Wayback Wednesdays

WAY BACK WEDNESDAY: 2014: THE HISTORY OF HERBAL MEDICINES IN THE UNITED STATES PRESENTED AT ASA UNITY CONFERENCE

This panel “The History of Herbal Medicine in the United States” was recorded during ASA’s 2014 Unity Conference. The panel included Dr. Lyle Craker, Peter Hutt, Tony Young, and Jane Wilson, and was moderated by Lewis Grossman.

As we are shaping the federal policies for medical cannabis, it is important to understand that Cannabis is not the only plant that has struggled for legitimacy as a medicine in the United States and how other non-pharmaceutical medical products have moved through phases of federal legality and regulations. These regulations have positive and negative impacts for patients. This panel predicted the issues that we are now seeing with FDA and CBD and highlights pitfall’s in the current regulatory pathway.

ASA has utilized this information and advice from these mentors to guide our legislative proposals, grassroots campaigns, create product safety standards, guide regulations, and to create our Patient Focused Certification Program.

It is important to note that while dietary supplements and herbal medicines are now expressly legal, many of these products have been delegated to class outside medicine and food, often referred to as “wellness products”. This means that their use is not taught about in medical schools, and that these products are out of reach for many Americans because they are not covered by insurance, and they cannot be purchased with food stamps or food assistance funds.

Without the work of advocates and the creation of a grassroots movement, it is likely that herbal medicines would still be considered illegal food additives to this day.

RIP 2022 Lyle Cracker, thank you for all that you taught us. We will keep your work alive.

Below is a deep dive into some of the topics covered in the video adapted from the writings of two of the presenters: Dr. Lyle Craker & Peter Hutt.

THIS HISTORY OF BOTANICAL MEDICINE REGULATIONS IN THE U.S. (adapted from Craker 2003, Hutt 2004)

Medicinal plants were among the first pharmaceuticals used in America. In fact, in the early 1900s, forty percent of the official medicinal preparations were crude plant extracts including cannabis. Cannabis was first introduced in the 3rd Edition of the U.S. Pharmacopoeia in 1851, where it remained until the 12th Edition in 1942.

Pharmaceuticals for early American health care came from the wide array of healing compounds produced in plants. Medicinal herbs were planted near homes and medical facilities and medical-school curricula included training in the use of medicinal plants as pharmaceuticals. Medicinal preparations and medicinal plants were included in pharmaceutical publications through the early 1900s.

In the late 1800s, the commercialization of medicinal plants into cure-all, patent medicines, touted by traveling medicine shows created public and government suspicion about natural products. At the time, all pharmaceuticals used in medical care lacked standardization. False claims connected to unscrupulous practitioners and various companies eventually led to the development of standards in the practice of medicine.

In 1910, Abraham Flexner published a report, commissioned by the American Medical Association and the Carnegie Foundation; known as the Flexner Report of 1910, which suggested that only trained physicians should be allowed to prescribe medicines in the U.S. and encouraged the disuse of medicinal plants in medical practices. The combined impact of the Flexner Report and the rise in political power of the American Medical Association (A.M.A.) resulted in a majority of schools specializing in botanical medicine in the country closing, and within twenty eight years, all schools that taught what is now considered complimentary or alternative medicine had closed, leaving only A.M.A.-approved schools in operation (Craker 2003; Griggs 1981).

The health of people improved through the early 1900s by the recognition of microorganisms as disease agents, the development sanitation procedures that prevented infections, and the formulation of sulphur drugs that fought infections. Vaccines for the prevention of tetanus, yellow fever, diphtheria and other diseases followed in the 1920s, and the potential of antibiotics was recognized after the discovery of penicillin in 1928 (marketed in 1942).

The public, however, was still not protected from harmful or worthless products. Only after a toxic solvent (ethylene glycol) used as a sweetener in the manufacture of a sulphur drug (Elixir Sulfanilamide) resulted in the death of more than 100 people (mostly children) (National Academy of Science 2004, p. 22-23), did the U.S. Congress pass the Food, Drug, and Cosmetic Act of 1938. This law, which legally mandated quality and identity standards for foods, drugs, cosmetics and medical devices, prohibited false therapeutic claims and enabled government inspection of manufacturing facilities.

THE REGULATORY ROLLER-COASTER OF HERBAL MEDICINE

The decline in the use of plant-based medicines after the early 1900s can be traced by changes in the United States Pharmacopeia (U.S.P.), the official U.S. guide to prescription and non-prescription drugs. In 1916, forty percent of the official medicinal preparations were crude plant extracts (United States Pharmacopeia (U.S.P.) 1916). The percentage of plants extracts listed in the Pharmacopeia, however, steadily declined after 1916, reaching nine percent in 1950 and one percent by 1990 (United States Pharmacopeia (U.S.P.) 1950; 1990).

