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Lack of clinical research in US overcrowding the herbal marketplace

Updated: Apr 10, 2018



It may come as no surprise that the herbal supplement industry is a bit overcrowded. Scanning a health food store aisle for plant medicine is much like locking eyes with a wolf in sheep’s clothing. Free enterprise has multiplied products so violently that even smart consumers are undermined. The Dietary Supplement Health and Education Act (DSHEA) of 1994 began as an attempt to maintain control over the health food industry by supplement companies who feared the FDA would ruin their industry. In the latter half of the 1980s into the early 90’s, there were a number of acts circulating that would increase FDA’s control over the supplement industry. Many in the health food’s business viewed the FDA as a power hungry dictator.


The DSHEA essentially keeps the health food industry out of the reign of the FDA and keeps the FDA out of health food industry’s hair. FDA treats herbal supplements the same as food. Though the manufacturer must include more information on their product, like, ingredients, distributor, packer, manufacturer, nutritional information, safety, and the obligatory “This statement has not been evaluated by the FDA...This product is not intended to diagnose...” They do not need to submit any evidence or research to the FDA for approval to market their products. The onus is on the manufacturer to not make misleading claims but the FDA does not ensure these claims are true. Fortunately, they cannot advertise themselves as treating or preventing disease but they can get pretty darn close. And so, chaos ensues.


Let us take a gander at how other countries treat the herbal industry. In India, the Drug and Cosmetic Act and Rules 1945 place the control of the industry under their health systems: Ayurveda, Unani and Siddha. The Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy) oversees all manufacturing and marketing of herbal products. They maintain industry standards for every product on the market, including using officials pharmacopeias for formulas and licensing all herbal products into two categories: Ayurvedic, Unani and Siddha medicine or patented or proprietary medicines. In Nigeria, herbal products are under the control of the National Agency for Food and Drug Administration and Control (NAFDAC), which has a separate category for “Herbal Medicines and Related Products.” All manufacturers must register their products and all advertisements and claims made are first cleared with the NAFDAC. In Saudi Arabia, herbal products are considered traditional products and they must have at least 50 consecutive years of use to make it to market. This includes the dosage and how the medicine has traditionally been prepared in the last 50 years. In Australia, the Therapeutic Goods Administration (ARTG) considers herbal products a subcategory of complementary medicine. All complementary medicines are cleared with the ARTG before they can be marketed, including all claims on the products, which must be evidence-based. In Canada, all natural health products must register with Health Canada before they can begin making their products. Registration is an exhaustively detailed process, which includes testing on microbial and chemical contaminants and product composition and standardization. In the EU, the European Medicine Agency separates herbal products into two categories. The first are products which have their long history of traditional use, which is considered sufficient evidence and have generally been used for longer than 15 years. The second are products which must provide thorough physiochemical and pharmacological tests and clinical trials data.


All this necessary infrastructure holds companies accountable and ensures quality control. Without this, shelves are congested with too many choices, some of which are plain fraudulent. In 2015, there was an investigation of herbals supplements from big industry players: GNC, Walmart, Target and Walgreens. The tests showed only 21% of the supplements actually contained the plants claimed on the bottles. The rest were fillers! Including (not limited to) rice, beans, citrus, houseplant, wild carrot, pine, wheat, and asparagus.



In other countries, research runs the herbal market. In the US, competition runs the herbal market. Even companies that have done extensive testing on their products get lost among noise of knock-offs. The price we pay for the freedom of choice is flirting with industry charlatans.