Going Above & Beyond: Our Standpoint Regarding cGMPs

At NutriGold, we take great pride in our accountability and transparency commitment. We are proud of the fact that we go above and beyond what’s required under current Good Manufacturing Practices (cGMPs) when it comes to ensuring the safety and overall quality of our products. In fact, we have one of the most comprehensive raw material and finished product testing programs in the industry and are one of less than a handful of companies to make lot-specific finished product Certificates of Analysis freely available to consumers on our website. But, it is hard to fully appreciate what we offer without having some background knowledge of what current GMPs are and what it means to be compliant with the required regulations.

So, what exactly are GMPs? Aren’t all dietary supplement companies GMP certified? What sets NutriGold’s testing program apart from the rest? How does NutriGold compare to other dietary supplement companies when it comes to complying with good manufacturing practices (or GMPs)? How do I find out if a company is complying with GMPs and that the product I am purchasing has been verified to meet label claims? Read on to find out more about what all of this means for you, as a consumer, and what you can do to verify that you are entrusting your health and your business to the company that is right for you!

• Current Good Manufacturing Practices (cGMPs, for short) are regulatory requirements set forth by the FDA that all dietary supplement companies are required to comply with to ensure the safety of the products that they distribute.
• Among other things, cGMPs require companies to ensure that the products they are distributing meets all of the claims made on the label (and at points of sale) so customers can be assured that they are getting what they are paying for.
• It is important to note that GMP requirements define only the “minimum” standards companies have to meet to distribute their products; some companies do more than what is required and, by the same standard, some do less and some others do virtually nothing.
• GMP requirements are not “all-inclusive” or “absolute,” which means each brand can define and develop its own quality and testing standards and still claim that its products meet FDA regulations.
• Buried elsewhere in a related regulation (21 CFR 101.9) is the requirement that products must contain at least 100% of the amount claimed on the label to be eligible for distribution. For example, if a product claims 100 mg vitamin C per capsule on the label, the product must contain 100 mg per capsule, or it should not be distributed.
• The only problem with cGMP regulations? The FDA does not verify every supplement label to make sure it is accurate and truthful before the product is distributed. The unintended consequence? A marketplace that is flooded with products of varying quality, many of which don’t contain even a fraction of what is claimed on the label.
• The FDA does not certify companies or products as GMP compliant or GMP certified. Beware of companies that make such claims.
• While third-party providers like the NSF offer NSF GMP registration (for manufacturing facilities) and NSF GMP certification for products, this does not guarantee that the specific lot of the specific product you intend to purchase has been verified to meet label claims.

Bottom-line, as consumers, you are entitled to the reasonable expectation that the product you are purchasing contains what it claims to contain on the label, and manufacturers (or brands) have an obligation to ensure such expectations are consistently met. However, when it comes to finished product verification, not all brands are created equal. As you can see from the illustration below, many brands do not perform any testing, some brands perform at least some testing , few brands do what’s required under GMPs, and NutriGold does more than what is required.

On one end of the spectrum are brands that do not perform any independent verification to confirm the accuracy of the claims they are making on the label and have no objective evidence [from third-party labs or third-party certifiers] of the truthfulness of those claims. Yet, these brands continue to make unverified claims to sell their products because they know that, when it comes to supplements, consumers cannot tell from simply looking at a product whether it contains what it claims to contain. They are banking on consumers’ implicit trust in the safety and effectiveness of supplements and their good-faith belief in the integrity of the companies selling those supplements to get away with not doing any testing or independent verification of label claims and not disclosing the fact they don’t perform any testing.

In the middle are brands that do the barest minimum required under GMPs, motivated primarily by a desire to stay under the FDA radar. While certainly better than brands that do no testing whatsoever, their testing practices rarely comply with the intent and language of GMPs. At the other end of the spectrum are brands that do what is required—nothing more, nothing less. These companies are few and far in-between and represent a minority of brands that are committed to doing what’s required under GMPs, even if there is no one to verify that they have done so. They take their obligations to ensure the safety of the supplements they distribute seriously and do their best to comply with the language and intent of GMPs.

In any case, even among the few brands that actually do any testing on their finished products, only a small fraction (less than 1% by our estimate) readily provide a Certificate of Analysis that summarizes the results of all the third-party testing performed on the products so customers can be assured that what’s claimed on the label is actually in the bottle.

At NutriGold, we go above and beyond what is required by current GMPs to independently verify that the raw materials used in our products as well as the finished products themselves meet industry-defining quality and purity standards. In fact, we have invested millions of dollars over the years into qualifying contract labs that can reliably perform the required testing using appropriate reference standards and fit-for-purpose analytical test methods. Depending on the complexity of the testing involved, including determining what needs to be tested, what methods are fit-for-purpose, and which lab is most qualified to perform the testing, we sometimes have results from as many as 4 or 5 different labs for each lot of each product that we authorize for distribution. We take the results from these third-party labs and summarize them in Certificates of Analysis, which we make freely available in the spirit of authentic transparency on the product pages on our website for customer review.

As a company powered by integrity, we give you our word that the information we make available on the product Certificate of Analysis, the information you rely on to make a purchasing decision, is accurate and truthful to the best of our knowledge and understanding. And if you still have any questions or if there is ever anything else we can do to assist you in making an informed purchasing decision, please do not hesitate to reach out to our amazing customer service team by phone at 1-800-476-3542 or via email at help@nutrigold.com.