In the United States of America, there are 4 regulatory classifications as it pertains to botanicals and herbs:
- Food
- Dietary Supplement
- Over the Counter Medication (OTC)
- Prescription Drug (Rx)
The DSHEA or the Dietary Supplement Health and Education Act of 1994 states that most herbs and botanical ingredients must be regulated as dietary supplements. We will go over how the DSHEA is used to regulate herbs and botanicals in the US, how they were subject to regulation and enforcement historically before the existence of the DSHEA, and how the DSHEA came into being to provide this regulatory framework. The DHSEA also goes on to encompass outlining regulatory requirements for either over the counter or prescription based drugs that contain botanical ingredients.
Food, medicine and clothing has often been derived from plants across all countries on the planet throughout their various life cycles. The estimation for the percentage of plants used in producing medicine ranges from 10 to 15 percent across 300,000 higher species. Yet only 1 percent of plants are used for the purposes of producing food or food related byproducts. In the early 1900’s and prior to that, plants were the primary means of medication in the United States. The majority of them were listed in the United States Pharmacopeia, and were prescribed by the doctors of the time. Concoctions made from herbal ingredients were the primary go to remedies of the times.
The Food and Drug Administration was handed the authority to regulate drug safety standards as well as enforce them in 1938, and this is the year that marked the official start of regulation of medicine in the United States. The Food, Drug and Cosmetic Act had accountability rest with the FDA in screening and enforcing possible unethical, criminal and unsafe practices using drugs, cosmetics and food, as well as the mislabeling of them for fraudulent purposes in addition to chemical modification using ingredients or formulas deemed to be unsafe or not provide the desired effect to a patient.
Botanical based treatments paved the way for the creation of stronger, more chemically synthesized drugs, as a result of demand during World War 2, especially in the area of antibiotics and medication used for treating trauma of all sorts. The federal government gave incentives to pharmaceutical companies traditionally known for their production of botanical ingredient based medications, to shift to more chemistry based drugs. These companies were Merck, Lily and Parke-Davis. Single-entity chemicals had proven themselves to have an increased consistency, were easier to measure and more specifically focused to achieving a certain effect while avoiding others than their herbal forefathers.
In 1951, the Durham-Humphrey Act was passed by Congress to outline a regulation in which any chemical based drug that would be too toxic in certain amounts or have serious adverse effects to the human body in certain quantities must be supervised and administered by an individual screened and licensed by a legal body that vests in him the authority to give out such a drug to the uneducated masses who would take that drug.
Drug manufacturers as a result were also forced to label their drugs as either Rx, which means prescription, or OTC, which means over the counter.
In 1962, the Food, Drug and Cosmetic Act was amended and additional clauses were added to include the testing and screening of drugs, so that advertisers could label them to be “proven safe and effective”. The FDA subsequently followed up with instructions regarding requirements for safety and efficacy testing to have a drug qualify for their approval. Approval became mandatory before marketing of the drug to the public for consumption. Older drugs that were being sold prior to these rules coming into effect were allowed to continue being sold and marketed as long as their ingredients and labels remained the same as before.
In 1972, the FDA commenced a thorough review of all over the counter medications to evaluate their safety and efficacy. Medications that were found to be mostly safe and effective (GRASE) were labeled a Category 1 and given the green light for marketing efforts. Ingredients found in previously issued OTC drugs that were deemed to be unsafe or ineffective were taken off the OTC list and labeled a Category 2 drug, and were no longer allowed to be sold as over the counter medication or forced it’s manufacturer to change the recipe so they did not use those ingredients if they wanted to sell the drug as OTC. If it was difficult to test safety and efficacy due to a lack of data regarding the ingredient to identify it’s effects more well, they were labeled Category 3.
Due to the lack of commercial sponsors willing to spend money on research into botanical ingredients, that were previously found in many over the counter medications, they were either moved into Category 2 as a precaution or in Category 3. Post 1972 the number of botanical ingredients still classified as drugs under the act had significantly diminished, producers of herbs had to market their products as a food supplement as opposed to a medication.