On October 4th, the FDA and CDC announced that the agencies have entered into a Memorandum of Understanding, renewing their collaboration to reduce the occurrence of foodborne illness in retail and foodservice establishments. The stated purpose of the partnership is to “help increase the consistency and capacity of retail food protection programs
FTC/FDA Cease and Desist Letters to Companies Touting Diabetes Cures: Is the FTC Testing the Limits of Its Civil Penalty Authority?
As they often have done in the past, the FTC and the FDA issued joint cease and desist letters last week to 10 companies suspected of making unproven health claims – in this instance, claims that dietary supplements treat or cure diabetes. The FTC and the FDA join forces on such letters in order to
Dietary Supplement and Personal Care Products Regulatory Highlights – February 2021
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.
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
Dietary Supplement and Personal Care Products Regulatory Highlights – January 2021
Welcome to our monthly roundup of regulatory and litigation highlights impacting the dietary supplement and personal care products industries.
NAD tackled substantiation for “#1 Dermatologist Recommended” claims in a challenge involving L’Oreal’s CeraVe moisturizer and use of syndicated survey data to support related claims.
Health claim substantiation was front and center in
FDA and FTC Joint Warning Letters Target Amazon Affiliates Making False COVID-19 Claims
Earlier this week, federal regulators continued their efforts to combat the spread of products featuring allegedly false and misleading claims that products can diagnose, treat, cure, or prevent COVID-19. In warning letters issued to CBD Gaze, Alternavita, Musthavemom.com, and Careful Cents LLC, the agencies identify the respective recipients as participants in
Finding Fevers: FDA Relaxes Rules On Temperature-Detecting Cameras
As business people, airport management, and event hosts everywhere try to figure out how they can return to business as usual, many are considering telethermographic device systems. These are cameras that can detect human temperature in comparison to their surroundings to help identify fevers. Reuters reported last week that Amazon implemented thermal cameras at its
Read This Before You Market Around Coronavirus
Until recently, most consumers likely associated anything starting with “Corona” with a sunny beach and a lime wedge.
Not anymore.
The public is rightly concerned about coronavirus and how to avoid catching it. And where the public has questions, marketers will have answers. Here are a couple things to think about before rushing that next