Trader Joe’s enjoys sweet victory, dismissal of honey labeling case

A putative class action involving allegations related to Trader Joe’s Manuka Honey has been dismissed after a California federal district court granted Trader Joe’s motion to dismiss without leave to amend. The consumers alleged that Trader Joe’s mislabeled and falsely advertised its manuka honey as “pure” when it was allegedly adulterated. In dismissing the complaint, the court concluded that plaintiffs could not plead sufficient facts to support their adulteration theory since their theory involved the bee’s mixing of pollen and not the manufacturer intentionally mixing manuka honey with non-manuka honey. Since the consumers admitted they could not plead enough facts to support their adulteration claims, the court also dismissed the breach of warranty and fraud claims. The product labeling is accurate and, therefore, not misleading. Finally, the state law claims are preempted (Moore v. Trader Joe’s Company, June 24, 2019, Westmore, K.).

Trader Joe’s (manufacturer) markets and sells “Trader Joe’s Manuka Honey.” Plaintiffs (consumers) allege that two representations contributed to their alleged injuries. On the front label, the product states “100% New Zealand Manuka Honey” or “New Zealand Manuka Honey. The ingredient statement lists “manuka honey” as the only ingredient. The consumers allege that the product testing they purchased showed that approximately 57 and 62 percent of the pollen in the tested honey was from the manuka flower; the remaining pollen was from other floral sources. The consumers allege that Trader Joe’s sales and marketing violate consumer protection laws because the honey is mislabeled and falsely advertised as pure manuka honey, but it should be labeled as “Manuka-based.” Trader Joe’s filed a motion to dismiss.

Insufficient facts to support adulteration

The court granted the manufacturer’s motion to dismiss without leave to amend because the consumers confirmed they could not plead sufficient facts to support the adulteration theory.

The consumers’ theory of adulteration is that bees visit different floral sources and return to the hive, which lowers the manuka pollen count; their theory was not that the manufacturer purposefully mixed manuka honey with non-manuka honey. The FDA’s industry guidance on honey labeling, which was referenced by both parties, only discusses adulteration with non-honey sources and not mixing high-value honey with less expensive honey. Further, the guidance does not address whether the mixing would constitute adulteration.

The court concluded that to constitute adulteration, the manufacturer would have to purposefully mix manuka and non-manuka honey. In this case, all the involved honey is technically manuka honey with varying pollen counts—there is no adulteration in violation of the FDC Act.

Since the consumers could not demonstrate adulteration, the court also dismissed the breach of warranty claim and fraud claim. The fraud claim is not actionable because it is predicated on adulteration whereby the manufacturer (not bees) purposefully mixed manuka and non-manuka honey; the consumers have no facts to support that theory.

Product labeling is accurate and not misleading

The court concluded that product label is accurate because the consumers cannot allege adulteration, honey is a single ingredient food, and the chief floral source is manuka. Furthermore, since the label is accurate, a reasonable consumer cannot find it misleading. Trader Joe’s product is accurately labeled as 100 percent manuka honey.

Draft guidance seeks to make drug labels clear, concise, more consistent

In an effort to assist applicants in writing the Indications and Usage section of labeling for human prescription drug and biological products, the FDA issued a new draft guidance. The FDA’s intent is to make information in prescription drug labeling easier for health care practitioners to access, read, and use. The goal of the guidance is to help ensure that the labeling is clear, concise, useful, and informative and, to the extent possible, consistent in content and format within and across drug and therapeutic classes (Notice, 83 FR 31759, July 9, 2018).

Indications

The Indications and Usage section should clearly communicate the scope of the approved indication, including the population to which the determination of safety and effectiveness is applicable. The guidance includes information on how and when evidence may support approval of an indication that is broader or narrower in scope than the precise population studied.

The indication should begin “Drug X is indicated” and be followed by the disease, condition, or manifestation of the cease or condition being treated, prevented, mitigated, cured, or diagnosed, and when applicable other information necessary to describe the approved indication. The other information may include selected patient subgroups or disease sub populations for whom the drug is approved, adjunctive or concomitant therapy or therapeutic modalities to use before initiation drug therapy, or specific tests needed to select patients in whom to use the drug.

