FDA CBD smack down offers chance for dietary supplement reforms

Although FDA has doubled down on its position that the existing dietary supplement regulatory framework is not appropriate—or sufficient—for addressing cannabidiol (CBD), a big question remains.

Could a modernized dietary supplement regulatory framework provide FDA the structure needed to regulate ingredients like CBD or any of the hundreds of cannabinoids, terpenes or other bioactive compounds that can be derived from hemp?

The Consumer Healthcare Products Association (CHPA) has long advocated for modernized dietary supplement regulations that would equip FDA with the tools it needs to stop criminals and improve its ability to regulate the market, which has exploded in size and scope since the original regulatory structure was developed.

Although the Dietary Supplement Health & Education Act of 1994 (DSHEA) originally established a strong and comprehensive regulatory framework where none existed before, nearly 30 years later, the law has not been modernized to keep pace with industry growth. This is a majorly missed opportunity to further advance supplement quality and safety for decades to come.

DSHEA should protect the 21st-century consumer who has access to an ever-expanding dietary supplement marketplace, a marketplace that could include cannabinoids being accepted as new dietary ingredients by FDA, if there were adequate guard rails to protect consumers.

Rather than suggesting CBD cannot be safely regulated, FDA’s announcement instead concludes a new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize potential risks related to CBD products. Risk management tools could include clear labeling, prevention of contaminants, CBD content limits and additional measures, such as a minimum purchase age to mitigate the risk of ingestion by children, FDA Principal Deputy Commissioner Janet Woodcock said in a written statement last month.

In fact, CHPA priorities for DSHEA modernization may address the concerns raised by FDA. These priorities include increased dietary supplement facility inspections through authorization of third party audits; a Dietary Supplement Master File (DSMF) system to ensure dietary supplements contain new dietary ingredients (NDIs) that have been FDA notified, as opposed to copycat NDIs that have not been reviewed for safety; and lastly, a widely debated mandatory product listing (MPL), which would allow FDA to efficiently monitor which CBD products enter the market to identify bad actors.

A core argument in support of FDA regulating CBD as a dietary ingredient under the current regulatory framework is the NDI review process gives FDA the opportunity to review each ingredient’s safety data on a case-by-case basis. Additionally, FDA reviews information about ingredient sourcing, manufacturing, composition, purity, delivery form, serving size, and importantly, the intended target population for use.

The NDI review process directly addresses concerns raised by FDA in its recent CBD conclusion. However, the challenge with the current regulatory framework is that after a sponsor invests in an NDI notification (NDIN) and successfully demonstrates the safety of its ingredient, there is no regulatory structure in place to help FDA monitor the market to identify and efficiently stop copycat ingredients with no safety evaluation from entering commerce. A dietary supplement listing would offer FDA, retailers, consumers, healthcare providers and manufacturers much-needed transparency into the market to differentiate products manufactured by responsible industry from those looking to evade FDA regulation.

Furthermore, a DSMF system could help ensure all CBD ingredients being sold have been evaluated as NDIs. Under this proposal, the first company to file for a specific ingredient would submit the safety data package as an DSMF. Any company not authorized to reference that DSMF must develop and file its own NDI. Entities intending to market the same NDI would obtain authorization from the DSMF owner to rely on the DSMF as part of their NDIN. In addition, an MPL would allow FDA to monitor the market to identify when products enter commerce that contain NDIs that have not been notified to the agency.

Another concern raised by FDA is the lack of “clear labels.” FDA may be referring to the confusion created by five years of non-regulated CBD labels that use marketing terms like “full-spectrum,” “broad spectrum,” “isolate,” or “delta-8” to describe CBD products. Labels and labeling terms are intended to help consumers decide which product to buy.

However, the CBD market has wildly misused terms to the point that misleading or inaccurate labeling could cause unintended consequences for consumers. For example, products labeled as dietary supplements and marketed as full spectrum “hemp” may contain THC levels that could result in a positive THC urine test, or in some extreme cases, exceed the THC levels permitted in some states where recreational cannabis is legal.

In the absence of a mechanism to efficiently monitor CBD product labels that enter the market, FDA could consider reining in CBD labels by developing a hemp product labeling guidance that provides clear definitions for terms used to describe hemp ingredients.

MPL would allow FDA to know when new CBD products are introduced, quickly identify and act against non-compliant labels, identify dangerous or otherwise illegal products, improve transparency, and promote risk-based regulation.

FDA has indicated its willingness to work with Congress to find a path for CBD products, but rather than creating a whole new pathway, stakeholders, including CHPA, believe this presents an opportunity to strengthen the existing framework for dietary supplements.

The combination of a DSFM and MPL could be the appropriate regulatory combination of risk management tools needed to help FDA more efficiently regulate and foster a market of “clear labels, prevention of contaminants and CBD content limits.” To ensure compliance, these regulatory modernizations could also be reinforced by increased facility inspections.

When DSHEA was passed, it was a historic agreement that preserved consumers’ right to access dietary supplements while also providing FDA the authority to protect the public from unsafe and unlawful products. Four years ago, then-FDA Commissioner Scott Gottlieb said “advances in science and the growth and development in the dietary supplement industry carries with it many new opportunities for consumers to improve their health. At the same time, the growth in the number of adulterated and misbranded products—including those spiked with drug ingredients not declared on their labels, misleading claims and other risks—creates new potential dangers.”

Of course, with rapid change and growth, comes increased risk and new challenges. At some point, the dietary supplement industry must come to terms with the fact that the desire to introduce cutting edge, innovative ingredients—including cannabinoids—comes with increased responsibility.

In fact, there are a myriad of exciting and potentially beneficial compounds that are found in plants and fungi that also contain intoxicating or hazardous substances. This is evidenced by the increasing interest in gray market products derived from kratom, hemp and ‘legal?’ psychedelic mushrooms like Amanita muscaria.

To safely market ingredients derived from these plants, there must be a comprehensive regulatory structure that can ensure products do not exceed safe intake levels or are not contaminated with the intoxicating parts of the plant. We also need assurances that these products are not consumed by sensitive sub-populations like children and pregnant women. And finally, there is the complicated question of what to do with the leftover intoxicants, like THC, that can be removed during processing, but put where?

While FDA’s recent CBD move may feel like an indirect smack down on dietary supplement innovation, we should use this as an opportunity to dictate the terms of needed regulatory reforms. These reforms could benefit both industry and consumers and ensure FDA has the appropriate authority and resources to oversee the continued success and innovation of the dietary supplement sector for decades to come.

Naturopathic doctor Duffy MacKay is the senior vice president of dietary supplements at the Consumer Healthcare Products Association (CHPA), where he leads the association’s dietary supplement scientific, policy and legislative initiatives. His career in supplements spans over 25 years and includes serving as a senior executive and scientist at leading dietary supplement companies, including CV Sciences, Nordic Naturals and Thorne Research.