BakerHostetler FDA and Pharmacy Weekly Digest - February 26, 2019

Alerts / February 26, 2019
Food/Dietary Supplements

FDA Notes Increased Concerns About Use of Kratom – As the number of reports of poisonings related to the use of kratom increases, Commissioner Gottlieb tweeted, “Kratom is an opioid. #FDA continues to be deeply concerned that its widespread recreational use is contributing to the opioid addiction crisis. People are abusing kratom and, in some cases, are unaware that they’re using an opioid with addictive qualities.”

Food Industry Issues a Number of Recalls – Recent food recalls include salsa seasoning mix and dark chocolate cherries for an undeclared milk allergen, several cereals due to undeclared gluten, and certain smoked salmon products for potential contamination with Clostridium botulinum.


FDA Responds to Question About Generic Drug Quality – The FDA issued a statement responding to assertions “that certain generic drugs are of a lesser quality than brand drugs.” FDA indicated that it is taking steps to maintain the quality and efficacy of generic drug products, including reiterating that generics are as safe and effective as branded products and outlining its robust inspection regime, especially in China and India.

FDA Announces Proposed Rule for Sunscreens – The FDA issued a proposed rule that updates the requirements for many sunscreen products marketed in the U.S. The announcement states, “[T]he proposal addresses sunscreen active ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information.”

FDA Warns Consumers About Plasma Infusions – FDA Commissioner Gottlieb released a statement warning consumers about receiving “infusions of plasma from young donors to purportedly treat the effects of a variety of conditions.” Alleged treatments include Parkinson’s, MS, Alzheimer’s and PTSD. The Commissioner stated, “There is no proven clinical benefit of infusion of plasma from young donors to cure, mitigate, treat, or prevent these conditions, and there are risks associated with the use of any plasma product.”

FDA Issues Guidance on Food-Drug Integrations – The FDA released a draft guidance titled “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations,” which offers recommendations to drug sponsors that plan to conduct food-effect studies as part of the drug application process.

Medical Devices

FDA Hopes to Bolster Development of Innovative Devices – Commissioner Gottlieb released a statement focused on FDA’s efforts to increase development of innovative devices, with a particular interest in novel brain implants to combat paralysis. This announcement is coupled with a draft guidance titled “Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations.”

FDA Releases 510(k) Guidance – The FDA published a final guidance titled “Refuse to Accept Policy for 510(k)s” outlining FDA’s procedures for determining whether a 510(k) submission meets the minimum requirements for acceptance prior to substantive review.

FDA Issues Premarket Approval Application Guidance – The FDA released a final guidance titled “Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)” outlining the preclinical and clinical aspects of the products that must be included in the PMA during the filing process.


FDA Releases Nicotine Replacement Guidance – The FDA announced new steps to aid in the development of innovative nicotine replacement therapies aimed at helping consumers quit smoking cigarettes. The agency stated, “Novel products with different characteristics or routes of nicotine delivery have the potential to offer additional opportunities for health-concerned smokers interested in quitting.” Coupled with its announcement, FDA issued a draft guidance titled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products.”


FDA Issues Warning Letters to Two Compounding Facilities – The FDA recently issued a warning letter to a compounding pharmacy, alleging that the pharmacy failed to meet the requirements under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA). The letter states that the facility violated the FDCA by compounding products that were “not the subject of an applicable USP or NF monograph, are not components of an FDA-approved human drug, and do not appear on the 503A bulks list.” The FDA also issued a warning letter to a facility previously registered as an outsourcing facility under Section 503B of the FDCA, although at the time of the letter the facility was no longer registered with the FDA. One of the violations mentioned in the letter related to the facility’s product list. Specifically, the FDA alleged that the facility compounded products that appeared on neither the 503B bulks list nor the drug shortage list.

FDA to Hold Meeting on Compounding – The FDA will hold a public meeting entitled “Drugs Compounded for Office Stock by Outsourcing Facilities” on May 29, 2019. The meeting will “provide health care professionals, outsourcing facilities, and other stakeholders with an opportunity to discuss access to office stock from outsourcing facilities considering the policies proposed in the revised draft guidance Current Good Manufacturing Practice Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” All requests to make oral presentations must be received by March 1, 2019.

Authorship Credit: Lindsay P. Holmes

Baker & Hostetler LLP publications are intended to inform our clients and other friends of the firm about current legal developments of general interest. They should not be construed as legal advice, and readers should not act upon the information contained in these publications without professional counsel. The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Before you decide, ask us to send you written information about our qualifications and experience.