IS THE DIETARY SUPPLEMENT INDUSTRY REALLY REGULATED OR NOT?

“Snake oil,” “quackery,” and the “placebo effect” are just some of the unflattering names that the inflammatory media and even uninformed consumers have given the dietary supplement industry. Promoting this lack of confidence in nutritional supplements and making the public wonder whether supplements are really beneficial or harmful is doing a great disservice to the entire supplement industry. However, this doesn’t mean that there aren’t some nefarious manufacturers out there, looking to make an extra dollar by cheating the consumer with poorly made or even mislabeled products.

So, what’s up? Is it true that the nutritional industry is NOT regulated? The fact is that nothing could not further from the truth! The nutritional industry is, in fact, HIGHLY regulated. First, let’s take a look at the origin of this common misconception that the nutritional industry is not regulated. The dietary supplement regulations were written by the FDA (Food and Drug Administration) in 2007 and thus, they began enforcement of these regulations in 2008. These extensive regulations fall under “21 CFR 111” with the specific nutritional supplement manufacturing guidelines entitled: “Current Good Manufacturing Practices (cGMP) in the manufacturing, packaging, labeling and holding operations for dietary supplements”. 

In fact, the text of 21 CFR 111 in combination with its pre-amble section (an interpretation of the regulations) is several hundred pages long. Furthermore, the “current” portion of cGMP guidelines requires supplement manufacturers to improve on their manufacturing processes and scientific methods as those evolve in the industry which adds another layer of complexity to their regulations. 

We can see that lack of regulations regarding dietary supplements is NOT the problem … the body of the FDA regulations has been firmly in place since 2007. The problem is the lack of enforcement of these regulations by the FDA. An estimated 10,000 supplement manufacturers currently exist in the world, but only about 500 manufacturers are audited by the FDA each year. This equates to only 5% of the industry being checked each year for compliance with the FDA’s dietary supplement regulations.  

Why is this? It comes down to capacity. The FDA is able to send only about 50 FDA auditors (and associated personnel) out into the field each year to check manufacturers’ facilities. Only this limited number of  individuals is available to ensure compliance of a 50+ billion dollar industry that has been growing 6% or more a year. 

Worse yet, an estimated 20% of the supplement industry manufacturers have appeared to ignore many of the FDA’s regulations. A wise choice is to start educating yourself about the warning signs of a possible tainted or poorly made dietary supplement, and what actions you can take to ensure you are not consuming a harmful dietary supplement.

To understand how to identify a tainted supplement, you must first understand the gaps of the FDA’s regulations. Their regulations were written very broadly to encompass all the variations of how a nutritional supplement could be made. For example, a specific botanical raw material might have over 1,000 different phytochemicals (specific nutritional agents naturally contained in the plant) that may or may not have a beneficial biological effect. In addition, many different methods of processing can be used. As you can guess, depending on the methods used, a finished product with the same botanical name could have very different profiles from two different companies. 

A good example of this: two separate manufacturers who are both making the same botanical extract but using different extraction methods could end up making very different products with different ratios of active ingredients and different possible benefits, despite having the same botanical name. 

With the broad nature of the FDA’s regulations, some manufacturers have opted to perform the bare minimum of lab testing rather than following the spirit of the regulations by performing sufficient testing to ensure that their product is safe to consume. 

Here is a good example of this: the regulations require, as part of each company’s quality control program, that “at least one” lab test is performed to identify the ingredient that is used to produce a company’s particular dietary supplement.  The “at least one” phrase of the requirement was intended to mean that the company would perform as many tests as necessary to ensure their product was correctly identified … and that nothing else was present. 

However, some manufacturers have interpreted this to mean “only one” lab test is required. With so little testing, this could lead to the company’s scientists missing various contaminants that may be in the supplement -- which may have been placed in the raw material either intentionally by an unscrupulous supplier or simply due to error. 