Limitations of use

Limitations of use should be presented separately from the indication and should only be included when the awareness of such information is important for practitioners to ensure the safe and effective use of the drug. Limitations of Use are appropriate for drugs for which there is reasonable concern or uncertainty about effectiveness or safety in a certain clinical situation, drugs approved without evidence of benefits known to occur with other drugs in the same class, or drugs with dose, duration, or long-term use considerations.

Language

Certain products have statutory or regulatory required or recommended language for the Indications and Usage section. The guidance includes preferred wording and wording to generally avoid. For example, the guidance explains why it is better to use the phrase “reduce the risk” or “reduce incidence of” rather than using “prevent” in the indication. It also discusses when the terms “only” and “also indicated” should be avoided. Finally, product should be identified by the proprietary name or trade name if it has one, and other information such as the dosage form, and route of administration should not be included in the indication.

 

FTC nails opiate withdrawal supplement company for misleading statements

Catlin Enterprises, Inc. (Catlin) is now barred from making scientifically unsubstantiated claims that their opiate withdrawal treatment alleviates withdrawal symptoms and increases the chances of overcoming opiate dependency. A Texas district court ordered the permanent injunction following the Federal Trade Commission’s (FTC) complaint against Catlin.

Complaint and order

The FTC alleged that Catlin falsely advertised its products Withdrawal Ease and Recovery Ease and participated in deceptive acts throughout the process of labeling, advertising, distribution, and sale of the products. According to Catlin’s statements, Withdrawal Ease significantly alleviates opiate withdrawal symptoms and significantly increases the likelihood of overcoming dependency, while Recovery Ease significantly alleviates post-acute withdrawal symptoms.

The injunction prevent Catalin and its officers, agents, employees, and other people actively participating in the company from engaging in any steps of the process of making and selling any dietary product intended to provide withdrawal assistance or other health benefits and represented as having such benefits unless such statements are not misleading. Any representation of benefits much be based on reliable scientific evidence, obtained from human clinical testing of the product or an equivalent product. The testing must be conducted by qualified researchers and be randomized, double-blind, and placebo controlled.

A $6.6 million judgment was entered and suspended premised upon the accuracy of sworn financial statements. Catalin must provide the FTC with customer information to allow the FTC to “administer consumer redress,” when requested, then destroy this information when instructed to do so by the FTC.

FDA considers establishing a new ‘Office of Patient Affairs’

The FDA announced that it is establishing a public docket to solicit public input on ongoing efforts to enhance mechanisms for patient engagement at the agency. In addition, to achieve a more transparent, accessible, and robust experience for patient communities, the FDA is considering establishing a new Office of Patient Affairs.

On November 4, 2014, the FDA established a docket (FDA-2014-N-1698) for the public to submit information related to the FDA’s implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) (P.L. 112-144), Patient Participation in Medical Product Discussions under FDASIA section 1137.

Based on the comments received, the FDA identified objectives for its patient engagement activities. First, to develop a nuanced understanding of the patient experience of disease by: (1) gathering patient perspective on what is clinically meaningful; (2) assessing attitudes towards benefit-risk and tolerance of uncertainty; and (3) enhancing the science of eliciting and integrating patient input.

Second, to support patients and their advocates in understanding regulatory processes and navigating the FDA by: (1) communicating relevant FDA positions, procedures, and activities; (2) connecting patients and their advocates with the appropriate resources; and (3) resolving discrete challenges and needs.

To achieve these objectives, the FDA is considering establishing a central “Office of Patient Affairs.” The responsibilities of this central office would include:

  • offering a single, central entry point to the FDA for the patient community;
  • providing triage and navigation services for inbound inquiries from patient stakeholders;
  • hosting and maintaining robust data management systems that would incorporate and formalize knowledge shared with the FDA by patient stakeholders and the FDA’s relationships with patient communities; and
  • developing a scalable and forward-looking platform for communicating with patient stakeholders, particularly online channels.

The Office of Patient Affairs would be directly accountable to the medical product Centers. A regular evaluation of this central office and of FDA’s overall patient engagement efforts are also proposed.