The problem of excluding drugs from the food supplement industry


If you like something, release it. If he comes back and bites you, then it’s time to make a change. So maybe these aren’t exactly the lyrics to Sting’s hit song in 1985, but that’s what happens today with what was once an obscure provision of the Health and Safety Act. Dietary Supplement Education (DSHEA). Section 201 (ff) (3) (B) of the Food Drug & Cosmetic (FD&C) Act (codified at 21 USC 321 (ff) (3) (B)) – sometimes referred to as the “drug exclusion provision” —Is increasingly used to prevent or withdraw safe and legitimate food ingredients from the market. It is time to change that.

After the FD&C law lists the types of ingredients that a dietary supplement must contain, the exclusion clause states that a dietary supplement cannot include an item that has already been approved as a new drug, or an item authorized for investigation as a new medicinal product for which substantial clinical investigations have been instituted and made public, before its marketing as a dietary supplement.

This provision creates a race between drugs and supplements that use the same item as an ingredient: if the supplement is already marketed before the drug enters, the two products must coexist in the market (e.g. omega 3, niacin and vitamin D, all of which currently can be found in the form of supplements and prescription drugs). But if the drug comes in first, either by entering the market as a drug or by having been studied in a clinical investigation, the drug gets the monopoly of the article.

This provision was inserted into the DSHEA to satisfy a congressman concerned that companies might choose to market a substance as a supplement after a competitor has spent years conducting expensive pharmaceutical research and frustrating incentives. drug research and development.

During the first five years under DSHEA, the provision went largely unnoticed. However, it drew attention in the remarkable case of Pharmanex v. Shalala when the FDA announced that red yeast rice could not be marketed for its monacolin (lovastatin) content because prescription drugs containing statins were already on the market before the company started promoting yeast rice red for its monacoline. In a decision of the United States Court of Appeals, Tenth Circuit, the court ruled that monacolin cannot be marketed as a supplement. However, red yeast rice could continue to be sold with its natural levels of monacolin as long as these levels were not manipulated or standardized to achieve a specific dosage or marketed for these levels. Note that the court never considered the safety issue of the supplement; the debate was more about setting up sufficient economic incentives to promote pharmaceutical research.

Then, in 2009, the FDA withdrew pyridoxamine (a form of vitamin B6) from the supplement market when it invoked the exclusion clause and claimed there was no evidence the item was in commerce. as a supplement before the start of clinical trials for the ingredient as a drug product. Otherwise, little attention has been paid to the implications of excluding drugs at the expense of supplements.

Fast forward to 2019 and legislation to remove cannabidiol (CBD) from the lists of controlled substances – the Farm Bill 2018 (adopted in December of the same year) removed hemp with a THC content of less than 0.3 % of lists. The FDA quickly cited 201 (ff) (3) (B) to argue that, nevertheless, CBD cannot be a dietary ingredient due to Epidiolex’s pre-approval as a drug. This artificial barrier has frustrated mainstream retailers from selling ingestible CBD products for more than two years.

The FDA again invoked the ban last summer, this time to attack the legal sale of N-acetyl-l-cysteine ​​(NAC) and issued warning letters citing drug approval for an inhalable version of NAC dating back to 1963. The FDA has asserted that the exclusionary provision enacted in 1994 is retroactive to preventing supplements containing an ingredient that was investigated long before the protections were made. innovation of section 201 does not exist. The agency ignored differences in the form of delivery (inhaled versus ingested), different dosage levels, and very different indications in an attempt to remove a long-standing safe and popular ingredient from the supplement market. Unfortunately, other dietary ingredients on the market today, and potential ones in the future, could be excluded, as could CBD and NAC.

The law provides for an emergency exit. The end of the provision on the prohibition of drugs states: “… unless the secretary [of Health and Human Services], at the discretion of the secretary, issued a regulation, after notice and commentary, concluding that the section would be lawful under this chapter. The agency has the possibility of resolving these conflicts when they arise with a regulation which grants an exception to the legal race to the market. So even if the “item” is the same for the drug and the supplement – and there are good reasons why they are not the same – the FDA might fix the problem. Unfortunately, the FDA has never exercised this authority and seems reluctant to do so now for NAC or CBD.

It is important to remember that safety is not the issue in these cases; it is a purely economic argument to preserve financial incentives to conduct drug research. Does the law say that safety should even be a consideration? It does not tell the FDA how to determine that the item “would be lawful under this chapter.” If it is possible to label and market the item as a supplement without presenting a significant and unreasonable risk of injury or illness, is that sufficient? If it was first marketed as a supplement after 1994, under a New Food Ingredient Notification (NDI), is that sufficient to show that the ingredient is reasonably expected to be safe? Or that it is marketed for a different indication than its pharmaceutical counterpart?

All of this underscores the need for a reconsideration of the exclusion clause. The FDA could issue guidelines on this matter, but failing that, Congress must revise this section of the law. This market race should not protect pharmaceutical interests at the cost of denying consumers access to effective supplements that can treat common health problems.

This problem will arise more and more often as drug companies examine the ingredients of long-standing supplements for their potential therapeutic effects and wish to “clean up the bridges” of all the supplements on the market that could reduce their ability to charge more. the drug version. Think about NAC: you can buy an extra 600 mg of NAC for less than 33 cents per serving. A 200-unit bottle can sell for less than the typical $ 20 copayment of a prescription drug. If you thought that NAC also has a therapeutic effect for COVID patients, you would want to corner the market as well.

The provision should not put back legitimate food ingredients because a clinical trial investigated a disease endpoint years ago. The industry needs clarity and balance as the motivation for supply is economic to protect the investments and incentives of large pharmaceutical companies to do drug research – innovation and complementary research should also count.

We are in a difficult situation right now and it is time to resolve it before we lose other safe and beneficial ingredients in the name of pharmaceutical innovation.

Steve Mister is President and CEO of the Council for Responsible Nutrition.


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