The Food and Drug Administration opened a public docket on September 4, seeking input on how to accelerate the development of botanical drug products, which the agency defines as drug products that include or may be derived from plant material, algae, macroscopic fungi, or combinations of them. Comments are due by 11:59 p.m. Eastern on November 3, 2026.

The notice covers clinical trial design, batch-to-batch consistency, and regulatory clarity. It does not ask a question that matters to forest landowners across the eastern United States: where the plant material would come from. That question is already being answered in Appalachian hollows this month, because the wild harvest season for American ginseng opens in September in every state that permits it.

For rural households in West Virginia, Kentucky, Tennessee, North Carolina, Virginia, Ohio and a dozen other states, this is not abstract. Wild ginseng and goldenseal are cash crops dug from private woodlots each autumn, and both sit in Appendix II of the international treaty that governs trade in species at risk from commercial demand.

A Federal Docket That Stops Short of the Forest Floor

The request for information is the agency's attempt to understand why so few plant-based medicines meet the same approval standard as any other prescription drug. To date, four botanical products have been approved for marketing as prescription drugs, three through new drug applications containing sinecatechins, crofelemer and birch triterpenes, and one through a biologics license application containing anacaulase-bcdb. Some botanical active ingredients, including psyllium and witch hazel, can be marketed under over-the-counter monographs instead.

One question in the notice reaches directly toward the woods without naming them. The agency asked what regulatory and other challenges arise in developing minimally purified or whole plant products versus highly purified or isolate products. That distinction is the same line that federal wildlife regulators drew decades ago, from the opposite direction.

Under the Convention on International Trade in Endangered Species, American ginseng has been listed in Appendix II since 1975 because of concerns about overharvest for international trade. According to the U.S. Fish and Wildlife Service, the listing covers whole live or dead plants, whole and sliced roots and parts of roots, including root fibers. It excludes powder and manufactured finished products such as teas, capsules, extracts, and confectionery, along with seeds. Goldenseal was listed in Appendix II at the tenth Conference of the Parties, effective September 18, 1997, and the agency's implementation notice described that listing as covering live plants and whole and sliced roots and root parts while excluding manufactured derivatives.

In practical terms, the raw root needs an export permit. Many finished products made from it do not. A finished botanical drug would sit on the unregulated side of that line while the material it was made from sat on the controlled side.

Nineteen States, One Tribe and a Season That Opens in September

Nineteen states and the Menominee Indian Tribe Reservation of Wisconsin allow the harvest and trade of wild American ginseng under conditions they set themselves. The Service reports that in all 19, the season starts in September. Those states are Alabama, Arkansas, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Minnesota, Missouri, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Vermont, Virginia, West Virginia, and Wisconsin.

West Virginia offers the clearest picture of how the system works on the ground. State law sets the digging season from September 1 through November 30. The Division of Forestry requires that plants be at least five years old with at least three prongs, that seeds be planted at the harvest site, and that all roots dug in the state be weighed and certified. Diggers have until March 31 to sell to a registered dealer or obtain a weight receipt, and possession without one is prohibited from April 1 through August 31. Digging on state forest land is prohibited, and digging on other private land requires prior written consent.

Federal oversight sits on top of that. The Service issues export permits only after making two determinations: that the roots were legally acquired under state and tribal rules, and that shipping them will not harm the species' survival in the wild. The framework appears at 50 CFR 23.68, and all wild and wild-simulated roots for export must come from plants at least five years old and be certified by the state or tribe before leaving it.

The Service does not treat the arrangement as secure. Without cooperation from diggers, dealers and exporters, the agency warns on its permit page, wild ginseng could disappear from forests, along with the livelihoods of people who depend on it.

Recent Research Questions the Age Rule at the Center of Harvest Law

The five-year, three-prong standard that anchors most harvest and export rules drew scrutiny this summer. A study published July 14 in Environmental Research Letters, led by Karam C. Sheban of the Yale School of the Environment with co-authors Mark Bradford and Marlyse C. Duguid, tested whether plant age actually predicts the traits conservation rules are meant to protect.

It largely did not. After measuring hundreds of ginseng plants, the researchers reported that age was a weak guide to how large a plant's root had grown or how many seeds it could produce. The authors argue that shifting to size-based limits would protect reproductive capacity better while being easier for harvesters and forest farmers to follow.

The limits matter as much as the findings. The university's summary says the current age-and-leaf-count rules poorly predict the biological traits that matter most for conservation. But this is one study, framed substantially around forest farming and wild-simulated plantings rather than unmanaged wild stands, and it proposes a policy change rather than documenting one. No federal or state agency has proposed changing the age standard, and the existing rules remain fully in force this season.

Digging Rules, Public Land Limits and the Data Gap Between Agencies

Harvesters should treat public land as closed unless proven otherwise. The Service states that ginseng harvest is illegal on most state lands, all National Park Service land and all national wildlife refuges, and prohibited in most national forests. A limited number of national forests allow it with a Forest Service permit, which must be obtained from the local forest office before digging. Private land requires the owner's written permission in West Virginia and comparable documentation elsewhere.

Households considering a first season should start with their state regulatory agency rather than online guidance, since age requirements, license rules, and selling windows differ. Some states require plants to be 10 years old with three or four prongs rather than five years and three. Selling to an unregistered dealer, digging out of season, or taking underage roots can carry civil and criminal penalties, and roots cannot legally be exported without state certification and a federal permit.

What remains unknown is whether any of this connects to the drug docket at all. The agency has not said whether sourcing or supply sustainability will be considered, has not named any wild-harvested domestic species as a development priority, and has not indicated whether it will coordinate with wildlife regulators. Whether accelerating plant-based drug development would increase pressure on wild populations is an open question that no agency has publicly analyzed.

Anyone with a view on that can file it. Comments go to docket FDA-2026-N-9550 on regulations.gov, and the agency has said late, untimely filed comments will not be considered. Forest farmers, state foresters and harvesters are exactly the constituency a drug-development docket rarely hears from, and the November deadline is the only scheduled opportunity in this proceeding.

What Readers Want to Know

What did the FDA announce on September 4?

It opened a public docket requesting information on advancing the development of botanical drug products, seeking input on research challenges, quality control, and possible regulatory changes. Comments close November 3, 2026.

Does this change any rule about harvesting ginseng or goldenseal?

No. The notice is a request for information from a drug regulator. Harvest rules are set by state and tribal agencies, and export rules by the U.S. Fish and Wildlife Service under CITES. None of them have changed.

Why are ginseng and goldenseal under international trade controls?

Both were listed in CITES Appendix II because of overharvest driven by international demand, ginseng in 1975 and goldenseal effective in 1997. Appendix II covers species that are not necessarily threatened with extinction but could become so without trade controls.

When can wild ginseng legally be dug?

In all 19 states that permit it, the season starts in September. West Virginia's runs September 1 through November 30. Dates, age requirements, and licensing differ by state, so harvesters should confirm with their state agency.

Can ginseng be harvested on public land?

Generally no. It is illegal on most state lands, all National Park Service land and all national wildlife refuges, and prohibited in most national forests. A few national forests allow it only with a Forest Service permit.

Does a CITES permit apply to herbal capsules and teas?

No. The ginseng listing covers live plants, whole and sliced roots and root parts. Powders and manufactured finished products such as teas, capsules, and extracts are excluded, as are seeds.

How can harvesters and forest farmers weigh in on the FDA docket?

Comments can be submitted through regulations.gov under docket FDA-2026-N-9550 until 11:59 p.m. Eastern on November 3, 2026. The agency has said late submissions will not be considered.