NYSDA Publications

FDA Issues Regulatory Update

The United States Food and Drug Administration (FDA) has issued its weekly regulatory update for stakeholders.  You can read the FDA regulatory update for stakeholders below.

FDA Stakeholder Update Banner

April 28, 2023

Dear Colleague,

While the FDA continues to focus on protecting the public’s health, using science to guide our decisions, and facilitating access to critical medical products, we also recognize the work of our public health partners. As public health advocates, we know that your work to better our country is invaluable. Your partnership, knowledge and engagement in the public health space are appreciated.



Consumer Updates

Apetamin — An Illegally Imported Weight Gain, Figure Augmentation Product


The FDA reviewed several incidents of serious adverse events associated with the use of Apetamin, which is being marketed illegally for weight gain and figure augmentation.

Apetamin is not an FDA-approved product. It is manufactured overseas and illegally imported into the U.S. Although the FDA restricted importation of Apetamin, the product continues to find its way into the U.S. market, often via online marketing and in some retail stores. Apetamin is heavily promoted and sold through social media, targeting people seeking to gain weight and achieve a certain physique.

Apetamin contains cyproheptadine, a potent antihistamine that requires a physician’s prescription in the U.S.


FDA Warns of Use of Selective Androgen Receptor Modulators (SARMs) Among Teens, Young Adults


The FDA is warning consumers that the agency continues to receive adverse event reports related to selective androgen receptor modulators, commonly called SARMs. Social media posts by influencers and sellers of SARMs contribute to the availability and promotion of these dangerous products.

Targeting teenagers and young adults, videos on social media platforms tout SARMs as a quick or easy way to improve physical appearance, gain muscle mass, or increase athletic performance.

SARMs, which are chemical substances that mimic the effects of testosterone and anabolic steroids, are not FDA approved. Online vendors and social media influencers are using social media to make SARMs seem safe and effective.



Ticks and Lyme Disease: Symptoms, Treatment, and Prevention

Lyme.pngTick-borne diseases, such as Lyme disease, are on the rise in people and dogs. Reported cases in people in the U.S. increased from about 12,000 annually in 1995 to approximately 35,000 in 2019, according to the Centers for Disease Control and Prevention. However, not all diagnosed cases are reported and the CDC believes the true number of human infections is likely closer to 476,000 per year.

The FDA regulates products that are used to help prevent, diagnose, and treat this complex disease.

Who Gets Lyme Disease, What Time of Year?

Lyme disease is a bacterial infection most commonly transmitted via the bite of infected ticks, which attach to any part of the body.



Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products

The FDA is announcing the availability of a final guidance for industry entitled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products; Guidance for Industry.” The document provides guidance to assist sponsors in the clinical development of nicotine replacement therapy (NRT) drug products, including but not limited to those intended for smoking cessation and related chronic indications.


The FDA is announcing the availability of a final guidance for industry entitled “S12 Nonclinical Biodistribution Considerations for Gene Therapy Products.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The final guidance provides harmonized recommendations for the conduct and overall design of nonclinical biodistribution (BD) studies for gene therapy (GT) products.

View all Official FDA Guidance Documents and other Regulatory Guidance
You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

Webinars and Virtual Workshops

Conversations on Cancer: “Cancer Misinformation: Truth or Consequences”

May 4, 2023; 2:00 - 3:30 PM ET

OCE Conversations on Cancer will bring together experts in medical journalism and the oncology field to give examples of cancer misinformation on social media platforms and in mainstream news outlets. We will discuss how to identify misinformation online, and be able to recognize when information is false or misleading. We’ll discuss strategies for moving forward, barriers and facilitators to social media use for patient and community education.


FDA/CRCG Drug-Device Combination Products 101: Identifying, Developing, and Evaluating Drug-Device Combination Products

May 10, 2023; 8:30 AM - 6:00 PM ET

The purpose of this training is to describe FDA’s regulatory expectations and practices for pre-ANDA assessment and ANDA review of generic drug-device combination products, especially those with complex device constituent parts.


Considerations for Buprenorphine Initiation and Maintenance Care

May 10 - 11, 2023

Day 1: ET
Day 2: ET

The FDA, in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Reagan-Udall Foundation for the FDA, will hold a two-day virtual public meeting.

This virtual public meeting will explore real-world experiences and scientific evidence for buprenorphine initiation strategies as well as medication dosing and management during continued treatment across different care settings.

Register Here


Creating a Roadmap to Quantitative Systems Pharmacology-Informed Rare Disease Drug Development

May 11, 2023; 10:00 AM - 5:00 PM ET

The purpose of this workshop is to discuss the potential utility of quantitative systems pharmacology (QSP) in rare disease drug development and brainstorm the potential path to address the challenges and facilitate its use.

There are approximately 7,000 rare diseases. There is a public heath need to develop safe and efficacious drugs to treat these conditions. However, there are many challenges in developing drugs for rare diseases, including the small number of patients available for clinical trials to optimize the dosing regimen and demonstrate safety and efficacy of the drug, inter-individual variation in the course of disease, and a lack of well-characterized biomarkers to inform drug effects.


View Upcoming FDA Meetings, Conferences and Workshops
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

About Us

The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations.