Opinion
No. B284057.
08-15-2018
[Modification of opinion (25 Cal.App.5th 278; ___ Cal.Rptr.3d ___), upon denial of rehearing.]
THE COURT. — IT IS ORDERED that the opinion filed herein on July 16, 2018, be modified as follows:
1. In section A of the FACTUAL AND PROCEDURAL BACKGROUND, on page 6 [25 Cal.App.5th 284, advance report, 1st full par., lines 1-2], the first sentence of the last paragraph, which reads:
Notably, the OEHHA heeded the FDA's advice letters and deferred to the FDA's approach to acrylamide.
Is modified to read as follows:
Notably, the California authorities heeded the FDA's advice letters and deferred to the FDA's approach to acrylamide.
2. In section E of the FACTUAL AND PROCEDURAL BACKGROUND, on page 13 [25 Cal.App.5th 288, advance report, fn. 5, lines 1-4], the first two sentences of footnote 5, which read:
Neither party addressed whether a Proposition 65 warning on whole grain cereals would lead to labels on other foods, but this presents a concern. Proposition 65 warnings on foods containing acrylamide above California's nonsignificant risk levels would cause many otherwise healthy foods to appear to consumers to be unhealthful and vice versa.
Are modified to read as follows:
Neither party addressed whether a Proposition 65 warning on whole grain cereals would lead to labels on other otherwise healthful foods, but this presents a concern. Proposition 65 warnings on foods containing acrylamide above California's nonsignificant risk levels would cause many such foods to appear to consumers to be unhealthful and vice versa.
3. In section V of the DISCUSSION, on page 24 [25 Cal.App.5th 296, advance report, 1st full par., lines 4-6], the last sentence on that page, which reads:
Dr. Sowinski characterizes them as "old letters," but California regulators complied with them, so the FDA had no reason to issue further advice letters regarding Proposition 65 warnings for acrylamide.
Is modified to read as follows:
Dr. Sowinski characterizes them as "old letters," but California regulators heeded them, so the FDA had no reason to issue further advice letters regarding Proposition 65 warnings for acrylamide.
4. In section V of the DISCUSSION, on page 24 [25 Cal.App.5th 296, advance report, 1st full par., line 6], at the end of the last sentence on that page:
Insert a new footnote number 9, which will require renumbering of all subsequent footnotes, that reads as follows:
Notably, it is not the FDA's letters that preempt the proposed Proposition 65 acrylamide warnings here, but the numerous federal statutes enacted by Congress to increase Americans' consumption of whole grains, whose policy objectives would be obstructed by such a warning. For this reason, Reid v. Johnson & Johnson (2015) 780 F.3d 952, in which the Ninth Circuit held that a particular FDA letter lacked any preemptive effect, is inapposite. Moreover, Reid merely held the FDA letter at issue lacked the force of law necessary to preempt state law, largely due to its "equivocal language" regarding the FDA's intentions. That letter was "couched in tentative and non-committal terms" and did "not promise that the FDA will not enforce its ... regulation" but instead provided "that the FDA `intends to consider the exercise of enforcement discretion' in certain circumstances." (Id. at p. 965, italics added.) By contrast, the FDA letters here were unequivocal. The 2003 FDA letter stated, "[A] requirement for warning labels on food might deter consumers from eating foods with such labels. Consumers who avoid eating some of these foods, such as breads and cereals, may encounter greater risks because they would have less fiber and other beneficial nutrients in their diets. For these reasons, premature labeling requirements would conflict with FDA's ongoing efforts to provide consumers with effective scientifically based risk communication to prevent disease and promote health." In its 2006
letter, the FDA stated, "California should not require acrylamide warning labels for foods under Proposition 65 before completion of scientific studies adequate to assess the potential risk of acrylamide to consumers and until FDA determines, based on our risk assessment, that risk management measures (beyond our current advice to eat a balanced diet) are needed."
5. In section V of the DISCUSSION, on page 25 [25 Cal.App.5th 296, advance report, 1st full par., line 6], the last sentence of the partial paragraph, which reads:
This shows that the FDA continues to execute on the strategy outlined in its advice letters and has not endorsed California's 0.2 microgram/day standard that would require many foods to be labeled.
Is modified to read as follows:
This shows that the FDA continues to execute on the strategy outlined in its advice letters and has not endorsed California's 0.2 microgram/day standard that would require whole grain cereals to be labeled.
There is no change in the judgment.
Real party in interest's request for judicial notice is granted.
Real party in interest's petition for rehearing is denied.