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FDA proposes overhaul of dietary supplement industry
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FDA Commissioner Scott Gottlieb, MD, recently proposed several regulatory and communication initiatives that he said would lead to “one of the most significant modernizations of dietary supplement regulation" in nearly 3 decades.
According to a press release, Gottlieb seeks to: create a tool that quickly notifies the public and appropriate manufacturer when a product with an illegal or possibly dangerous ingredient is discovered; revisit the 1994 Dietary Supplement Health and Education Act that provides the current FDA regulations regarding dietary supplements, ensure the FDA regulatory framework is fluid enough to adequately assess product safety while encouraging innovation; and form new relationships and cultivate existing ones to achieve these objectives.
"Our first priority for dietary supplements is ensuring safety,” the commissioner said in the release. “Our second priority is maintaining product integrity: we want to ensure that dietary supplements contain the ingredients that they’re labeled to contain, and nothing else, and that those products are consistently manufactured according to quality standards. ... Our third priority is informed decision-making.”
Gottlieb noted the FDA’s announcement earlier this week that certain manufacturers received warning letters indicating the FDA’s awareness that their products that have not been approved and/or are misbranded as claiming to prevent, treat or cure Alzheimer’s disease is an example of what the initiative would do.
He also said additional steps regarding the proposed overhaul and meeting logistics detailing how the public can provide input on it are forthcoming. – by Janel Miller
Disclosures: Gottlieb is FDA commissioner.
Perspective
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C. Michael White, PharmD, FCP, FCCP
The dietary supplement world is a murky place where you spend your money on a product that may or may not have any active ingredient in it, may not contain the promised dosage or concentration of the active ingredient, or it might include adulterants and contaminants.
I have read and written about many examples of this.
For example, some natural products for male enhancement, muscle building and weight loss that have been adulterated with unlabeled prescription drugs, including those banned by the FDA because they have been proven to be unsafe. In addition, the dietary supplement Kava had been considered safe for years before cases of liver toxicity suddenly started popping up, leading to worldwide restrictions and cautionary messages from the FDA. Kava didn't suddenly become more dangerous; what likely occurred is that its growers started substituting a variety of the plant that grew faster to create greater yields, but the locals knew they should never use for medicinal purposes.
The list goes on: some kratom products contain a far greater concentration of 7-hydroxymitrogynine than would occur naturally, leading to suspicion that it is enriched with a chemical that has stronger opioid effects and addiction potential; some cannabidiol products had only 12.5% of vaporization liquids, 25% of tinctures, and 45% of oils labelled correctly (plus or minus 10% of the labeled value). In most cases, these products contained far less cannabidiol than promised and some cannabidiol products contain enough THC to put the user in legal jeopardy of marijuana possession. Some dietary supplements have been shown to contain excessive amounts of cancer-causing polycyclic aromatic hydrocarbons and contaminants such as heavy metals and mold.
How many more debacles must occur where the public trust is shoved aside to make a quick buck before people turn their back on natural remedies? The FDA can take decisive action that can reduce misinformation, fraud, abuse and unintentional poor cultivation and manufacturing practices. This can enhance the safety of dietary supplements sold in the U.S. and actually sustain this marketplace over the long-term.
No dietary supplement should be touted to prevent or cure any disease. Using a mouse study, in vitro cell study, or case report to market a dietary supplement’s disease modifying effects is fraudulent and hurts the public’s trust.
The FDA already had guidance on good manufacturing practices, but following them is not compulsory before placing a dietary supplement product on the U.S. market. Manufacturing plants, including those overseas, need to be personally inspected by the FDA. We know from the generic drug market and now the debacle with angiotensin receptor blocker manufacturers that the FDA’s history of inspecting foreign manufacturers is poor. Furthermore, all products should be tested periodically by an outside lab certifying that the products are free from contamination and adulteration, while possessing the promised dosage of the active ingredient, before it is allowed to be sold and randomly checked periodically thereafter. This would protect consumers and put the onus on the final manufacturer to ensure the quality of the products they are receiving from other cultivators or manufacturers. All of the costs of this outside testing should be borne by the manufacturers plus a surcharge to pay for additional FDA inspectors overseas. The current system where an overwhelmed FDA tries to fit in oversight of dietary supplements has to change.
Commissioner Gottlieb’s most recent proposal is sound and would go a long way in ensuring dietary supplement safety, but the agency will need a marked increase in resources to bring it to reality.
References:
Alltucker K, Hafner J. USA Today. “Why do blood pressure medications keep getting recalled? Here's what we do know.” Accessed Feb. 12, 2019.
Liva R. Integrative Medicine: A Clinican’s Journal. “Facing the problem of dietary-supplement heavy-metal contamination: How to take esponsible action.” Accessed Feb. 12, 2019.
Tournas VH. Journal of Food Safety. 2009;doi:10.1111.j.1745-4565.2009.00167
White CM. Am J Health Syst Pharm. 2018;doi:10.2146/ajhp161035.
White CM. J Clin Pharmacol. 2018;doi:10.1002/jcph.1263.
White CM. J Clin Pharmacol. 2019;doi:10.1002/jcph.1387.
White CM. The conversation. “Beware of natural supplements for sex gain and weight loss.” Accessed Feb. 12, 2019.
Perspective
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Jeff Pilz, PharmD, BCPS
The pendulum for the FDA assuming a greater role in the regulation of dietary supplement products has swung back and forth multiple times since the agency received regulatory authority over drugs in 1938.
Unlike prescription medications, which must receive FDA approval prior to marketing, dietary and herbal supplements may be marketed without research on their safety and efficacy. The FDA must prove products to be unsafe to have them removed, which can be difficult. Consumers also need to be aware of adulterated or misbranded supplements, including those not made in accordance with good manufacturing principles. The rise in online shopping has greatly expanded the dietary supplement market and made this concern regarding the honesty and integrity of some dietary supplements much more significant.
However, Commissioner Gottlieb’s plan makes no mention of the fact that the Federal Trade Commission as some authority regarding these products, in terms of ensuring consumers receive accurate information about dietary supplements to make informed decisions. There is no mention of how the FTC and FDA would work together on his proposed initiatives.
I am also wary of how much of his idea could be implemented since the 1994 Dietary Supplement Health and Education Act limited the scope of what the FDA can do in this area. The FDA has maximized its authority in many ways without significant changes to that law, but further action would likely require legislative action. I’m not sure the current political climate feels strongly enough one way or another on this topic to undergo a major rewrite of that law. Even if there were more substantive changes, the FDA has limited staff and budgetary resources which could be a barrier to this plan’s success.
Bottom line, the intent behind Commissioner Gottlieb’s announcement is good and long overdue but I would have to wait for more details to determine the impact on the supplement industry. Regardless of the FDA changes, pharmacists are an excellent resource who can provide evidence-based recommendations on dietary supplement manufacturers, dosing, and safe use.
, The Ohio State University Wexner Medical Center
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