Historically, approximately 70% of dietary supplement notifications to FDA were rejected. This high rejection rate has had a chilling effect on submission of notifications for new dietary supplement ingredients. These rejections were usually not based on a specific violation of the Act (i.e., Dietary Supplement Health and Education Act), but one of many administrative state tools used by FDA to thwart implementation of a statute with which FDA did not agree including, but not limited to“Chevron deference1”, “Skidmore deference2”, “Auer deference3” “non-binding” guidance or, more recently, “frequently asked questions”. However, many of these administrative state tools may be voided with President Donald Trump’s Executive Order 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents” which may result in a flood of new notifications and possibly even re-submission of previously rejected notifications.
What would cause the FDA to disagree and avoid compliance with a law passed specifically to legitimize the use of dietary supplements which had been in regulatory purgatory for so long? Probably because of FDA’s memory of reckless profiteers from a century ago. At the turn of the 20th century, a large segment of the US population lived a subsistent agrarian existence and another large portion consisted of immigrants crammed into tenements and living under conditions unimaginable by today’s standards. These people were often illiterate, uneducated, undernourished, impoverished and had a life expectancy of 46-48 years of age. They made an easy target for the promises of “patent” medicines, fraudulent product claims and phony therapeutic regimens. Much of the marketing claims made at the time seem at best, silly to us today, and at worst, dangerous to the consumer. Even the middle and upper economic classes of the time were not immune to seductive advertisements about miracle cures making unsubstantiated and sometimes ludicrous claims.
Subsequent amendments to the Federal Food Drug and Cosmetic Act mandated improved safety standards for products through pre-market testing and claims subjected to a greater level of scrutiny and substantiation. Still, the FDA was unwilling to cede ground, feeling that consumer fraud and the flow of substandard products were largely unabated and that consumers might chose to take a supplement instead of seeking necessary medical treatment.
Nonetheless, for all the above stated reasons, FDA has prevented consumer access to potentially beneficial products, typically by requesting additional, costly and time-consuming studies that are outside the typical requirement even for food. Unfortunately, this reluctance to implement the Act as intended by Congress may have the net effect of endangering the safety of the consumer. That is, because FDA has set the bar so high for qualification as a notified supplement by demanding such a rigorous testing portfolio (higher than required for a generally recognized as safe (GRAS)), many manufacturers have chosen to by-pass the notification process. The rationale given for by-passing the notification process is because of the costs of compliance required by “non-binding” guidance and the potential of denial of a notification “filing”, the latter of which would stigmatize the product. The high bar set by the Office of Dietary Supplements therefore actually incentivizes producers not to notify and, because so few substances are granted “filed4” status, the consumer assumes truth in the urban legend that supplements are not regulated.
So what will change with the Executive Order and are there any other potential changes that may affect supplement notifications? There are two things that may produce a more friendly regulatory climate: (1) President Trump’s Executive Order 13891 prohibits federal administrative agencies from issuing binding rules through “non-binding” guidance documents or other non-public requirements, such as opinion letters, policy statements, agency manuals, etc. (i.e., Skidmore deference). As a result, it is likely that a number of companies, initially put-off with the high testing standards and not submitting a notification and those denied a “filing” of their dietary supplement notification could come back to FDA demanding the agency reconsider its initial denial. (2) The other effect will be the decision of a more conservative Supreme Court to rule the “Chevron Deference” finding as unconstitutional.5 With the defeat of Chevron Deference, will likely also be the death of Skidmore and Auer deferences and result in even more new notifications, not just for dietary supplement ingredients, but GRASes and GRASes for medical foods.
A word of caution. Even though the Executive Order may set aside these extra-regulatory hurdles, FDA will still have ample room for disqualification of a notification that is weak, unpersuasive, lacking documentation, supported by non-English publications, lacking specifications or inadequate description of taxonomy for a plant-based ingredient. A successful notification requires meeting both regulatory and common-sense requirements and, most of all, should be persuasive – the agency does not respond well to a “data dump”. Burdock Group has considerable experience with FDA and is your go-to company for a successful notification.
- Under Chevron deference, a federal court must defer to an agency’s interpretation of a statute that the agency administers if the underlying statute is unclear and the agency’s interpretation is deemed reasonable.” https://ballotpedia.org/Deference_(administrative_state)
- Skidmore deference is applied to agency interpretations “such as those in opinion letters—like interpretations contained in policy statements, agency manuals, and enforcement guidelines.” https://ballotpedia.org/Deference_(administrative_state)
- Under Auer deference, a federal court must defer to an agency’s interpretation of an ambiguous regulation that the agency has promulgated. https://ballotpedia.org/Deference_(administrative_state)
- Which amounts to a pre-market notification, an action prohibited by DSHEA.
- Landmon et al. Food and Drug Law Journal 74:338, 2019.