October marks the tenth anniversary of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This controversial law has been vilified by its critics in conventional medicine, in the media, and in Congress for some of its alleged weaknesses.

Quality is an issue that has received much media exposure. In DSHEA, Congress authorized FDA to issue good manufacturing practices (GMPs) that are more stringent than those already existing for dietary supplements, i.e., those GMPs that all food manufacturers must meet. After years of industry groups attempting to work with FDA to produce new GMPs that are modeled on food GMPs (as stipulated in DSHEA), FDA will reportedly issue its final GMPs for dietary supplements some time before the end of this year. (See HerbalGram articles on the proposed GMPs in issues 58 and 59.) This issue contains articles dealing with numerous GMP-related topics: botanical voucher specimens for ensuring proper herb identity, high quality reference standards (pure compounds) for use in chemical analyses, the National Institutes for Standards and Technology’s program for certifying analytical reference materials, and in vitro bioassays for assessing activity and bioavailability of herbal preparations.

One of the provisions of DSHEA about which most journalists and healthcare professionals with whom I speak appear to be totally ignorant is the provision on “new dietary ingredients” (NDIs). DSHEA requires that any ingredient not sold in the U.S. before October 14, 1994, be classified as an NDI. This contrasts with a dietary ingredient previously sold in U.S. commerce, the relative safety of which is presumed, unless there is evidence to the contrary. For NDIs a seller must submit safety data to FDA at least 75 days prior to the introduction of the ingredient. The FDA has authority to accept the data, which allows the ingredient to enter the market, request more data from the seller, or reject the submission. FDA can reject the submission if it concludes that either the data show the ingredient is unsafe or, as often appears to be the case, there are insufficient data in the submission.

Chris and Patrick Noonan’s article discusses the need for manufacturers to make NDI submissions and the level of evidence required to lawfully determine the safety of an NDI. Of 113 NDI submissions for botanical ingredients since passage of DSHEA through June 2003, 70 percent of them were rejected by FDA. This should give some critics of DSHEA some pause before they dismiss the Act for not having safety protections. But the reasons for the relatively high rejection rate may be less transparent. FDA has not published a guidance document on NDIs that shows the level of information needed to meet the Agency’s criteria for acceptance. This lack of clarity is at the root of the reason for many of the rejections. The authors suggest that some of the rejected NDIs might have been accepted if the submitter had more guidance on how much additional safety documentation should have been included.

The flipside of the NDI issue is the assessment of the safety of those dietary supplement ingredients that are currently on the market. With some highly exaggerated concerns about herb safety since the ban on ephedra, there’s growing traction in all quarters on creating a mandatory reporting system for serious Adverse Event Reports (AERs), with some probable legislation coming from Congress this year.

The AER debate has taken center stage since ephedra went down. Senators Dick Durbin (D-IL), a vocal dietary supplements critic, and Orrin Hatch (R-UT), a co-author of DSHEA and a strong supporter of the dietary supplements industry, have agreed to cooperate on legislation this year that includes a provision for a mandatory reporting system by manufacturers for serious AERs associated with the use of dietary supplements. Of course, the devil will be in the details.

In 2003, the American Herbal Products Association (AHPA) proposed mandatory reporting for serious AERs. Other dietary supplements industry trade groups have also supported such initiatives, at least in principle. In February, ABC cosponsored a conference for industry on AERs with the Utah Natural Product Alliance (UNPA). In June, ABC and some trade groups (AHPA, CHPA, and CRN) supported another AER conference sponsored by UNPA and the new Center for Dietary Supplement Safety at the University of Minnesota. The June conference indicated that everyone was willing to work out the language for an effective AER system for dietary supplements.

The existing AER system at the FDA is inadequate to assess the safety of an ingredient, and national poisoning databases, such as the Toxic Exposure Surveillance System (TESS) of the American Association of Poison Control Centers (AAPCC), are not designed to help establish a safety track record for products such as dietary supplements. Neither the current FDA nor the AAPCC systems should be used to provide the basis for regulatory policy. At best, they can help identify events that signal a potential problem or issue, e.g., identifying sentinel events. (See the article Rick Kingston and I wrote in HerbalGram 60 on the inadequacies of the AAPCC/ TESS database.)

An industry-supported reporting system for serious AERs should be prospective, i.e., designed in a way that adequately and properly records relevant information so it can be used retrospectively in a meaningful way. This can be accomplished by using a competent third-party system embraced by a wide segment of the dietary supplements industry that is designed to receive, evaluate, and report the AER experiences in proper context. With the probability of a congressional mandate coming soon, a properly designed system for AERs should be supported by all parts of the herb and dietary supplements industry. Prediction: Once such a system is established, it will show what many of us in the herb community have known for a long time—the vast majority of herbal dietary supplements are relatively safe, especially when compared to many over-the-counter and prescription drugs.