MAY 20, 2021
CBD drug preclusion issue, FDA warning letters among drivers of DSHEA 2.0 discussion, Mister says
CRN President & CEO Steve Mister shared insights on what's ahead for dietary supplement regulation during a panel discussion at the Food and Drug Law Institute's (FDLI) annual conference this week. The discussion centered around calls to revamp DSHEA and strengthen FDA’s ability to regulate the supplement category.
Mister explained how attention to the regulatory status of CBD could have broader implications for revising DSHEA. Because of a "drug preclusion provision," CBD cannot be marketed as a dietary supplement because it was already authorized for investigation as a new drug. The drug preclusion issue is not a safety issue, Mister emphasized—and not unique to CBD. While HR 841 provides a legislative exception to the provision and allows CBD products to be marketed as dietary supplements, it doesn’t fix the problem for other ingredients like N-Acetyl-L-Cysteine (NAC), he noted.
Mister also criticized FDA warning letters that don’t get resolved. Retailers and other stakeholders are relying on these warning letters as official positions of the agency, as seen with NAC, where Amazon is removing NAC-containing products from its retail platform. Mister said the agency takes postures in warning letters that may not be grounded in the law. But, Mister emphasized, warning letters are not final agency action. "You can’t sue the agency for a warning letter you don’t agree with," he noted.
In addition, Mister examined claims proximity in the Internet age. "As drug companies 'disease-ify' conditions that were once considered to be life stages and conditions of normal living, where is the line between structure-function claims and claims to prevent, treat, cure or mitigate disease?" he queried. Mister also addressed concerns about labeling quantities of ingredients to account for shelf-life and the intentional overages manufacturers use to comply. He pointed to the flexibility of the drug model as a solution.
Mister spoke as part of a distinguished panel, alongside Scott Bass of Sidley Austin LLP; Carrie Harney of USP; and Cara Welch, acting director of FDA's Office of Dietary Supplement Programs, moderated by Miriam Guggenheim of Covington & Burling LLP. Learn more about the conference, including an address from FDA Acting Commissioner Dr. Janet Woodcock.
Learn more about possibilities—and pitfalls—of DSHEA 2.0 via CRN's webinar, now available on demand.
EU titanium dioxide additive ban imminent
CRN's International Trade and Market Development Committee (ITMDC) this morning received a NewsFlash from IADSA on the imminent ban of titanium dioxide (TiO2) in the European Union (EU). CRN's ITMDC has followed the issue for years, which, as IADSA notes, could "shake up the use of the additive worldwide."
The European Commission and its member states met on May 18 to address the opinion of the European Food Safety Authority (EFSA), which stated that the use of titanium dioxide (TiO2) could no longer be considered safe as a food additive.
It's reported that a ban is now almost inevitable, with questions on:
- Timing—when will the ban will take effect?
- Transition—what will authorities agree to?
IADSA reports there is pressure from EU member states to move briskly.
CRN's Jim Griffiths observed that this issue has been moving through EFSA over several years, with the conclusion understood as inevitable. While it's likely major players with products in Europe are already engaged in reformulation, manufacturers would prefer a transition period to sell through products already on the market. CRN's ITMDC will continue to monitor the issue. Read more via NutraIngredients.com.
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Legislative update: Bills on HSA/FSA inclusion of supplements and on CBD introduced in Senate this week
Senator Kevin Cramer (R-ND) has introduced legislation (S 1654) that would classify nutritional supplements as “qualified medical expenses,”allowing their purchase with pre-tax health savings account (HSA) and flexible spending account (FSA) funds. The bill would amend the Internal Revenue Code to define the term “dietary supplement product” as a nutritional product that is labeled with a statement describing a structure/function claim that affects the human body.
Advancing efforts to include dietary supplements in HSAs and FSAs is one of CRN's priority initiatives for 2021. Their inclusion would provide additional recognition of supplements' foundational value in supporting overall wellness and give middle class Americans a financial boost. HSAs allow users to deposit money into an account for health-related expenses, and when the account is paired with a health insurance plan, the money is deposited tax-free and the funds earn tax-free interest. FSAs have a similar tax-friendly structure and can be set up through an employer to pay for medical and dental expenses. Learn more about CRN's efforts.
Regarding CBD, Sens. Ron Wyden (D-OR), Rand Paul (R-KY), and Jeff Merkley (D-OR) have introduced a new bill—the “Hemp Access and Consumer Safety Act”—to ensure hemp-derived CBD is regulated by FDA like other legal products used in foods, beverages, and dietary supplements. The new Senate bill differs from the House legislation, HR 841, by including food and beverages. CRN's government relations team is reviewing the legislation. Contact Bill Dumais with questions.