Enforcement of FDA qualified health claims: Who’s on the case?
For those charged with ensuring regulatory compliance for a company’s products, enforcement agencies like the Food and Drug Administration (FDA) may be a dogged adversary, doling out warning letters and threatening injunctions until, like a regulatory Columbo, they get their man. But in at least one circumstance — qualified health claims — the FDA may seem a bit more like Inspector Clouseau. A recent false advertising case against Gerber promises to shed light on whether competitors, consumers, the FTC, the FDA or perhaps nobody at all is on the case when it comes to challenging overstated qualified health claims.
The scene of the tort
The recently filed suit, Federal Trade Commission v. Gerber Products Co., alleges that Gerber violated the FTC Act provisions prohibiting deceptive practices by advertising its Good Start Gentle baby food as reducing the risk of food allergies. The product packaging includes an emblem that reads “1st and Only to Meet FDA Qualified Health Claim,” and television advertisements proclaim that “you want your Gerber baby to have your imagination … your eyes … not your allergies.” The FTC alleges that these advertisements are deceptive because they overstate the health claim approved by the FDA.
The FDA created guidelines for qualified health claims in 2003, in response to the case Pearson v. Shalala, which held that the exacting “significant scientific agreement” required for health claims infringed upon advertisers’ free speech. And so qualified health claims were born, which require less scientific agreement but must carry disclaimer language so as not to mislead consumers. Claims that have been allowed include that there is “very little scientific evidence” that “whole grains may reduce the risk of Type 2 Diabetes,” and that the “FDA does not endorse” the claim that folic acid reduces the risk of neural tube defects. Not exactly the type of ringing endorsement that might convince Hercule Poirot to take a B9 supplement.
With such unflatteringly qualified language one might think qualified health claims would be unpopular. Indeed, the FDA has approved only 29 qualified health claim petitions in total and denied 15 others (many of which were revised and approved). However, you need not be the petitioner to slap a qualified health claim on your product. Once a claim has been approved, any company can co-opt the language. And many do.
Gerber hoped to advertise that its Whey-Protein Partially Hydrolyzed infant formula helped reduce the risk of developing food allergies. Its broad 2005 petition was rejected as lacking sufficient scientific support, so Gerber petitioned again in 2009 with a narrower claim — that its formula may reduce the risk of atopic dermatitis. The FDA approved, providing that Gerber heavily qualify its claims with some variation of the following: “[v]ery little scientific evidence suggests that, for healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow's milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life and up to 3 years of age.” The FTC sued because they allege Gerber overstepped the bounds of the FDA’s approval by making claims without the required qualifications.
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Who’s on the case?
An interesting aspect of qualified health claims is the apparent uncertainty over whose job it is to police them. False advertising claims may be brought by consumers, competitors or the FTC, but a slew of cases in 2014 suggest that overstatements of FDA approval may be barred by primary jurisdiction or preclusion challenges. Preclusion arises when a claim directly conflicts with an FDA determination or necessarily requires interpretation of the FDCA. Primary jurisdiction is broader and allows the court discretion to dismiss or stay claims to give the FDA a chance to weigh in.
The legal duo of preclusion and primary jurisdiction has been a veritable Crockett and Tubbs of legal defenses, providing some successful strategies for false advertising defendants. In Catheter Connections v. Ivera Medical, the plaintiff sued its competitor for misrepresenting that a new version of its device did not need premarket approval by the FDA, where the FDA hadn’t yet weighed in. The court held that the claim was precluded because whether or not the defendant complied with FDA regulations was an issue for the FDA alone to address. In JHP Pharmaceuticals v. Hospira, a competitor brought false advertising claims based in part on representations that the defendant’s product abided by all applicable laws when it had not received FDA approval. The court dismissed the claims as being within the FDA’s primary jurisdiction. Finally, in Apotex v. Acorda Therapeutics, a competitor alleged that the defendant’s promotional claims misleadingly deviated from FDA approved label language. The court granted summary judgment on the Lanham Act claims, holding that “[a] promotional claim is not literally false simply because it exaggerates an FDA-approved statement.” In each instance the prospective enforcer was stymied by its intrusion into the FDA’s realm. With the Gerber case, we may see whether the FTC will meet a similar fate.
Getting the FDA to step in, however, has proven as difficult as getting the corpulent Nero Wolfe to leave his brownstone. The FDA has issued only seven warning letters referencing qualified health claims (including one to Gerber). Defendants might also take comfort in recent statements by the FDA Deputy Commissioner for Foods indicating that promotional health-related claims are not a high enforcement priority. The implicit suggestion is that once a claim is dismissed on primary jurisdiction or preclusion grounds, subsequent action by the FDA may be unlikely.
Thus, while deviating from or misrepresenting FDA approvals may result in a false advertising lawsuit by competitors, consumers or the FTC, those plaintiffs may find themselves stymied by the jurisdiction of an unconcerned FDA. Of course, the safer bet is to carefully avoid potential liability in the first place by constraining advertising to the precise language approved by the FDA, disclaimers and all. After all, even Inspector Clouseau caught the Phantom in the end.
