Natural health and integrative medicine recently won a court victory, and it is worth taking a bit of time to understand what it means.
The FTC (Federal Trade Commission) filed an action in federal district court asking that Lane Labs be held in contempt for violating a 2000 consent order to refrain from making representations regarding the effect of any health product without being able to support those claims with reliable scientific evidence. The FTC filed this action even though Lane Labs had submitted compliance reports including extensive scientific backing for any claims made. After remaining silent for 6 years, the Agency suddenly petitioned the court to hold Lane Labs in contempt despite all the company’s efforts.
The court ruled in favor of Lane Labs. It held that the government failed to meet its burden of providing clear and convincing evidence that Lane Labs made claims without credible evidence to back them up. Key to the court’s decision was the fact that two expert witnesses testified as to the credibility of the claims made by Lane Labs. The opposing views presented by the expert witnesses for the FTC and for Lane Labs amounted to what the court considered a difference of opinion, not enough to meet the evidentiary burden required to grant the government’s motion. This outcome may seem self-evident to an impartial observer, but courts often seem reluctant to rule against government agencies.
FTC vs. FDA Authority
The Food and Drug Administration and the Federal Trade Commission are different agencies with overlapping authority over the advertising of dietary supplements. Basically, the FTC is responsible for enforcing laws that prevent manufacturers from making misleading, false, or fraudulent claims about their products on product packaging or in advertising. The FDA is responsible for enforcing laws that prevent manufacturers from selling adulterated (impure) or misbranded product. But the FDA’s definition of misbranded is very loose and even includes the dissemination of truthful scientific evidence. Even a true statement in the FDA’s eyes may be classified as “false” and thus misbranded. So in many cases, either the FTC or the FDA may object to the same statement. In the case of Lane Labs, it was the FTC which was claiming false advertising.
Structure/function Claims
Structure/function claims are claims about a product’s affect on the structure or function of the body. Food and dietary supplement manufacturers are explicitly allowed by statute to make such claims without having to worry about their product being classified as a drug. “Supports the immune system” is an example of a structure or function claim. The claims made by Lane Labs were structure/function claims, not disease claims that would have required FDA approval. In addition, they were advertising claims.
What This Ruling Means For Manufacturers
It is not up to the FTC to decide what represents credible scientific backing for a claim. The agency must be reasonable and where diverse interpretations of scientific evidence represent differences of opinion rather than discredited positions, government policy must allow for that diversity instead of suppressing points of view it disagrees with. ANH-US is engaged in a similar battle right now with the FDA, suing the FDA for violating the first amendment rights of members to make certain qualified health claims. The court’s rebuke of the FTC should apply to the FDA as well: if manufacturers are making honest claims and have proof to back them up, no government agency should prevent them from communicating information to consumers.