Why the story on DS (Dietary Supplements) may be BS
This story came out about two weeks ago. I am chiming in a little late but the topic on dietary supplement manufacturing practices is still important. And you need to know about it.
According to the New York Times, GNC, Target, Walgreens, and Walmart have been caught selling mislabeled dietary supplements. Investigators found that four out of five of the products did not contain any of the herbs on their labels.
The story claims that up to 80% of pills that allegedly contain medicinal herbs contained little more than cheap fillers like powdered rice, asparagus, pulverized houseplants, and in some cases substances that could be dangerous to those with allergies.
Further, three out of six herbal products at Target — ginkgo biloba, St. John’s wort, and valerian root (a sleep aid) — tested negative for the herbs on their labels. But they did contain powdered rice, beans, peas and wild carrots. And at GNC, the agency said, pills contained unlisted ingredients used as fillers, like powdered legumes, the class of plants that includes peanuts and soybeans, a hazard for people with allergies.
Questioning the testing method – DNA bar coding
There are some problems with this report, though. It is worth noting that DNA barcoding has been criticized by botanical scientists who question whether this technology is an appropriate or validated test for determining the presence of herbal ingredients in finished botanical products.
DNA barcoding has strengths and limitations. DNA testing is rarely able to properly identify chemically complex herbal extracts as little or no DNA is extracted in many commercial extraction processes. Processing during manufacturing of botanical supplements can remove or damage DNA; therefore, while a DNA testing method can be useful in some cases, this method well may be the wrong test for these kinds of products.
Also, the DNA testing method does not provide information on the amounts of food contaminants found in the products. This is important because there are well-established legal thresholds that allow for trace amounts of some ingredients, say gluten, rice, pine, etc., which are not considered harmful or required on labels.
Alarming the public by saying that these substances could be dangerous to people with allergies is unnecessary; after all, there was no mention of whether DNA from these substances poses any allergic risk.
Being based on only one testing technology from only one laboratory, the NY AG results are preliminary and require further substantiation. Additional tests using microscopic analysis and validated chemical methods should be conducted to confirm the initial results upon which the AG is acting.
Questioning the tester – Professor James A. Schulte II
Of note, the AG’s office contracted with Prof. James A. Schulte II, PhD, of Clarkson University in Potsdam, New York, who employed DNA barcode technology to test the supplements. Dr. Schulte has a background in evolutionary biology and reptilian zoology, but he is not considered an expert in botany, pharmacology, or natural product chemistry — three key scientific areas related to herb and medicinal plant research.
The United States’ role in dietary supplement manufacturing
According to the 1994 US Dietary Supplement Health and Education Act, a nutritional supplement is defined as a product intended to supplement the diet, containing one or more dietary ingredients (including vitamins, minerals, herbs, amino acids, or other botanicals), and to be taken by mouth as a pill, capsule, tablet, or liquid.
With regards to safety: The FDA’s authority is in place to safeguard the public against an unsafe product. A dietary supplement can be removed from the market if the FDA shows that it presents “a significant or unreasonable risk of illness or injury” or that it contains “a poisonous or deleterious substance which may render it injurious to health.” The FDA can act immediately against any product that presents an “imminent hazard to public health or safety.”
Supplements are already subject to strict requirements, and the FDA has the power to inspect natural product manufacturing facilities that are required to comply with Good Manufacturing Practices (GMPs) – which require 100% of testing materials. There is no public record of GMP problems with the four claimed guilty manufacturers.
Dietary supplement manufacturers are NOT required to get approval from any agency before they can sell products. Essentially, there is an unofficial agreement that companies will follow GMP and the government will not get involved until something bad happens to a consumer or independent testing is performed.
My Take on This Story and the Manufacturing of Supplements
The whole thing sounds fishy to me. And the Attorney General’s office likely acted too quickly by labeling them guilty without a fair trial. Not only does it not make sense that 80% (way too high) of supplements tested would be mislabeled, but both the testing method and the scientist who performed the testing are suspect.
Don’t get me wrong: there are problems in the supplement manufacturing industry. Not all companies are GMP-compliant. And I rarely suggest to my patients (or anyone for that matter) that they should get supplements from Walgreens, Walmart or even GNC, because I’m simply unfamiliar with the practices of their supplement companies they carry. Also, their supplement products are too cheap, and well-manufactured supplements do not cost that little (should not be too high either).
Top-notch dietary supplement (DS) manufacturers self-police and go beyond the GMP by seeking third-party auditing of their facilities. NSF along with the American National Standards Institute (ANSI) came up with a national standard for the manufacturing of dietary supplements, which goes to the next step after the GMP’s and sets some specifications for levels of contaminants such as micro- and heavy metals-contamination and undertake voluntary certification and quality control.
I have visited four DS manufacturing facilities and use them 90% of the time when I recommend nutraceutical formulas:
- Designs For Health manufacturer of ImmunoPCTN, XYVGGR and Mr. Happy
- Douglas Labs manufacturer of CystoRenew
- Biotics Research
- Vital Nutrients
By no means is this list complete – again, these are companies I have personally investigated, and I have observed every step of the manufacturing practices.
What should you do?
- If you think the cost of a dietary supplement sounds too good to be true, it likely is.
- Supplement companies that go beyond GMP usually also have a NSF label on the bottle or on the website.
- Consumerlab.com tests some supplements (not all) for quality. You have some access to their material. For full access there is a fee.
- Integrative, Functional and Naturopathic doctors have access to high quality supplement. It’s always best to get the guidance of an expert when using these things anyway, right?