How is Herbalism Regulated in the United States?

Herbal remedies have always been with us, but in the modern era they've developed alongside medical science as a popular and warmly valued supplement to surgery and drug-based medicine. Nearly 1 in 5 Americans say they use herbal or natural approaches to whole-body health, with many more occasionally using milder remedies (such as herbal tea) without strictly thinking of it as a medical treatment. Every new medical procedure and treatment is monitored by the Food and Drug Administration (FDA), with plenty of monitoring and compliance requirements. Even over-the-counter medicines, such as headache pills, are legally required to be the same, down to the molecule, as each other. Herbal supplements, however, are in a different system altogether, and the field's practitioners operate in a special legal realm of their own.

Medical Regulations, State vs. Federal Rules

The first thing to know about regulations in the United States is that there's a huge gulf between the federal and state systems. While plenty of exceptions exist, prescription drugs are approved for sale by the federal government through the FDA. The federal government also exercises vast power over how medicine is done through Medicare and Medicaid, which pay most medical practitioners in the country through the Center for Medicare/Medicaid Services (CMS). CMS sets standards of care, and facilities that don't meet them may have their ability to receive payments suspended or canceled, effectively making them unprofitable.

How are Herbal Remedies Different?

The FDA has an interesting gap in its regulatory coverage. While all prescription and OTC medicines are subject to direct control, and food products sold in interstate commerce (i.e. all of them) are regulated, herbal supplements are neither of these. They're not food, and they aren't drugs. Instead, the FDA takes a split approach to herbal treatments. People in the United States are totally free to make any herbal preparation or personal supplement they wish without regulations, unlike penicillin, which you're generally not supposed to make in your kitchen. It's only when you go to offer these products for sale that you bump into the law.

FDA regulation of herbal supplements is almost entirely confined to making sure the products offered for sale are not harmful or impure. Under Title 21 CFR, the FDA requires herbal products to follow what it calls Current Good Manufacturing Practices (cGMPs), sometimes called GMPs in older documents. If you plan to sell your preparations, your production needs to be cGMP-compliant, which usually means tons of documentation for the whole manufacturing process, plus minimum hygiene and product safety rules. If this is too much for your poor garden to manage, and we don't blame you if it's overwhelming, you can usually outsource your production to an already-certified cGMP-compliant facility. This adds cost, but it saves a lot of paperwork and inspections.

What About Practitioners?

Herbal practitioners are in a similar gap between regulations, since they are neither medical doctors (as a rule), nor food distributors. Moreover, because herbal and natural remedies don't typically get Medicare or Medicaid funding, practitioners of herbal and traditional treatments are entirely free from government management on the federal level. Exceptions to this rule are few and far between, and they almost always involve a specific agent being imported, sanctions on a specific source country or the banning of an individual product, such as products containing ephedra, which were banned nationwide in 2004, with a federal court upholding the ban in 2006.

How is Herbalism Regulated at the State Level?

Nearly all of the regulations for herbalists happen on the state level. This is also true for related professions, such as massage therapists, naturopaths, reflexologists, chiropractors and so on. Unlike the fairly uniform standards states set for medical doctors, these rules show a lot of variation from state to state.

This can get complicated, but there's a sharp distinction between naturopaths who also work as physicians, and who thus must be licensed to practice naturopathy in every state, and non-physician herbalists and naturopaths, who can practice without a license in 28 states. All of the states that license herbal naturopaths use the same standardized test, called the Naturopathic Physicians Licensing Exam (NPLEX), which is administered by the North American Board of Naturopathic Examiners.

Non-physician herbalists are required to hold a license in these 22 states:

• Alaska

• Arizona

• California

• Colorado

• Connecticut

• Hawaii

• Idaho

• Kansas

• Maine

• Maryland

• Massachusetts

• Minnesota

• Montana

• New Hampshire

• New Mexico

• North Dakota

• Oregon

• Pennsylvania

• Rhode Island

• Utah

• Vermont

• Washington

Traditional Chinese Medicine (TCM) is another edge case. Chinese herbalism is a subset of wellness approaches that has its roots in the ancient practices of China, and its practitioners are licensed by a private agency, the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM). NCCAOM is not part of the government, but it is a reputable and widely respected trade association and all 50 states require TCM practitioners to hold accreditation from it.

What's the Bottom Line?

Regulations regarding herbal approaches to health are as diverse as the remedies themselves. There's a fair amount of safety regulation in place, but you should always check local, state and federal laws to make sure you, or your practitioner, are in compliance. And of course, only work with herbalists you trust, ideally those with professional accreditation.