Washington, D.C.—Commissioner Scott Gottlieb’s departure doesn’t seem to be slowing the FDA down any, if the spate of industry-affecting actions taken on the 19th means anything.
The FDA posted a warning letter to Nutra Pharma Corp. for illegally marketing unapproved products with claims about their ability to treat addiction and chronic pain, according to one press release. Dr. Gottlieb said in the release: “Today, we posted a warning letter to a company preying on patients who may be seeking alternative treatments for chronic pain, cancers, arthritis, and authoimmune and neurological disorders. Health fraud scams like these are inexcusable.”
The products in question include Nyloxin Oral Spray, Nyloxin Topical Roll-on, and Regular Strength Sample Drugs. The release says “These products have not been demonstrated to be safe or effective and may keep some patients from seeking appropriate, FDA-approved therapies.” More on that can be found here.
The FDA will hold a public meeting to discuss the draft guidance for compliance and implementation of the “Mitigation Strategies to Protect Food Against Intentional Adulteration” rule, according to another press release. It will be held on April 17th, 2019, from 8:30 to 2:00.
The press release says that it will discuss topics including the components of the food defense plan, how to conduct vulnerability assessments, and education, training, and experience. The meeting will include a short demo of the FDA’s Food Defense Plan Builder, version 2.0, which will be released later this year. More, including registration information, can be found here.
Last, but certainly not least, the FDA announced a public meeting to discuss responsible innovation in dietary supplements. It will be held on May 16th, 2019, from 8:30-4:00. More specifics, including information regarding registration, will be made available in April, through a Federal Register Notice and on the FDA public meetings website. And, of course, WholeFoods will post that information as soon as it becomes available to us.
According to memos sent to members of the United Natural Products Alliance (UNPA), UNPA will be very active in both meetings, although no strategy has yet been formulated: There are still too few details. Loren Israelsen, president of UNPA, noted in one memo that there will likely be various terms used to describe the initiative towards innovation in dietary supplements; UNPA, however, will refer to it as “DSHEA 2.0.”
UNPA will form an UNPA DSHEA 2.0 Working Group, where, the memo says, “we will invite interested parties to participate in development of UNPA public views with respect to the status of DSHEA, FDA’s initiative to seek amendments, and to develop a comprehensive internal discussion to lay out these issues, debate the pros and cons, and develop strategies to coordinate our views with those of our peer associations and other interested stakeholders.”