Did you know that supplement quality is completely unregulated by the FDA? This is why some supplements when tested by third parties have nothing close to the amount of active ingredient listed. Or worse, some supplements even have dangerous ingredients added. Our favorite example? Several years ago, a male enhancement supplement was found to be laced with Viagra. No wonder why it worked so well! Our least favorite examples? Supplements that are laced with heavy metals or ingredients in toxic amounts that actually kill or maim people. Yuk.
Over the years, the supplement industry has found ways to regulate itself. This has been through various regulatory agencies and practices that have often been borrowed by the pharmaceutical industry..
One of the most important sets of regulations for consumables is the (G)ood (M)anufacturing (P)ractice set of regulations. These regulations ensure that the companies that produce products such as food, cosmetics, pharmaceuticals, supplements, etc. produce products at a consistently high quality from batch to batch.
Read on to find out why GMP is one of the most important sets of regulations when it comes to consumable products.
In the early 1900s there were no federal regulations that protected consumers and workers from dangerous products and working conditions. Chemical preservatives were uncontrolled, milk was unpasteurized, and drugs were largely unregulated.
In 1906, Upton Sinclair publishedThe Jungle, a novel which exposed the horrid conditions of the meatpacking industry. As a result of these revelations, the government was pushed by the public into passing the Pure Food and Drug Act of 1906. While this law was a step forward, there were many gaps that left consumers unprotected.
In 1937, a tragedy occured when the S.E. Massengill Company used diethylene glycol, a.k.a. Antifreeze, in a drug mixture to treat streptococcal infections. This resulted in many deaths from kidney failure. In response, the government passed the Federal Food, Drug, and Cosmetic Act in 1938. This allowed the government to inspect drugs and working conditions before marketing.
In 1962, the Drug Amendments were passed. These amendments further tightened control and regulation of prescription drugs, new drugs and investigational drugs. These amendments formalized Good Manufacturing Practices. Since 1962 many more sets of laws and regulations have been passed to protect consumers from bad manufacturing practices.
What are the (G)ood (M)anufacturing (P)ractices?
GMP has been adopted by many countries around the world. They are each regulated by their respective regulatory agency. However, guidelines usually follows these basic principles:
- Requiring step by step written procedures
- Following of step by step procedures
- Document work (Record keeping)
- Validate work (Make sure there is adherence to procedures and consistent performance)
- Integrate productivity, quality and safety into facilities and equipment
- Maintain facilities and equipment
- Define, develop and demonstrate job competency
- Make cleanliness a daily habit
- Build quality into the product
- Conduct compliance and performance audits
The FDA is authorized to perform unannounced inspections to ensure that companies are in compliance with GMP standards. If a company/product is deemed to be in violation of GMP standards, the FDA can warn the company to recall the product. If there is no recall of the product, then the FDA can warn the public and seize the product.
GMP Importance to Us
Here at Troscriptions we believe in the 3 P’s: Precision Dosed, Pharmaceutical Grade, and Physician Formulated. All of our troches are all produced in an FDA registered GMP facility under the supervision of a compounding pharmacist of over 30 years experience. In addition, all of our troche ingredients come with a certification of analysis or purity and potency and the final troche products are tested as well before they are packaged up…so you can #buccalup!