Fairy dusting with high value ingredients and borrowing someone else’s science to support your own claims are just two of the ways that the POM vs Coke case could impact dietary supplements, and the implications could extend to advertising as well as labeling, says Loren Israelsen.
The Supreme Court recently ruled that POM may proceed with a lawsuit against Coca-Cola for allegedly deceptive labeling and advertising of a pomegranate/blueberry juice product. A lower court had ruled (in line with past rulings) that because the labels of the product in question were compliant with the Food Drug and Cosmetic Act and were regulated by FDA, POM had no standing to sue under the Lanham Act (unfair competition).
Now that POM can proceed, the question is whether the ruling will bring forth a wave of lawsuits, one company suing another over alleged deceptive labeling practices. In the POM case, POM had originally sought to sue Coca-Cola over its practice of presenting its Minute Maid Pomegranate/Blueberry product as being the juice of those fruits, when in fact it had so little (0.5%) that they contributed only coloring and flavoring. POM claimed its business was damaged because consumers were buying the competing product thinking they could get the health benefits of those juices at a lower price.
A sudden burst of lawsuits…
In an exclusive briefing for UNPA members on June 20, Israelsen told listeners that the POM vs Coke ruling has multiple implications for the dietary supplement players, and could touch on science (is it your science you are quoting to support a products potential benefits or have you borrowed it from a competitor?), structure function claims (what science are you using to substantiate these?), NDI notifications, fairy dusting and sub-potent ingredients, and GMP compliance (use of quality logos, pro-endorsements, and superiority of performance claims, for example).
“We are likely to see a sudden burst of Lanham Act-unfair competition lawsuits within our industry,” he said. “So, first and foremost, go back and look at your labels. Ask if you have meaningful amounts of ingredients.”
Fairy dusting of ingredients (adding sub-potent levels) is most likely to produce legal action for high value ingredients, he warned, with the practice less of an issue for commodity ingredients.
“We believe the implications extend to advertising as well as labeling,” said Israelsen.
FDA: No longer the last word
The decision also has implications for the FDA, he said. “The tradition of deferring to FDA’s judgment and expertize with respect to labeling requirements has changed. There is now a separate standard that will apply. This is critical as we look at labels within dietary supplements and food and functional foods, we can find many analogous products that would follow the same kind of issues raised by this Minute Maid-POM case.
“Although you are technically in compliance you can now be sued by your competitor if you can demonstrate several things.
“Previously, the courts have said that the FDA is the arbiter of this, but the POM case suggests that FDA’s decision is no longer the last word,” said Israelsen.
Implications for GMO labeling…
An interesting development revolves around the GMO labeling issues, said Israelsen. The Grocery Manufacturers Association (GMA) has found a silver lining of sorts in the decision, he said. “In a comment to MA, a GMA spokeswoman says the association is ‘encourage by the court’s strong warning that inconsistent state laws and state court rulings threaten to cause ‘disuniformity’ in national food labeling and were expressly preempted by Congress’.
“On page 14 of the 20 page unanimous opinion, Justice Anthony Kennedy writes that the application of the Lanham Act ensure fair competition and, as such, ‘is quite different from the disuniformity that would arise from the multitude of state laws, state regulations, state administrative agency rulings, and state-court decisions that are partially forbidden by the FDCA’s pre-emption provision’.”