ORTHOGONAL TESTING: THE SUPERIOR TESTING METHOD

The technique of using multiple scientific tests instead of a single test (such determining a botanical’s identity) is called orthogonal testing. An example of orthogonal testing is using these three different lab tests to confirm the identify of a botanical: 1) in tandem DNA testing, 2) microscopy (evaluation of botanical cells to identify the plant species and part of the plant), and 3) HPLC (high performance thin layer chromatography) which is a test method that looks at the active phytochemicals within a plant as a fingerprint. Together these three tests work synergistically to ensure the ingredient has been properly identified and does not contain anything else (especially undesirable “fillers” and contaminants that are increasingly more common).  Performing only one of these tests is most likely inadequate to evaluate whether contaminants are present.  

Estimates are that only 1% or less of the nutritional companies use orthogonal testing for the ingredients in their products. For the consumer, this means that they may be potentially consuming a wide array of unknown contaminants. 

CONTAMINANTS IN INGREDIENTS

At Quantum Nutrition Labs, the use orthogonal testing is required for all the ingredients used to make their nutritional supplements. With the use of this highly validated technique, the rejection rate for incoming raw material ingredients (from external suppliers) is over 70%. Wow! That means that well over half of the raw material suppliers have supplied ingredients that are NOT desirable for human consumption (for various reasons). Without orthogonal lab testing, these ingredient problems would most likely NOT be found by a company. 

Some of the contaminations identified in incoming ingredients -- that were subsequently rejected – have included lead paint, sand, and ground glass. These are all items that could potentially cause serious physical harm to a consumer.  Therefore, we believe that ensuring that a manufacturer is using orthogonal testing of ingredients as part of their quality control program is essential.

LOOK FOR THE COMPANY’S PRESTIGIOUS CGMP CERTIFICATION

Another essential procedure to ensure that a company has high quality products is an independent third-party cGMP certification. Third party certifications are not required by 21 CFR 111 but can help consumers to easily identify companies who are achieving baseline cGMP requirements as well as higher standards. 

Quantum Nutrition Labs ensures their products meet higher standards, above and beyond what is required by the law, with their requirement that the manufacturing process used to make their supplements is United States Pharmacopeia (USP) cGMP certified.  USP is a independent non-profit organization that sets standards for testing and manufacturing for Food ingredients, Medicine, and Supplements. Established over 200 years ago, it has been the gold standard for manufacturers. 

USP requirements for manufacturing nutritional supplements go beyond the FDA’s 21 CFR 111 guidelines. Because of USP’s stricter and more extensive requirements, only a handful of supplement manufacturers in the world have obtained this prestigious certification. This stringent requirement is one of the reasons Quantum Nutrition Labs chose USP as the requirement for the manufacturing process. As consumer, if you find that a nutritional supplement does not have a third-party certification, you should be cautious of the quality of the supplement.

RED FLAGS TO WATCH FOR

Going beyond these ideal standards and requirements of testing and manufacturing of a supplement, consumers should be aware of some red flags when they are viewing a dietary supplement label. 

1.) Every bottle of a dietary supplement must have a name of the company distributing or manufacturing the supplement which also includes the address. This is to ensure that the consumer can contact the company if there is a complaint, or a physical harm caused by the supplement. 

2.) Every dietary supplement is not allowed to make what the FDA calls “disease” claims. If you see a supplement that claims to cure cancer or cure COVID-19, the FDA views this as an illegal claim and thus, an illegal product. You should immediately be suspicious of the quality and integrity of the company. 

3.) Finally, every supplement is required to have a Supplement Facts panel where the ingredients are identified. If this is missing on a bottle, the consumer should be cautious of the quality of the supplement.

WISELY SELECT YOUR NUTRITIONAL PRODUCTS

In 1994, an estimated 4,000 supplements were available to consumers. Today, an estimated 90,000 supplements are in the marketplace. With the continued growth of the nutritional industry, there will always be manufacturers that are looking to take advantage of the system with inferior products. 

However, other manufacturers have chosen to lead with values of integrity, transparency, and quality without compromise such as Quantum Nutrition Labs. As a consumer, it is necessary for you to verify the manufacturer’s integrity. Have they made the choice to go above and beyond the requirements of the law in producing their products? At the end of the day, you are the one who must look at a supplement and ask yourself the question: “Is this going to give me and my family our best health?”