Harshbarger Introduces Legislation to Fix Outdated FDA Drug Preclusion Rules, Protect Access to Dietary Supplements

Office of Rep. Diana Harshbarger • September 10, 2026

Rep. Diana Harshbarger (R-TN) introduced the Dietary Supplement Innovation Act on September 10, targeting the DSHEA drug preclusion provision that lets the FDA bar an ingredient from supplements if it was first studied or approved as a drug. The bill would protect ingredients marketed before October 15, 1994, allow preclusion to lapse after seven years of inactive drug development, give the FDA authority to grant exceptions by administrative order, and make FDA preclusion warnings immediately reviewable in court with the burden of proof on the government.

New Bill Seeks to Fix Drug Preclusion Provision to Boost Dietary Supplement Innovation

NutraIngredients • September 12, 2026

NutraIngredients breaks down the five provisions of the Harshbarger bill, including limiting preclusion triggers to Phase 2 or Phase 3 trials and removing preclusion language from the statutory definition of a dietary supplement. DSHEA architect Scott Bass called the abandoned-drug fix the most important piece but argued the bill leaves untouched the “supplement the diet” innovation clause in section 201(ff)(1)(E) that the FDA has misapplied for years. The article notes the FDA has invoked preclusion against NAC, NMN and CBD, all ingredients with long histories in the supplement market.

Industry Groups Quick to Applaud Bill to Clean Up Drug Clause

SupplySide Supplement Journal • September 11, 2026

AHPA, CHPA and CRN issued a joint statement backing the bill, with CRN’s Steve Mister saying it restores the balance Congress intended when it enacted DSHEA. SupplySide recounts the NMN saga as the case in point: the FDA ruled the ingredient precluded on the strength of an investigational new drug application filed by a Chinese company long after supplement makers had invested in the market. Industry groups say the current clause can be wielded in an anticompetitive fashion even when drug development has been abandoned.

New Bill Would Reform FDA Drug Preclusion Standard for Supplements

Nutritional Outlook • September 11, 2026

Nutritional Outlook connects the bill to industry’s earlier comments on the FDA’s March public meeting on the scope of dietary ingredients, where NPA cited the NAC and NMN disputes as proof the system tilts toward pharmaceutical development. CRN general counsel Megan Olsen has described the clause as a “race to market” test that companies can lose without ever knowing an undisclosed IND filing existed. NPA has separately asked the FDA to publish a regularly updated list of precluded ingredients and to permit limited disclosure of investigational filings.

FDA Finds Problems at 49% of Supplement Manufacturing Sites

ConsumerLab.com • September 10, 2026

FOIA records obtained by ConsumerLab show that 49.1 percent of the 800 supplement facilities the FDA inspected in fiscal 2025 received Form 483 letters citing cGMP noncompliance. U.S. sites improved to 47.6 percent from 52 percent in fiscal 2020, but foreign facilities fared far worse at 72.5 percent, and every inspected site in India, Japan and Brazil was cited. The numbers will feed the debate over whether DSHEA’s post-market framework is adequately enforced, a question that surfaces in nearly every mandatory listing and registration proposal now before Congress.

All of a Sudden, It’s All About Botanical Drugs

SupplySide Supplement Journal • September 10, 2026

Only four botanical drugs have been approved since the FDA created the pathway in 2006, yet the category is suddenly the focus of a new House bill offering 12-year market exclusivity and an FDA public docket open through November 3. Acting Commissioner Kyle Diamantas framed the effort as modernizing frameworks for natural health options, and a joint workshop with the European Medicines Agency is set for September 25. SupplySide’s Marc Brush warns the push adds to the medicalization trend blurring the line between supplements and drugs at the same time the FDA is reconsidering the very definition of a dietary supplement.

Hemp Industry Gets 30-Day Extension on Federal Restrictions

NutraIngredients • September 14, 2026

The continuing resolution signed September 2 pushed the effective date of new federal hemp restrictions to December 11, 2026, but the 0.4 mg THC-per-container limit remains unchanged and could pull most full-spectrum CBD products off shelves. Regulatory attorney Rend Al-Mondhiry cautions that vague language covering cannabinoids marketed as having THC-like effects could sweep in non-intoxicating compounds such as CBN. The U.S. Hemp Roundtable called the extension a lifeline and is pressing Congress to use the window to write a workable standard and a clear legal pathway for CBD as a dietary supplement.

CRN Tackles AI, Private Equity, Politics Shaping Supplement Industry’s Future

SupplySide Supplement Journal • September 14, 2026

CRN President Steve Mister previews the trade group’s CONVERGENCE conference, set for October 6 to 8 in Carlsbad, California, which will feature a fireside chat with the acting FDA commissioner and sessions on the rising tide of state supplement legislation and MAHA’s influence on NIH and supplement policy. Mister points to a wave of private equity and CPG deals this year involving Thorne, Nature’s Bounty, Kenvue and others as one of the most disruptive forces reshaping the sector. Keynotes will examine why AI investments often fail to deliver productivity gains and how businesses can navigate an increasingly polarized political climate.

SPINS Data Shows Nearly Half of Supplement Industry Growth Concentrated in Two Categories

Nutritional Outlook • September 10, 2026

Protein and performance nutrition now account for 45 percent of all supplement growth, SPINS’ Scott Dicker told the Future Nutra Innovation Summit, while sleep, cognitive, joint and weight-management formulas have flattened or declined and the natural retail channel is shrinking for the first time in years. SPINS data shows 21 percent of households now include a GLP-1 user, and 80 percent of those users take a companion supplement. Dicker said transparency now outweighs formula complexity, with 70 percent of consumers reading ingredient labels and proprietary blends losing ground to clearly dosed branded ingredients.

District Court Invalidates Claims in Ubiquinol Patent

SupplySide Supplement Journal • September 11, 2026

The U.S. District Court for the Eastern District of New York invalidated two claims in Kaneka’s patent covering stabilized reduced CoQ10, dismissing the company’s 2023 infringement suit against Cocrystal Technology for lack of enablement. The ruling conflicts with a 2024 Delaware decision that upheld the same patent, and Kaneka says it will appeal immediately to the Federal Circuit. The dispute matters for a supply chain in which branded ubiquinol has been a premium, heavily licensed ingredient for more than a decade.

Your Voice Matters

The Dietary Supplement Innovation Act needs cosponsors to move. Tell your representative that fixing drug preclusion is essential to preserving the access DSHEA promised, and weigh in on the FDA’s botanical drug docket before comments close November 3.