Legislative Developments

Welcome to our monthly roundup of regulatory and litigation highlights impacting the dietary supplement and personal care products industries.  Sit back, relax, and enjoy the read.  February was a short month, with a lot going on.

NAD

Health claim substantiation was front and center before NAD in a monitoring case involving Pendulum Therapeutics and a “medical probiotic” product featuring claims such as “The only medical probiotic clinically shown to lower A1C & blood glucose spikes for the dietary management of T2D*” (*Consult your physician as part of your total diabetes management plan.  Results may vary from person to person.”)

The advertiser submitted a 12-week multi-center, randomized, double-blind, placebo-controlled study (the “Perraudeau Study”) to assess Pendulum Glucose Control’s safety and effectiveness in improving glycemic control in Type 2 diabetics and, ultimately, their dietary management of the disease – specifically, the role of certain probiotic strains found in prior research to be associated with the promotion of a healthy gut microbiome through the production of short-chain fatty acids (SCFAs).

The advertiser also provided clinical studies and research articles demonstrating the roles of A1C, fasting glucose and postprandial glucose levels in managing Type 2 diabetes. The advertiser also referred to the FDA’s Guidance document (Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention) to demonstrate what level of reduction in HbA1c was clinically meaningful.

While NAD expressed some concerns about the evidence, ultimately, NAD determined that the Perraudeau Study was a good fit for the challenged claim “The only medical probiotic clinically shown to lower A1C & blood glucose spikes for the dietary management of T2D*” (*Consult your physician as part of your total diabetes management plan. Results may vary from person to person.”) but recommended the following modifications: (1) limiting the claim to individuals who are taking metformin; (2) modifying the claim to clarify that the product can be used as part of the dietary management of type 2 diabetes; and (3) removing the references to percent reductions in blood glucose spikes in the absence of evidence in the record demonstrating that the reductions were clinically relevant.

This decision is a helpful discussion of the competent and reliable scientific evidence standard.  Anyone seeking to understand health claims substantiation better should check it out.
Continue Reading Dietary Supplement and Personal Care Products Regulatory Highlights – February 2021

Ad Law Access Blog - the State of Maryland enacted legislation imposing the Digital Advertising Gross Revenues TaxOn February 12, 2021, the General Assembly of the State of Maryland enacted legislation imposing the Digital Advertising Gross Revenues Tax, overriding a prior veto of the legislation by Maryland Governor Larry Hogan. The Act imposes a tax, at rates of up to 10%, on gross revenues “derived from digital advertising services in the state.” 

Renewal ButtonIn recent years, a number of states have passed laws governing automatic renewals. New York is the latest state to jump on this trend. Its current law only applies to certain contracts “for service, maintenance, or repair to or for any real or personal property.” The new law, which will become effective in February 2021,

Continuing its intense focus on internet platforms’ role in political debate and the liability protections they receive under the Communications Decency Act (CDA), 47 U.S.C. § 230, the Trump Administration this week submitted a legislative proposal that would substantially limit platforms’ Section 230 immunity. The Administration’s legislative proposal joins several other bills that take aim

Senate Commerce Committee Republicans Include 13(b) Fix in New Privacy LegislationLate last week, Senate Commerce Committee Chairman Roger Wicker (R-MS), along with Senators John Thune (R-SD), Deb Fischer (R-NE), and Marsha Blackburn (R-TN), introduced S. 4626, the Setting an American Framework to Ensure Data Access, Transparency, and Accountability (SAFE DATA) Act. The comprehensive privacy bill was years in the making and follows a discussion draft

Kelley Drye Advertising Law Summer Webinar Series This Wednesday, July 22
Selling Online: How to Avoid Flattening the Curve of an Uptick in Website Traffic
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COVID-19 has increased the already dizzying amount of online sales, making the applicable marketing requirements increasingly important. These rules affect not just how companies advertise and promote products and services online, but also how they

Democrats Release Their Own COVID-19 Privacy LegislationFollowing the Republican-sponsored COVID-19 Consumer Data Protection Act of 2019, Democratic legislators recently introduced the Public Health Emergency Privacy Act. Senators Richard Blumenthal and Mark Warner of Connecticut and Virginia, respectively, and a group of Democratic Representatives, including Jan Schakowsky of Illinois and Anna Eshoo of California, introduced the measure.

While both measures

In light of concerns associated with attempts to use personal data to track the spread of COVID-19, a group of Republican Senators, led by Mississippi Senator Roger Wicker, introduced the COVID-19 Consumer Data Protection Act of 2020 today.

The bill imposes specific requirements on entities seeking to process precise geolocation data, proximity data, persistent

Bill MacLeod and other panelists representing antitrust and consumer protection bureaus from across the country discussed recent enforcement activities and the ongoing missions of state enforcement agencies during the American Bar Association’s Antitrust Section Virtual Spring Meeting.

Watch the replay here.

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