Appeal court reaffirms validity of structure/function claims in biotin lawsuit

By Hank Schultz contact

- Last updated on GMT

©Getty Images - serggn
©Getty Images - serggn

Related tags: biotin, Hair care ingredient, Vitamins, structure/function claims

An appellate court ruling that reaffirms the validity of structure/function claims is good news for the dietary supplement industry, an attorney says.

Katie Bond, who is now with the law firm Lathrop GPM, said the ruling came in a case brought against Target and contract manufacturer International Vitamin Corporation and concerned structure/function claims for the ingredient biotin, which has been considered one of the B vitamins.  Bond wrote an amicus brief in the case on behalf of the Council for Responsible Nutrition (CRN).

Plaintiff claimed structure/function claim was misleading

The case was brought on behalf of a consumer who was trying to stem his hair loss.  His complaint allegedly stemmed from a bottle of Up & Up brand biotin he purchased at Target that bore the structure/function claim “helps support healthy hair and skin.” 

He allegedly purchased the product in the belief that it would help prevent his hair loss. The plaintiff was allegedly motivated to file suit when he discovered that few Americans are deficient in biotin and that additional amounts of biotin do not treat hair loss.

Bond said the ruling authored by Ninth Circuit Court of Appeals judge Kenneth Lee is significant in that it affirms that structure/function claims can be based on scientific evidence of  the benefits nutrients can have in avoiding the problems that arise from deficiencies.  In other words, the structure/function benefit applies to all even if, as is usually the case, the individual consumer is not actually deficient in that particular nutrient.

“The government doesn’t force companies to know how their consumers are taking in their nutrients”​ Bond said. 

“It’s good news because this cuts off a line of attack that plaintiffs’ law firms have been using. There had wave of class actions that were targeting biotin supplements that were making hair, nail and skin claims,”​ she added.

Issue resolved as one case finally goes to trial

Bond said it was a welcome development that one of these cases finally went through to trial and was affirmed in an appellate court ruling.  Many of the other cases had been settled out of court by companies making payments in respond to demand letters.

Bond said the ruling is likely to set a strong precedent for many kinds of structure/function claims, not just those pertaining to biotin and its benefits for healthy hair.

“I think this will give a big level of protection for any structure/function claim that is based on deficiency evidence,”​ she said.

CRN: Ruling protects flow of health benefit information

Megan Olsen, vice president and general counsel of CRN, had this to say about the ruling and the role CRN’s amicus brief had to play: 

“CRN is pleased with the recent ruling from the Ninth Circuit Court of Appeals regarding the dietary supplement, biotin. The Court upheld a previous decision of the U.S. District Court for the Northern District of California that found federal law expressly preempts the claims of the plaintiff. We applaud this decision as it protects both industry and consumers by maintaining the federal framework, allowing dietary supplement manufacturers to disseminate information about how nutrients affect the health and function of the body and empowering consumers to make informed choices about nutrition.

“CRN recognizes the importance of filing these amicus briefs on behalf of industry to protect the federal standards that are in place and prevent private actors from overhauling this carefully crafted framework and creating a patchwork of conflicting substantiation standards inconsistent with the federal system.”

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