While part of the decline in medicinal plant extracts recorded in the Pharmacopeia can be explained by an increase in the number of refined or synthetic drugs, the data actually indicates a significant reduction in the number of included plant extracts, decreasing from approximately 299 preparations in the 1916 Pharmacopeias. Herbal remedies, such as St. Johns wort (Hypericum perforatum), echinacea (Echinacea spp.) and saw palmetto (Serenoa repens), which became popular in the late 1990s, were added to the Pharmacopeia in 2004 (United States Pharmacopeia (U.S.P.) 2004).

The Federal Food, Drug and Cosmetic Act of 1938 (FD&C Act), authorized regulations governing the labeling of food “for special dietary uses” requiring the labeling of both fortified food and dietary supplements. During the 1950s, FDA, with the assistance of the Federal Trade Commission (FTC),launched an intensive enforcement campaign in that included seizures, injunctions and criminal actions in the courts against what the agency concluded were misbranded dietary supplements.

When this failed to slow the steady expansion of the dietary supplement industry, FDA abandoned court enforcement and proposed new regulations designed to limit both the specific nutrients and their levels in dietary supplements. These regulations became the subject of the infamous evidentiary trial-type hearing before an Administrative Law Judge in 1968 and 1969, where FDA and the industry proffered testimony of 162 witnesses and introduced into evidence more than 2,000 documents.

FDA pushed ahead following those hearings, publishing final regulations in 1972 that mirrored a 1962 proposal. But in 1974, the U.S. Court of Appeals for the Second Circuit overruled parts of the regulations and stayed the remainder. Sen. William Proxmire (D-Wis.) spearheaded enactment of the Vitamin-Mineral Amendments of 1976, which further reduced FDA flexibility in regulating dietary supplements. Recognizing momentum had been lost, in 1979 FDA revoked all of the regulations it had promulgated in 1972, including those that had been upheld in the courts.

THE MOVEMENT THAT BROUGHT CONTEMPORARY USE AND REGULATIONS OF HERBAL MEDICINES

1980s, the American concept of medicine began to broaden from the conventional medical doctor prescribing a pill to cure an illness to include alternative medical systems that promoted a healthy lifestyle and the use of medicinal plants for prevention and treatment of illnesses.

In 1990, the Nutrition Labeling and Education Act (NLEA) was passed giving FDA the authority to approve disease prevention claims for all foods, including dietary supplements. In 1993, then, FDA Commissioner, David Kessler, M.D., announced that the FDA would not approve any proposed disease prevention claims for dietary supplements and that the FDA would treat dietary ingredients other than essential vitamins and minerals as illegal food additives and remove them from the U.S. market.

In response, the dietary supplement industry mobilized a grassroots campaign comprised of health food stores, consumers, and medical professionals to campaign Congress to intervene. This campaign utilized the 1994 congressional election to bring the message of FDA taking away their freedom to consume dietary supplements. The issue became a key electoral issue and just weeks before the election, the dietary supplement industry’s most powerful opponent in Congress, Rep. Henry Waxman (D-Calif.) reached out to the industry to negotiate a dietary supplement law. Soon after Congress passed the Dietary Supplement Health and Education Act (DSHEA),

The passage of this law established medicinal botanicals as dietary supplements, an adjustment that categorized herbal medicinal products as foods, limiting the power of the FDA to restrict sales but also limiting their integration into mainstream medicine.

DSHEA created a specific definition for dietary supplements and defined FDA enforcement authority, including the ability to remove from the market products the agency deems unsafe through: 1) an “imminent hazard” clause which permits FDA to immediately remove a product it considers to present an immediate safety concern and 2) a “significant or unreasonable risk” clause that allows removal of a product considered to pose an unacceptable risk of illness or injury.

Enactment of DSHEA helped consumers better understand and accept herbal medicines, which created a rapid expansion of the herbal products industry. Sales of herbal products at the retail level more than doubled over the next few years. Use of dietary supplements is now common and increasing among the U.S. adult population; supplement use went from over 40% between 1988–1994, to over 50% between 2003–2006 (National Center for Health Statistics, 2011).

In 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which requires manufacturers to notify the FDA of all serious adverse events associated with an over-the-counter drug or a dietary supplement that they receive.

In June 2007, Good Manufacturing Practices (GMP) specific to herbal products were released from FDA. These GMPs were largely based on standards that hand been created by groups such as the American Herbal Products Association. Many companies supported the need for these GMPs in order to create a level playing field within the industry and increase consumer confidence in the quality and safety of these products. 

CONCLUSION

The regulatory path of herbal medicines was not a simple one, and it is important to note that while dietary supplements and herbal medicines are now expressly legal, many of these products have been delegated to class outside medicine and food, often referred to as “wellness products”. While this is a step forward, this also means that their use is not taught about in medical schools, and that these products are out of reach for many Americans because they are not covered by insurance, and they cannot be purchased with food stamps or food assistance funds.

Without the work of advocates and the creation of a grassroots movement, it is likely that herbal medicines would still be considered illegal food additives to this day.

If you appreciate ASA's work, join now to become a part of the movement and sign up to get ASA's monthly newsletters and updates.