GAO Report Urges FDA to Improve GRAS Oversight
As we have discussed in recent postings (here and here), issues regarding the certification of food ingredients as generally recognized as safe (“GRAS”) by the Food and Drug Administration (the “FDA”) have been a hot topic in industry circles. Now, the Government Accountability Office (the “GAO”) has released a report encouraging the FDA to improve its oversight of GRAS food ingredients. Our colleagues from Hyman, Phelps & McNamara’s FDA Law Blog released an excellent post on this subject, so we will discuss the general findings and recommendations of the report here.
The GAO report includes findings that (1) the FDA’s oversight process does not help ensure the safety of all new GRAS determinations, (2) the FDA is not systematically ensuring the continued safety of current GRAS substances, and (3) the FDA’s regulatory approach allows engineered nanomaterials to enter the food supply without its knowledge. The report contains six specific recommendations for FDA action, encouraging the FDA to develop a strategy to:
- require any company that conducts a GRAS determination to provide the FDA with basic information about that determination;
- minimize the potential for conflicts of interest in companies’ GRAS determinations;
- monitor the appropriateness of companies’ GRAS determinations through random audits or some other means;
- finalize the rule that governs the voluntary notification program;
- conduct reconsiderations of the safety of GRAS substances in a more systematic manner; and
- help ensure the safety of engineered nanomaterials that companies market as GRAS substances without its knowledge.
Further, the report contains a general directive that if the FDA determines it does not have the authority to implement one or more of these recommendations, the agency should seek the authority from Congress. In its response to the report, the FDA, while not indicating any definitive posture on the GAO’s recommendations, was generally receptive to the findings and recommendations of the GAO. Given the prominence of the issue of GRAS certification as it pertains to a number of food and beverage products in the marketplace, we will continue to closely monitor this subject.
Hurdles Faced By Plaintiffs In Class Action Lawsuit for Sale and Marketing of Cold and Flu Medications Containing Vitamin C
By Guest Blogger Tyler Anderson
On November 2, we blogged about the FDA warning letter issued to Procter and Gamble for its unlawful marketing of Vicks cold and flu medications containing Vitamin C. On November 4, 2009, a putative class action lawsuit was filed against Procter and Gamble in the U.S. District Court for the Southern District of Ohio (Sixth Circuit) alleging Procter and Gamble violated federal and state consumer protection laws through false and misleading advertising practices regarding the two Vicks products mentioned in the FDA warning letter.
Regardless of the merits of their case, the plaintiffs in this action may have a hard time obtaining their desired relief. In Count 1 of the complaint, the plaintiffs allege Proctor and Gamble violated the consumer protection laws of 43 separate states. The Seventh Circuit’s holding in its Bridgestone/Firestone decision (J. Easterbrook) and its progeny, suggests that under FRCP 23(b)(3), such a class action is unmanageable. Courts point to the impracticability of one court applying the divergent laws of differing jurisdictions in circumstances such as those at bar.
“Plausibility” pleading standards (see recent discussion of Wright v. General Mills) present additional hurdles. Applying Twombly as the court did in the Wright case, to survive a motion to dismiss the plaintiffs would need to make plausible, non-conclusory allegations that the plaintiffs purchased the Vicks products because they contained Vitamin C and the cost of the product with the Vitamin C was greater than it would have been without. No such allegations exist here, so applying the holdings of Twombly and Wright to this claim indicates that it may be subject to dismissal.
“Reliance” may be yet another avenue to dismiss the action (at least in part). Many state consumer fraud statutes require reliance. This means that the plaintiffs would be required to show that each plaintiff in the action bought the product in reliance on the purported fraudulent statement. Because purchasing decisions are individual decisions, proving reliance on a class-wide basis would be an individual inquiry that would predominate over issues of fact common to the class, which would negate class treatment.
Marketing Missive: FDA Issues Warning Letter to Procter and Gamble for Unlawfully Marketing Cold and Flu Medications Containing Vitamin C
By Guest Blogger Tyler Anderson
On October 29, 2009, the FDA issued a warning letter to Procter and Gamble notifying the company that its “Vicks DayQuil Plus Vitamin C” and “Vicks NyQuil Plus Vitamin C” are illegally marketed combinations of drug ingredients and a dietary ingredient. Both of the over-the-counter (OTC) medicines, which contain Vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA issued the warning letter (1) to clarify that these single dosage form combinations of drug ingredients and dietary ingredients cannot legally be marketed because they have not been proven safe and effective, and (2) because the agency has previously determined that there is not sufficient data to show that Vitamin C is safe and effective in preventing or treating the common cold.
Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. The FDA found the two Vicks products did not comply with the applicable FDA monograph, and therefore the products must first be evaluated and approved under the agency’s new drug approval process before they can be legally marketed.
Judge Denies Class Action Status in McDonald's French Fry and Hash Brown Litigation
A lawsuit claiming that McDonald’s deceived the public about ingredients in its french fries and hash browns will not proceed as a class action. A federal judge in Chicago has denied the plaintiffs’ motion for class certification, characterizing the proposed class and subclasses as “too indefinite and overbroad.”
According to the court’s opinion, the potato suppliers who provide McDonald’s with its french fries and hash browns par-fry the potatoes in oil made of 99 percent vegetable oil and one percent natural beef flavor. The beef flavor is partly made from wheat bran and casein (a dairy product). McDonald’s restaurants then fry the potatoes in 100% vegetable oil prior to serving the products to customers. Plaintiffs allege that McDonald’s falsely claimed its french fries and hash browns were gluten, wheat, and dairy-free. They say that they never would have purchased the potato products if they knew that the fries and hash browns were partially fried in oil containing wheat bran and casein. McDonald’s corrected its disclosure in 2006.
The plaintiffs proposed a class consisting of all persons residing in the United States who purchased McDonald’s french fries or hash browns between February 2002 and February 2006 and who, at the time of purchase, had been diagnosed with celiac disease, galactosemia, autism, and/or wheat, gluten, or dairy allergies.
In rejecting class certification, U.S. District Judge Elaine Bucklo noted that none of the plaintiffs has suffered any physical injury from eating the potato products; indeed, she noted that “plaintiffs testified in their depositions that they were quite satisfied with the Potato Products they consumed.” Additionally, Judge Bucklo noted that proving economic damage would be an “evidentiary headache” because the court would be required to review potentially millions of letters proving plaintiffs’ medical diagnoses and the damage to each potential class member would be nominal: between $1.00 and $1.50. Finally, the court ruled a nationwide class action would be unmanageable because state laws at issue in the case vary too much to apply to plaintiffs from across the country.
The case is In re McDonald’s French Fries Litigation, MDL No. 1784.
