FDA cracks down on dietary supplements

Original Post by: Daniel Takash

The FDA is on the hunt and dietary supplements are in its sites.

In April this year, the FDA expanded its policy of restricting the sale of adulterated dietary supplements containing untested additives. Many of the substances targeted are dangerous and worthy of restriction. The synthetic additive DMAA is one such example. Found in many popular supplements, the additive has been linked to cardiovascular problems and risk of heart attack. But not all cases are so clear cut.

On August 18, the FDA used its authority to restrict the sale and transportation of kratom, a product made from a tree related to coffee. Under the Food, Drug, and Cosmetic Act, a substance is considered “adulterated” and may be barred from interstate commerce if it contains an ingredient for which “there is inadequate information…that such ingredient does not present a significant or unreasonable risk of illness or injury”.

This guilty-until-proven-innocent approach is sensitive to alarmist news stories which subject regulators to public outcry. Regulators face serious trouble if they don’t restrict a drug that is perceived to be dangerous; their mistake will become front page news. But there is no such risk when prohibiting drugs with only positive effects. Consumers can’t miss drugs that are never made available.

Kratom has certainly produced some eye-grabbing headlines. The parents of a deceased student claim a kratom addiction led to his suicide last May. This local news article describes it as a legal heroin-LSD hybrid, and it has been associated with the “bath salt, sativa, spice crowd.”

While the media never misses negative headlines, coverage of the positive effects of kratom use is few and far between. For every cautionary tale of kratom use gone wrong, there are others where people have benefiting tremendously from its use.

One case study showed a patient who was able to alleviate the effects of opioid withdrawal by drinking kratom tea, and this is not the only recorded case of its use to treat withdrawal. Kratom has also been used as a painkiller and in other therapeutic treatments.

Its staunchest advocates, many of whom are recovering addicts, swear by it as a “life-saving medicine” in treating various conditions. In Thailand, it has been used to wean addicts off of heroin. Some are even proposing legalization after 70 years of prohibition as a way to combat methamphetamine abuse in the country.

Responsible regulators must make decisions based on sober analysis of all the available evidence. They must use a cost-benefit analysis to determine if the harm done to a few is greater than the benefits received by many.

Unfortunately, the FDA is utilizing a “ban first, ask questions later” approach that may cause more harm than the drug itself. It’s no surprise that when regulatory agencies restrict access to goods and services without clear evidence of harm, consumers are deprived of the benefits they provide.

There are reasonable issues of concern surrounding the use of kratom. A survey of kratom users in Malaysia near the Thai border revealed high rate of dependency and withdrawal. But many of these dependency issues only showed serious adverse side-effects for heavy use and they are no worse than many of the legal prescription opioids currently on the market. It is a glaring contradiction if FDA policy considers kratom to be more harmful than legal opioids, the addiction to which kratom can help to treat.

Of course, not every additive restricted by the FDA is harmless. Consumers can benefit from targeted regulation to ensure policies designed to handle a variety of different substances. However, these targeted regulations need to be designed based on demonstrable harms. Placing the burden of proving no risk is antithetical to a regulatory design that only restricts consumer choice in response to major hazards to public health.

Even when based on a realistic assessment of the risks, regulations must be written so the consumers who benefit from use still have access. This is especially true for kratom. Far from being a simple dietary supplement, it has helped those suffering from serious medical conditions.

Blanket bans in the name of consumer safety are not the solution. When the FDA restricts natural substances that already have established consumer markets along-side newly developed synthetic additives, it paints with an overly-broad brush.

The trepidation of regulators is understandable, but it is possible to be overly cautious in the field of consumer protection. Instead, regulators must examine already existing evidence for beneficial use and resist the urge to restrict access based on fear mongering.

Takash is a Young Voices Advocate, and a student at Johns Hopkins University.


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