For over a year now, CNCA has had trouble keeping its Curcumin Pro supplement in stock due to a global shortage of “clean” curcumin. By “clean” we mean free of the solvent EDC (1,2 dichloro-ethane), a USP Class 1 solvent and known carcinogen. The USP (U.S. Pharmacopeia) limit is 10ppm (parts per million). Yet in recent months CNCA has rejected three lots of raw curcumin containing as much as 4200 and 7110ppm. And even at the lower level of 9ppm in one lot, a daily dose would exceed the California Prop. 65 limit for carcinogens. At times, lack of safe raw curcumin has forced CNCA to place Curcumin Pro on backorder.
But there’s much more to this story than just a supply shortage. It’s a cautionary tale that illustrates how supplement quality is based on one simple concept: You only find what you look (test) for. And unfortunately, too many manufacturers aren’t looking hard enough for dangerous contaminants like EDC in their raw ingredients.
First, it’s important to understand that most raw ingredients can contain natural and man-made contaminants that are introduced before or during processing. In the case of curcumin, solvents are used to extract curcumin from the spice turmeric. The turmeric itself could have been exposed to lead in the soil or herbicides, pesticides or fungicides used in farming operations. Contaminants can also be introduced during the supplement manufacturing process.
As with any industry, there are regulations in place to help protect consumers from harmful contaminants as well as other quality issues. But, as you’ll see, these standards are only a place to start.
Industry Regulations
There are two sets of standards designed to protect you—those set by the FDA and its cGMPs (Current Good Manufacturing Practices for Dietary Supplements) and the U.S. Pharmacopeia (USP).
The FDA requires that for each supplement a manufacture produces, it must establish product specifications for the identity, purity, strength, and composition of the finished product. The manufacturer must also establish limits on the types of contamination that may adulterate, or that may lead to adulteration of the product to ensure quality. The manufacturer is expected to test for any contaminants that can be reasonably expected to occur in the particular raw material.
If you read the previous paragraph carefully, you noticed that it’s rather vague and leaves it up to the manufacturer to define “purity” and what that means--what tests to perform to prove it.
But the FDA also maintains a relationship with the USP, an independent, non-profit standards-setting organization that publishes two reference books of standards that are enforced by the FDA: The United States Pharmacopeia and The National Formulary. Working with manufacturers, the USP standards delineate the appropriate tests, procedures and acceptance criteria (the specifications) for each product. While the USP standards help “fill in” some of these gaps and grey areas in the FDA cGMPs, quality problems still exist.
Suppliers
As mentioned earlier, many raw ingredients used in supplements undergo a refining or extraction process by the supplier. The supplier is required to provide a Certificate of Analysis (COA) which identifies, among other things, the product’s identity and any solvents used in its production.
In an effort to increase profit margins, some suppliers may use a less expensive but dangerous solvent, such as EDC, rather than a more expensive but safer option.
In the case of curcumin, other safer solvents such as ethanol, acetone, or ethyl acetate could--and should--have been used. Per USP standards, EDC should only be used when it’s unavoidable and its use reported and quantified in the COA.
Unethical suppliers have also been known to provide incomplete solvent residue data on the COA—or omit it altogether. For example, a supplier may list the solvent as acetone (a Class 3 solvent generally considered safe), when they had used EDC. Without disclosure, a manufacturer following current standards would not be required to test for EDC and could potentially manufacture and market supplements containing carcinogens.
Manufacturers
As you can see, following the minimum standards set by the FDA and USP is not enough to protect consumers, manufacturers must take it upon themselves to go beyond what is required, and many ethical, quality conscious manufacturers like CNCA have done just that. (The challenge for consumers is figuring out which ones are going the extra mile, but more on that later.)
So while many supplement brands following FDA or USP standards conduct fewer than 50 tests, CNCA conducts over three times as many or up to over 200 tests on raw ingredients and finished goods. Why all those tests? Because you only find what you look for. That’s how we learned about EDC solvent contamination over ten years ago and began working with other industry groups like the American Botanical Council to address the problem.
Unfortunately, EDC is just one of many harmful contaminants that regularly escape detection by some manufacturers that limit their testing to only what the FDA or USP standards require.
Consumers
In a perfect world, consumers wouldn’t have to worry about the safety of their products as everyone involved in their manufacture would just do the right thing. Until that day comes, consumers will have to do their homework and ask the right questions to ensure their products are thoroughly tested and as safe as possible.
We work very hard to earn your trust because at the end of the day, our reputation for expert nutrition and exceptional quality is all we have.
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