Why Smart Biohackers Demand GMP Certification

The naive consumer often has this misperception that if something is for sale on store shelves or online it must be credible - it must have received some sort of stamp of approval from a concerned and responsible objective third-party. Unfortunately, this is pretty far from reality with a lot of products, especially health supplements and Nootropics. The dirty secret of the supplement industry is that it’s almost totally unregulated. Many of those suspiciously cheap products in shiny bottles you see for sale on Amazon are untested, impure, expired, and sometimes even fake. Amazon has no standards for what is sold in their vast online marketplace. There are a couple of consumer pro tips that you should already know, don’t buy the cheapest option, check expiration dates, read reviews online, etc - but when buying supplements, something that you consume, which is going to potentially impact your health you need to be a little more discriminating, have some standards. Before ordering or consuming a supplement you should demand to see a Certificate of Analysis (as we’ve discussed elsewhere) and you should also demand GMP, which stands for Good Manufacturing Practice. If you’re not buying GMP-certified, the supplements you consume could have been produced in a dirty Chinese factory or literally in some guy’s bathtub in an apartment, you really don’t know. To further muddy the waters, approximately 45% of supplement brands falsely label their products as GMP certified when they aren’t. All it takes is copy-pasting a generic GMP stamp onto a product’s packaging or website. Amazon and certainly your local pharmacy or vitamin shop are NOT going to double-check that they are selling real GMP supplements - that’s what you need to do.Legit GMP-certified supplements are transparent and publish their products verifiable LOT#s. What does GMP mean? According to Wikipedia: The main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and the product has been checked for quality more than just at the end phase. The chief objectives of GMP certification... Manufacturing facilities must maintain a clean and hygienic manufacturing area.Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use.Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary.Instructions and procedures must be written in clear and unambiguous language using good documentation practices.Operators must be trained to carry out and document procedures.Records must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations must be investigated and documented.Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form.Any distribution of products must minimize any risk to their quality.A system must be in place for recalling any batch from sale or supply.Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken with respect to the defective products and to prevent recurrence. If you are in need of a cure for insomnia, I recommend reading the FDA’s 21-part GMP compliance guide for dietary supplements. To achieve and maintain GMP accreditation American labs and facilities that synthesize and create supplements need to remain compliant with hundreds of stringent standards. If you choose GMP supplements you can be confident that you’re consuming the real thing and you can be optimistic that they will have the desired effect on your health and well-being. Share this with a health enthusiast, that orders things from Amazon… Support me on Substack? For $7/monthly? This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit jonathanroseland.substack.com/subscribe