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Combating a Tainted Market: 3 Ways to Substantiate a Dietary Supplement Product

Three out of every four Americans consume some form of a dietary supplement regularly, and as Americans get older, this rate increases. As intake increases the number of products on the market deepens and the list of potentially adulterated products grows. The FDA’s adulterated product directory has more than 776 dietary supplements identified as containing at least one unapproved ingredient from 2007 – 2016.

As media attention increases around the risk of “bad” products on the market, consumers are becoming increasingly wary of the presence of potentially harmful, misbranded dietary supplements. If this trend continues, we predict that customers will not only become more selective when buying products, but that overall trust in the industry will begin to weaken.  

So, how can dietary supplement companies selling legitimate products ensure they aren’t looped in with the bad apples?

1. Trademarked Ingredients

One way to improve the quality of your product is to improve the quality of your ingredients, which can be done by including trademarked ingredients in your formulation. Using highly specialized, proprietary ingredients can help ensure the quality and efficacy of your product because these ingredients are generally (1) backed by science, (2) controlled for quality and (3) specially sourced. The differences between trademarked ingredients and others offer a form of insurance that the ingredient listed on the label is indeed the ingredient in the bottle.

Consider the ingredient curcumin, a polyphenol known for its anti-inflammatory properties and ability to maintain overall health. The longstanding challenge with this ingredient deals with the body’s ability (or inability rather) to absorb curcumin to receive its full range of benefits.

Enter a bioavailable curcumin extract that has clinical research to prove it delivers about seven-times the amount of bioactive curcumin into the bloodstream. Not only does this product have science to back it up, but the producer of BCM-95 Biocurcumin® incorporates more of the turmeric plant, where curcumin comes from, and touts a 100-percent natural product with no artificial additives. The point is: this product is highly scrutinized to guarantee its efficacy and quality, unlike cheaper products on the market. 

2. Third Party Testing

Since supplements are regulated in a post-market manner, The FDA doesn’t really know whether what is in a product’s capsules reflects what is on the product label; the FDA relies on manufacturers to regulate the product in pre-market stages. The best-in-class approach for dietary supplement companies to do this is through third-party testing to ensure products are free from contaminants and to guarantee the label accurately represents the formulation in the bottle. For instance, in an effort to combat what it calls an under-regulated industry, the drugstore CVS just announced it will only sell supplements at its stores that have been third-party tested and approved.

There are different types and stages of third-party testing:

  1. Material testing – the raw materials sourced in the manufacturing of the supplement are tested for their strength, purity, and identity.
  2. Batch testing – batches of the finished product are tested against product specifications; each batch goes through quality, safety, and stability inspections. In this stage, ingredients found on the supplements facts panel (SFP) must also appear on the final product.
  3. Stability testing – products tested to ensure that unforeseen contamination or expiration does not occur during the supplement’s life cycle. Testing can be performed on 6, 12, 18, and 24-month intervals, again authenticating the product specifications throughout the supplement’s shelf life.

Upon completion of testing, a certification of analysis (COA) is constructed, fundamentally signaling the product has substantiated its predetermined product release specification(s).  Many companies put seals on their labels to indicate third-party testing, however, it is important that sourcing information is made available so that consumers can readily authenticate how the testing was carried out.

3. Doctor Recommended Claims

Consumers are advised (via FDA, NCBI, etc.) to consult a doctor before consuming dietary supplements, as often products make unjustified claims about their intended benefits. Dietary supplements cannot make therapeutic claims tied to a disease or medical condition and are limited to structure/function claims to describe the role of an ingredient. Structure/function claims detail a dietary ingredient or nutrient’s affect on the “…normal structure or function of the human body.”

Many dietary supplement companies turn to doctor recommended claims as a means of representing the products’ potential medical benefit. However, these claims are not always substantiated in a manner that is compliant with FDA/FTC guidelines. If you have a claim boasting a “#1 Doctor Recommended Brand,”  there must be evidence to back up the claim, which requires an expertly-conducted, randomized, and statistically significant survey of doctors in the relevant practice area showing that a substantial percentage of those doctors recommend the product. Moreover, their conclusions should be based on their real experience and what they recommend in their daily practice.

Conclusion:

We’ve now discussed three viable methods to guarantee a quality product, but all of this, of course, comes with a cost. The more resources invested in proving a product’s value likely translates to a higher price point. In our next piece, we’ll talk about practical ways to effectively educate the consumer on these investments in an effort to justify the premium price.