We will not be posting today in commemoration of Labor Day. We’ll be back to our regular schedule tomorrow, Tuesday, September 2nd.
Zarbee’s Naturals, the manufacturer of numerous over-the-counter remedies aimed at relieving coughs, colds, allergies and sleeplessness was issued a warning letter by the Food and Drug Administration for making therapeutic claims which would cause their products to be classified as drugs under the federal Food, Drug, and Cosmetic Act. Zarbee’s products, described by the company as “natural relief,” have not been approved by the FDA
The FDA identified the following products in its warning letter:
- Zarbee’s Naturals Children’s Cough Syrup+Mucus Relief
- Zarbee’s Naturals Children’s Cough Syrup
- Zarbee’s Naturals Children’s Cough Syrup Nighttime
- Zarbee’s Naturals Seasonal Relief
- Zarbee’s Naturals Sleep
- Zarbee’s Naturals Children’s Sleep
The FDA noted that claims made by the company indicate the products are intended for use as drugs, such as the statement that Zarbee’s Naturals Seasonal Relief 10 Count is “clinically supported to work fast and offer congestion relief so you can breathe better in every season.” The FDA also took issue with Twitter testimonials, both in the form of original tweets from Zarbees and “retweets” or sharing tweets of others endorsing the products.
The FDA warning letter also stated that Zarbee’s had numerous posts indicating their products were intended for use as drugs, and that the company “liked” and responded to Facebook testimonials by consumers recommending products for use as drugs. The agency also warned that three of Zarbee’s products are considered misbranded.
“Furthermore, your products “Zarbee’s Naturals Children’s Cough Syrup+Mucus Relief,” “Zarbee’s Naturals Children’s Cough Syrup Nighttime,” and “Zarbee’s Naturals Children’s Sleep” are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.”
Noting that the warning letter was not meant as an all-inclusive list of deficiencies, the company was given 15 days to respond to the FDA. The warning letter was dated June 27, 2014. Zarbee’s spokesperson did not respond to Wolters Kluwer’s request for comment.
We will return Monday, July 7 with our regular posting schedule.
The Supreme Court issued a 5-4 ruling in Burwell v Hobby Lobby, holding that closely held corporations cannot be required to provide contraception coverage. The court was asked to determine if the Religious Freedom Restoration Act (RFRA) (P.L. 103-141) allows a for-profit corporation to deny its employees the health coverage of contraceptives to which the employees are otherwise entitled by federal law, based on the religious objection of the corporation’s owners. Justice Alito issued the majority opinion, joined by the Chief Justice and Justices Scalia, Thomas, and Kennedy. Justice Kennedy wrote a concurring opinion. Justice Ginsburg wrote a dissent in which she was joined by Justice Sotomayor; she was also joined in part by Justices Breyer and Kagan, who separately issued a dissent.
In 2012, Hobby Lobby, a national craft store chain, filed suit against then-HHS Secretary Kathleen Sebelius and various federal government entities, alleging that the preventive care services provision of the ACA, which requires Hobby Lobby to cover FDA-approved contraception in its employee health plans, violated its rights. Hobby Lobby objected because it considers some forms of contraception to be abortifacients, such as Ella®, Plan B One-Step®, and intrauterine devices, and subsequently argued that the preventive care services provision violated the RFRA, the Free Exercise Clause of the First Amendment, and the Administrative Procedure Act. At the direction of the Tenth Circuit, the district court granted Hobby Lobby a preliminary injunction barring the federal government from enforcing the preventive services provision of the ACA.
The Solicitor General petitioned the Supreme Court to hear the case, and the petition was granted. At that time the case was consolidated with a Conestoga Wood Specialties Corp v Sebelius (now Conestoga Wood Specialties Corp. v Burwell), which involved a secular for-profit corporation alleging that the mandate violated its shareholders’ Mennonite beliefs. The Third Circuit had upheld the denial of a preliminary injunction in the case.
For a full history of the cases, please click here.
In-depth analysis of this case will be posted later in the week.