The scene of the tort
The recently filed suit, Federal Trade Commission v. Gerber Products Co., alleges that Gerber violated the FTC Act provisions prohibiting deceptive practices by advertising its Good Start Gentle baby food as reducing the risk of food allergies. The product packaging includes an emblem that reads “1st and Only to Meet FDA Qualified Health Claim,” and television advertisements proclaim that “you want your Gerber baby to have your imagination … your eyes … not your allergies.” The FTC alleges that these advertisements are deceptive because they overstate the health claim approved by the FDA.
The FDA created guidelines for qualified health claims in 2003, in response to the case Pearson v. Shalala, which held that the exacting “significant scientific agreement” required for health claims infringed upon advertisers’ free speech. And so qualified health claims were born, which require less scientific agreement but must carry disclaimer language so as not to mislead consumers. Claims that have been allowed include that there is “very little scientific evidence” that “whole grains may reduce the risk of Type 2 Diabetes,” and that the “FDA does not endorse” the claim that folic acid reduces the risk of neural tube defects. Not exactly the type of ringing endorsement that might convince Hercule Poirot to take a B9 supplement.
With such unflatteringly qualified language one might think qualified health claims would be unpopular. Indeed, the FDA has approved only 29 qualified health claim petitions in total and denied 15 others (many of which were revised and approved). However, you need not be the petitioner to slap a qualified health claim on your product. Once a claim has been approved, any company can co-opt the language. And many do.
Gerber hoped to advertise that its Whey-Protein Partially Hydrolyzed infant formula helped reduce the risk of developing food allergies. Its broad 2005 petition was rejected as lacking sufficient scientific support, so Gerber petitioned again in 2009 with a narrower claim — that its formula may reduce the risk of atopic dermatitis. The FDA approved, providing that Gerber heavily qualify its claims with some variation of the following: “[v]ery little scientific evidence suggests that, for healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow's milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life and up to 3 years of age.” The FTC sued because they allege Gerber overstepped the bounds of the FDA’s approval by making claims without the required qualifications.
__________________________________________________________
RELATED STORIES:
The ins and outs of amicus briefing: The increasing influence of amicus briefs
Worth the candle? Deference to a trial court’s finding of facts in claim construction
Microsoft settles suit with patent troll
________________________________________________
Who’s on the case?
An interesting aspect of qualified health claims is the apparent uncertainty over whose job it is to police them. False advertising claims may be brought by consumers, competitors or the FTC, but a slew of cases in 2014 suggest that overstatements of FDA approval may be barred by primary jurisdiction or preclusion challenges. Preclusion arises when a claim directly conflicts with an FDA determination or necessarily requires interpretation of the FDCA. Primary jurisdiction is broader and allows the court discretion to dismiss or stay claims to give the FDA a chance to weigh in.
The legal duo of preclusion and primary jurisdiction has been a veritable Crockett and Tubbs of legal defenses, providing some successful strategies for false advertising defendants. In Catheter Connections v. Ivera Medical, the plaintiff sued its competitor for misrepresenting that a new version of its device did not need premarket approval by the FDA, where the FDA hadn’t yet weighed in. The court held that the claim was precluded because whether or not the defendant complied with FDA regulations was an issue for the FDA alone to address. In JHP Pharmaceuticals v. Hospira, a competitor brought false advertising claims based in part on representations that the defendant’s product abided by all applicable laws when it had not received FDA approval. The court dismissed the claims as being within the FDA’s primary jurisdiction. Finally, in Apotex v. Acorda Therapeutics, a competitor alleged that the defendant’s promotional claims misleadingly deviated from FDA approved label language. The court granted summary judgment on the Lanham Act claims, holding that “[a] promotional claim is not literally false simply because it exaggerates an FDA-approved statement.” In each instance the prospective enforcer was stymied by its intrusion into the FDA’s realm. With the Gerber case, we may see whether the FTC will meet a similar fate.
Getting the FDA to step in, however, has proven as difficult as getting the corpulent Nero Wolfe to leave his brownstone. The FDA has issued only seven warning letters referencing qualified health claims (including one to Gerber). Defendants might also take comfort in recent statements by the FDA Deputy Commissioner for Foods indicating that promotional health-related claims are not a high enforcement priority. The implicit suggestion is that once a claim is dismissed on primary jurisdiction or preclusion grounds, subsequent action by the FDA may be unlikely.
Thus, while deviating from or misrepresenting FDA approvals may result in a false advertising lawsuit by competitors, consumers or the FTC, those plaintiffs may find themselves stymied by the jurisdiction of an unconcerned FDA. Of course, the safer bet is to carefully avoid potential liability in the first place by constraining advertising to the precise language approved by the FDA, disclaimers and all. After all, even Inspector Clouseau caught the Phantom in the end.
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