When it comes to developing quality cannabis products for the wellness market, it is wise to consider the history of the nutraceutical industry, which is littered with examples of low, or no, quality control for ingredients. There are many superficial similarities, and we should learn from past mistakes. Partly, they were products of rapid growth. Starting in the late 1980s, the nutritional industry grew from small-scale, niche producers to a massive, global marketplace, driven by new ingredient innovation. For many years, regulations concerning quality of supplements and NHPs in the US and Canada struggled to keep up. It took the FDA 13 years from when it was granted Congressional authority to develop good manufacturing practices (GMPs) to releasing a GMP final rule in 2007. Industry responded, backed by a vigorous FDA inspection programme, and product quality improved. Product quality failures do still happen; however, in the Fall of 2013, the FDA encountered an outbreak of severe hepatitis linked to aegeline, which had been rushed in as a replacement for another dietary ingredient that lacked an identity and safety dossier — 1,3-dimethylamylamine (DMAA). Manufacturers introduced aegeline without submitting a new dietary ingredient (NDI) notification and performing the identity and safety studies required by US law, with serious health consequences for consumers.
Regulations are key to protecting people’s health and to ensuring a thriving nutritional industry. With Dosecann’s background in the pharmaceutical space, safety and quality drives decisions over product development. Auxly is setting the bar for safe, high-quality cannabis-derived products, and is taking a science-driven approach to substantiate any marketing claims. Oversight of marketing claims is one area where the nutritional industry has been historically lax. In 2012, the US Office of the Inspector General (OIG) reported an analysis of 127 dietary supplements marketed for weight loss or immune system support. The OIG reported that only 66 of 104 manufacturers submitted substantiation documents in response to their requests for information; most were not derived from human studies, and just over half qualified as background information for supplements. Ten percent had no apparent significance in supporting any structure/function claims made about the product. The most damning conclusion was that none of the documents met all of the FDA’s recommendations for competent and reliable scientific evidence.
Read more at nature.com