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What Do Fishermen and Dietary Supplements Have in Common?

What Do Fishermen and Dietary Supplements Have in Common?
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A 40-year old Supreme Court case has given federal agencies a blank check to abuse their power, but all of that could be coming to an end. Here’s what that means for natural health.

The U.S. Supreme Court has agreed to reconsider a decades-old decision that, if reversed, will curb the power of federal agencies. In Chevron v. Natural Resources Defense Council, the Supreme Court ruled that, when a law passed by Congress is unclear or ambiguous on a topic, courts should defer to a federal agency’s interpretation of the statute. This makes it extremely difficult for anyone to challenge federal agencies’ interpretation of the law and has had a direct negative consequence for supplements and the natural products industry. Among the many possible results if the so-called “Chevron doctrine” is overturned, many potential avenues open up to challenge FDA and FTC interpretations that have limited access to and information about supplements.

The case that will be heard by the Supreme Court challenging the Chevron doctrine has been brought by a group of commercial fishing companies challenging a rule issued by the National Marine Fisheries Service requiring the fishermen to pay for the costs of observers that ensure regulatory compliance with federal fishing rules. While the law states that the government can require fishing boats to carry monitors, it does not specify who pays for them. But with the precedent in Chevron, lower courts hearing the fishermen’s case deferred to the interpretation of the federal agency, which said the fishermen should pay for the observers. Now the case will be heard by the Supreme Court, which will specifically reconsider its ruling on Chevron.

It’s hard to overstate how game-changing this decision could be. Look back through the archives of ANH’s Pulse of Natural Health newsletter, and notice how many times we are writing about how the FDA or FTC are working to limit access to natural medicines. In many cases this is done through an overreach because the agency is taking liberties with the law. Here are a few examples:

  • Implied disease claims. Federal law allows supplement companies to make claims related to how a nutrient effects the structure or function of the body, as long as they aren’t claiming to treat or prevent a disease. But the FDA has denied many truthful claims because it interprets them as “implied” disease claims. So, the truthful claim that chromium lowers blood sugar, for example, is banned because, according to the FDA, this is an “implied” disease claim that chromium treats diabetes. This and other claims have been denied on the basis of an FDA interpretation of the law, so if Chevron were overturned, stakeholders could more easily challenge the FDA to allow these claims so consumers are better informed about products that can improve health.

  • Health claim substantiation. We recently covered the FTC’s shot across the bow to the natural products industry, putting them on notice that clinical trials will be needed to substantiate health-related advertising claims. This comes down to the FTC’s interpretation of what constitutes “competent and reliable” scientific evidence, with the agency setting the bar at clinical trials because supplement companies can’t afford to do them. The result will be fewer health claims about vitamins, minerals, and other nutrients. The FDA has done something similar in its interpretation of what constitutes “significant scientific agreement,” which is required for the approval of certain supplement health claims. Again, due to agency interpretations of the law, consumers are denied access to crucial health information.

  • “New” supplements. The law considers ingredients “marketed in or as” supplements in the US after 1994 as “new” and those “marketed in or as” supplements before 1994 as “old.” “New” supplements must comply with so-called “new dietary ingredient” (NDI) regulations. But ambiguities exist about what it means to be “marketed” for the purpose of determining if a supplement is considered “old” or “new.” The FDA successfully argued in court that “marketed as” is not the same as “sold as.” This is crucial, as it means that the mere presence of an ingredient in food is not sufficient evidence to prove prior marketing of the ingredient. Resveratrol has been present in the food supply in grapes forever, but this doesn’t mean it was “marketed as” a supplement for the purposes of determining if resveratrol is “old” or “new.” This interpretation means many ingredients would need to comply with NDI regulations, which are costly and burdensome—and if they don’t, drug companies can snatch them up and turn them into drugs via the back-channel that exists at the FDA. A plain reading of the law is that a dietary ingredient sold in the food supply before October 1994, whether as an ingredient in food or dietary supplements, is grandfathered and excluded from the NDI provisions.

If your eyes glazed over reading some of that legal jargon, the simple takeaway is that agencies like the FDA and FTC have had, because of Chevron, greater leeway to restrict access to and censor information about supplements you care about. If SCOTUS reverses Chevron, the floodgates could be open to legal challenges against the FDA and the FTC for the arbitrary and restrictive interpretations of the law they’ve been engaging in for decades.

We will monitor the results of this case closely and keep you informed of any developments.

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