Category: Regulatory and Industry Standards

Northern District of California Sours Plaintiff’s Claims against “Vanilla” Soymilk Maker

Share

The Northern District of California recently dismissed a Plaintiff’s claim that the term “vanilla” was misleading on the label of a soymilk product, but left the proverbial door open for the filing of an amended pleading.

In Clark v. Westbrae Natural, Inc., Case No. 20-cv-03221, Plaintiff alleged that Defendant’s use of the word “vanilla” on the label of its organic unsweetened soymilk misrepresented to consumers that the product’s vanilla flavor was derived exclusively from the vanilla bean plant. Gas chromatography‒mass spectrometry analyses showed that the flavor came from a non-vanilla source. Plaintiff alleged he would not have purchased the product had he realized the flavor was not derived from the vanilla bean, and asserted claims under California’s Unfair Competition Law, False Advertising Law, and Consumers Legal Remedies Act.  He argued that the product should be labeled “artificially flavored.”

Continue reading “Northern District of California Sours Plaintiff’s Claims against “Vanilla” Soymilk Maker”

FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval

Share

The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics license applications (BLAs) for biosimilar and interchangeable products, and for other parties interested in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This new guidance aims to further facilitate the development of proposed biosimilar products and proposed interchangeable products.

The BPCI Act created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. This newly released draft guidance is the third FDA question-and-answer guidance on the BPCI Act, with the previous two released in December 2018: Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry and New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).

Continue reading “FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval”

Preemption of Structure/Function Claims

Share

Seen frequently on grocery items, and especially on dietary supplements, structure/function claims describe the role of a nutrient or ingredient in the structure or function of the human body. Examples include “Calcium builds strong bones,” “St. John’s Wort supports mood,” and “Vitamin E supports the immune system.”

The FDA defines and regulates structure/function claims, and FDA requirements generally preempt state-law requirements that are “not identical.” 21 U.S.C. § 343-1(a)(5). So, does compliance with FDA regulations for structure/function claims shield food and supplement manufacturers from lawsuits claiming their structure/function claims are false and misleading?

Continue reading “Preemption of Structure/Function Claims”

FDA Issues Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic

Share

As the COVID-19 pandemic continues to alter ways of life across the globe, clinical trials must be adapted for participant safety while maintaining accuracy in the midst of the ongoing crisis. In September 2020, the U.S. Food and Drug Administration (FDA) updated its “Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency,” providing specific recommendations for ongoing or upcoming clinic trial activities.

Continue reading “FDA Issues Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic”

FDA Gives Guidance on Reporting Medical Device Shortages

Share

Last week, FDA released guidance for life sciences manufacturers that produce medical devices and components “critical to public health,” including materials that support or sustain life, or are used in emergency care or surgery.  If there is an anticipated (or actual) disruption that may result in a shortage based on increased demand or supply-side interruption, the FDA must be notified no later than seven calendar days from the onset.  The requirement to notify the Agency applies to a broad range of devices and equipment, and lasts for the duration of the COVID-19 emergency.

The FDA’s guidance on this topic arises out of the March 27, 2020, CARES Act amendments to the Food, Drug and Cosmetic Act.  Those updates, codified at 21 U.S.C. § 356j, mirror similar provisions for prescription drug shortages implemented in December 2016.  While the statutory provisions contemplate that a device manufacturer would provide notice to the FDA of an anticipated shortage or interruption at least six months in advance, or “as soon as is practicable,” the recent guidance recognizes that this may not be possible under current market conditions.

Continue reading “FDA Gives Guidance on Reporting Medical Device Shortages”

Biometric Data Privacy: Why Illinois Regulation Is Relevant to Manufacturers Nationwide

Share

Our federal system and the often dysfunctional nature of Congress can be vexing for cutting-edge manufacturers. Emerging technologies are rarely addressed at the federal level, leaving states to pass piecemeal regulations that can frustrate even the most attentive compliance officers. If you’re bringing a product to market nationwide, you need to be aware of which states have the most stringent regulations. When it comes to biometrics, Illinois tops that list.

The Illinois Biometric Information Protection Act (BIPA) generally is considered the most stringent in the United States, and lawmakers in Florida and New York City are currently working on passing similar measures. So just what is the current state of biometric data privacy in Illinois? The answer lies in three rather unexpected topics: roller coasters, robot dogs, and pizza.

Continue reading “Biometric Data Privacy: Why Illinois Regulation Is Relevant to Manufacturers Nationwide”