The truth about organic supplements

Writtne By Jon Barron

The basics about GMP

It seems that almost every day now, the news is filled with stories about how supplment manufacturers are lying to consumers about their products–the same products we buy and trust to safely feed or supplement our family and children.

GMP_imageOne industry standard that helps keep manufacturers honest is cGMP, which stands for current Good Manufacturing Practice. Today you’re going to read about a shocking, mind-blowing example connected to the Natural News Forensic Food Lab as to why it matters. And despite its name, cGMP is not just about manufacturing. When it comes to supplements, cGMP applies to everything in the process–up and down the line. GMP is a set of guidelines that provides a system of processes, procedures, and documentation to ensure that the finished product has the identity, strength, composition, quality, and purity that it claims. And, it is important for the readers of this website, Organically In Tune.com, to understand cGMP so you can know whether or not you can trust the supplements you buy. We really do care about good quality products as much as you do when purchasing with your hard earned dollars.

Manufacturers are bound to GMP. Additionally, companies that just store and/or distribute supplements are also legally required to comply with GMP regulations–with the exception of brick and mortar retailers. But online retailers such as Organically In Tune.com are bound by it.

Many manufacturing outlets that specialize in supplying raw ingredients for supplements likewise have to follow a version of GMP, as do the testing labs that verify the purity and content of the supplements you consume. It’s the law, we’re all required to follow cGMP. But that doesn’t mean that everyone does. While most (but not all) manufacturers do and most testing labs do, it turns out that many ingredient suppliers do not (although they are required to follow Food GMP requirements), and very few retailers do. Why  do they not follow the requirements?

Primarily because running a GMP compliant supplement operation is very expensive and time consuming. Following GMP really requires a full time Quality Assurance person. In fact, the FDA actually calculated the costs involved. The numbers they came up with are a bit shocking…

The costs associated with setting up a company following GMP

Small Companies  (Less than 20 employees with annual revenue under $1M)

  • Set up Costs = $26,000
  • Annual Costs = $46,000

Medium Companies  (20 – 500 employees with annual revenue of $5M – $10M)

  • Set up Costs = $20,000
  • Annual Costs = $184,000

When a company takes on that much cost to become compliant, it can’t just eat it. They have to pass it on to their customers, which means higher prices, which means you’ll be less competitive than those who aren’t GMP compliant. And that’s amplified up and down the chain.

For example, in complying with GMP, Baseline Nutritionals is required to work only with GMP manufacturers, warehousing facilities, fulfillment houses, and testing laboratories–all of which cost more than their non-compliant counterparts, which means that each and every one of those additional costs gets added to the final retail cost. You can see by the numbers above that it just is not possible for all companies to get and stay compliant.

All of the Private Label products that we offer here on this website, Organically In Tune.com, include verified potency ingredients and we can show you the documentation on request.

Is your favorite brand maintaining GMP compliance?

Maintaining compliance is also a major pain in the butt. Many companies have gone out of business because they could not afford the extra time it takes or the extra cost to become compliant. Other companies have just ignored it and hope the FDA doesn’t come calling. Among other things, it requires regular onsite auditing of any company we work with to make sure they are GMP compliant. And when I say auditing, I’m not talking about simply visiting and saying hi. I’m talking about anywhere from a half day to a day-and-a-half, inch-by-inch walk through while working your way through a staggeringly detailed check list.

To give you just one idea, when auditing a manufacturing operation, we need to make sure that no tree branches are growing too close to a facility as that could be an access point for squirrels and rats into the facility. And that’s just one of a number of items we have to check for even before we actually enter the facility. Trust me; it’s extensive, time consuming, costly, and it’s a pain.

So is it worth it? You decide. We like to present the facts and let you decide on your own. That is what a good news reporting website will do.

record_keeping_imageRegardless, cGMP compliance requires extensive record keeping and requires access to these records by the FDA on demand. Identity testing must be performed on every dietary ingredient used in each and every batch of a formulation. This can be performed by the manufacturer or by the ingredient supplier, but the manufacturer is ultimately responsible for verifying the reliability of the supplier. Note: although ingredient suppliers are exempted from the regulation–putting the burden for compliance on the manufacturers–most manufacturers require their raw material suppliers to meet these regulations or they won’t do business with them. And as mentioned earlier, the raw dietary ingredient suppliers are still subject to Food GMP regulations.

What are some of the items that GMP covers?

According to the FDA’s own website, current Good Manufacturing Practices (CGMPs) require that proper controls be in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards.1 The CGMPs apply to all domestic and foreign companies that manufacture, package, label, or hold dietary supplements, including those involved with the activities of testing, quality control, packaging, and labeling (an important consideration as we will see later), and distributing them in the U.S (i.e. selling them). The requirements include provisions related to the design and construction of physical plants that facilitate:

  • Maintenance
  • Cleaning
  • Proper manufacturing operations
  • Quality control procedures
  • Testing final product or incoming and in-process materials
  • Handling and recording consumer complaints
  • Maintaining records

Although the requirements are not as rigorous as found in the pharmaceutical industry, much of the wording and intent is the same. Specifically, anybody involved in manufacturing and distributing dietary supplements is required to keep detailed records documenting all standard operating procedures (SOPs) and they must have a formal process for reviewing and updating SOPs. In addition, training records for all employees must be kept current and a master manufacturing record for all formulas must be maintained. That said, there are differences. For example, drugs have to be FDA approved before marketing, whereas dietary supplements do not. Another important difference is that drug testing must be done for all active components in a pharmaceutical product, but there are exceptions available for dietary supplements. Also, equipment and analytical methods have to be fully validated for drug products, but only qualified for supplements.

So as always we would like to hear your feedback on this and all of the articles we post. Please use the contact us form and feel free to speak your mind!

Thank you

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