25 Years Later: Gottlieb & FDA Seeks to Modernize DSHEA
On the heels of the Food and Drug Administration's (FDA) announcement earlier today that it had issued 12 warning letters and 5 online advisory letters to foreign and domestic companies that are allegedly selling unapproved or misbranded drugs as dietary supplements, FDA Commissioner, Scott Gottlieb, M.D., outlined several new actions and policy changes that the agency will take in the coming months to modernize DSHEA and subsequently improve the safety of dietary supplements.
What Is DSHEA?
If you're new to the dietary supplement industry, you might be wondering "what is DSHEA?" Signed into law by President Bill Clinton, the Dietary Supplement Health and Education Act of 1994 (DSHEA) states that supplements are effectively regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111.
Today's News About DSHEA
As part of today's news about DSHEA, Commissioner Gottlieb recognizes that the dietary supplement industry has significantly grown in size since the passage of DSHEA in 1994. Over the last 25 years, dietary supplement usage among consumers has increased, but the regulatory system under which dietary supplements are regulated has failed to keep pace. Therefore, updating DSHEA is of critical importance.
In order to modernize DSHEA for 2019 and beyond, Commissioner Gottlieb acknowledged that the FDA will consult with both the public and the dietary supplement industry as they approach the prospect of making amendments to DSHEA to serve today's consumer and industry.
"Today's actions are part of the FDA's larger effort to address the booming growth of the dietary supplement industry through the implementation of modern regulatory initiatives that will enable the agency to preserve the balanced vision of the Dietary Supplement Health and Education Act (DSHEA), enacted by Congress 25 years ago."
Here are 6 areas the FDA will seek to address as part of its mission to modernize DSHEA:
- FDA will focus on areas of unlawful claims. They specifically cite Alzheimer's, cancer, and opioid addiction treatments.
- FDA is also establishing a dietary supplement working group within itself to look at organizational structures, process, procedures, and practices to look for opportunities to modernize the oversight of dietary supplements.
- FDA will also develop a new rapid response tool to alert the public about products that violate DSHEA.
- FDA will also be offering ideas about updating its NDI compliance policy.
- FDA will hold a public meeting this spring to receive public comments on a range of issues, which will include some form of dietary supplement exclusivity and to discuss the scope of permitted dietary ingredients.
- Lastly, the FDA has established a Botanical Safety Consortium to evaluate state-of-the-art tools, which are alternatives to animal testing, to promote safety and product effectiveness.
UNPA's Response to Commissioner Gottlieb's DSHEA Statement
In an email to its members early this afternoon, United Natural Products Alliance (UNPA) President, Loren Israelsen, expressed his eagerness to work with Dr. Gottlieb and the FDA on this project.
"We note that this important announcement falls on the 25th anniversary of DSHEA. We recognize that the world has changed. We will work closely with the FDA on each of the stated objectives and the new ideas they propose, and to participate actively in the dietary supplement working group, once that becomes more public, as well as the Botanical Safety Consortium."
Israelsen closed his email by stating that his organization will be in contact with the FDA to open a robust line of communication.
NutraScience Labs' Viewpoint
NutraScience Labs supports the FDA's vision for modernizing DSHEA and we look forward to both the FDA and UNPA working collaboratively over the next few months.
In the meantime, dietary supplement business owners must continue to educate themselves on what claims can and cannot be made on product labels to stay out of the FDA's crosshairs and to avoid costly dietary supplement packaging oversights that have the potential to cripple your business.
Have a question about what we've covered? Leave it in the comments section below or call (855) 492-7388 to speak with one of our knowledgeable and friendly staff members. We'll continue to publish the latest news about DSHEA as we receive it.