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9th Cir: No Pre-emption in Suit Over Benecol Health Claims

By Casey C. Sullivan, Esq. on March 16, 2015 | Last updated on March 21, 2019

The Ninth Circuit has reinstated a proposed class action against Johnson & Johnson and McNeil Nutritionals over allegedly misleading health claims and the trans fat content of their Benecol butter substitute, once hailed as one of the first foods "designed to act like medicine."

Plaintiff Robert Reid contended that Benecol was improperly being marketed as a health food, particularly challenging the product label's statements that it contained "no trans fats" and touting the cholesterol-reducing powers of plant stanol esters. The unanimous decision overturned a district court's ruling that such claims were pre-empted.

Benecol, whose name is meant to evoke "good cholesterol," claims to contain no trans fats and reduce cholesterol through the inclusion of plant stanol esters. Much to Reid's chagrin, a serving of Benecol included up to half a gram of trans fats.

FDA Regulations Did Not Pre-empt False Advertising Claims

Johnson & Johnson had argued that Reid's unfair competition and false advertising claims, brought under California law, were pre-empted by the FDA's regulations governing labeling and nutritional claims. The Ninth Circuit rejected this defense, finding no express or conflict preemption. While the Nutritional Labeling and Education Act required uniform food labeling requirements, it clearly states that it does not pre-empt state laws which do not impose inconsistent labeling requirements. Thus, California's consumer protection laws were not pre-empted.

Further, while statements such as "fat free" are permitted for products with under a half a gram of fat per serving, no such permission is given for trans fats. Since the FDA had not regulated statements allowing "no trans fats" for products with small amounts, the court found no conflict pre-emption. Similarly, the few statements the FDA had made about its enforcement intentions and plant stanol esters did not create federal "law" which could preempt state law claims.

The Average Consumer Is Not a Butter Expert

The Ninth Circuit also cautioned against relying too strongly on a consumer's understanding of nutritional labels. The district court had ruled that no reasonable consumer would be misled by the statement of "no trans fat," since the claim was belied by the listing of partially hydrogenated vegetable oil as an ingredient. However, one cannot assume, the Ninth Circuit stated, that the average consumer will know that partially hydrogenated vegetable oil contains trans fat and thus would not rely on the "no trans fat" label. The rational consumer is but a shopper after all, not a nutritionist.

Reid's lawsuit is now free to continue in district court, where his factual claims of false advertising and unfair competition will be put to the test.

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