the test of time and remains the American public’s best protection when it comes to accessing the nutritional products it desires to maintain and improve their health and well-being. Keep in mind that the drug approval process as it currently exists has hardly been the stellar protector of public health.”

And as for the premise that pre-market approval measures might help head off potential interactions between supplements and prescribed medications, Mr. Seckman pointed out (in The Tan Sheet) that it is ultimately the responsibility of healthcare providers to ascertain that information from their patients before new drug therapies are prescribed.

Ms. Reilly countered that ASHP’s concern is primarily focused on the consistencies associated with truth in label content. “Our major concern is about what patients are taking, not that they are taking supplements and whether or not they are communicating it,” she said. “Of course, ASHP strongly believes that it’s not just about the prescription medicines that a patient takes, we also need to know about the non-prescription medicines and supplements and herbal products patients take as well.

“Both organizations [ASHP and NPA] are very much concerned with the safety of the public,” she added. “I would just point to some of the existing studies—there are concerns with the current system to ensure product integrity and consistency. We all have the same aim in mind.”

Ms. Reilly was not able to elaborate on the specific types of measures the ASHP would like to see enacted if its pre-market approval campaign wins Congressional favor, however she said “advocacy with the FDA once they have the authority,” would be certain.

‘Time to Talk’ About CAM

According to a national consumer survey conducted by the National Center for Complementary and Alternative Medicine (NCCAM), part of the National Institutes of Health (NIH), and the American Association of Retired People (AARP), nearly two-thirds of people age 50 or older are using some form of complementary and alternative medicine (CAM), yet less than one-third of these CAM users talk about it with their providers.

In an effort to improve communication between healthcare providers and their patients, in June NCCAM launched “Time to Talk,” an educational campaign designed to encourage patients—particularly those over age 50—to openly discuss with physicians their use of practices and products not presently considered to be part of conventional medicine, such as herbal supplements, meditation, naturopathy and acupuncture. Time to Talk is aimed to help ensure safe, coordinated care among all conventional and CAM therapies to minimize the risk of interactions with a patient’s conventional treatments.

“As frequent users of CAM, people 50 and older need to understand the importance of discussing CAM use with their providers to ensure coordinated, safe care,” commented Josephine Briggs, MD, NCCAM director. “Giving your healthcare providers a full picture of what you do to manage your health helps you stay in control.”

The survey behind the initiative polled a nationally representative group of 1559 people age 50 or older who said the most common reasons they didn’t discuss their CAM therapies were:

• That the physician never asked.
• They did not know they should discuss CAM.
• There was not enough time during the office visit.

What’s more, over one-half of respondents who had talked about CAM with their physician said they (not their physician) initiated the CAM discussion.

To foster a proactive and more effective dialogue, the Time to Talk campaign offers patients a variety of tools and resources, such as wallet cards, posters and tip sheets to foster the dialogue. The materials are available on NCCAM’s website.