Similar to common dietary supplements that are regulated by the U.S. Food and Drug Administration (FDA), health preparations are often the preferred choice for those opting to live a holistic lifestyle. Herbalists, who may use natural ingredients such as herbs to create their own health preparations, must operate within the rules and guidelines of the FDA regarding the formulation and distribution of herbal supplementation.
Recently, the FDA revealed plans to update the depth and breadth of its regulation of these types of products.
According to then-FDA Commissioner Scott Gottlieb, M.D.,
Dr. Gottlieb announced several initiatives to increase FDA oversight (U.S. Food and Drug Administration [FDA], 2019a), including the following, which are of particular interest to herbalists:
Continued focus on “compliance and enforcement efforts against firms that have shown persistent inability to comply with the current good manufacturing practice requirements for dietary supplements” (FDA, 2019a, para. 20).
Engagement in a public dialogue to determine whether or not updates are needed to modernize the Dietary Supplement Health and Education Act (DSHEA), the regulations governing dietary supplements, particularly in the area of a mandatory dietary supplement product registration.
In addition, the ingredients commonly used by pharmacists and naturopaths to make compound medicines are also being reevaluated.
Over the past few years, the FDA has increased action towards the smaller herbal products businesses whose practices are not in compliance with the Dietary Supplement and Health Education Act of 1994. Warning letters issued to offenders often cite “a lack of compliance with current Good Manufacturing Practices (cGMPs) and/or labeling requirements, particularly in terms of the inclusion of what they define as drug claims or structure/function claims on product labels without appropriate pre-approval and/or substantiation.”
Although the re-evaluations are already underway, the process is not expected to have a dramatic effect on the industry. Rather, the announcement was meant to affirm the direction the FDA has been taking for the past 1 – 3 years.
How Will Herbalists Be Affected?
While herbalists operating smaller, hands-on ‘mom and pop’ businesses may be justified in feeling that the focus should be placed on the big companies who import obscure ingredients from foreign countries, the FDA does not differentiate between the two. From a legal standpoint, the regulations are the same across the board. Therefore, it is the herbalist’s responsibility to be sure they’re operating within the mandatory guidelines.
In former Commissioner Gottlieb’s words,
“Industry stakeholders have suggested that the statute should be amended to establish avenues for dietary supplement exclusivity and add a product listing requirement. A mandatory listing requirement could provide significant benefits by improving transparency in the marketplace and promoting risk-based regulation. It could also help facilitate efficient enforcement of the law and establish new mechanisms to identify bad actors who put the public at risk and undermine consumer confidence in the entire industry” (FDA, 2019a, para. 21).
Read the full article here to learn how ‘compounders,’ physicians, pharmacists, practitioners and naturopaths could be potentially affected by more stringent FDA guidelines pertaining to herbal supplementation.
While it is the FDA’s goal to protect consumers, the proposed changes present an opportunity for herbalists to stay informed and to advocate on behalf of the natural products industry.
*Article originally appeared at The Herbal Academy.