Before reading the rest of this post, go to your vitamins and supplements and look for this label (just the letters “USP” don’t count, you have to see this exact mark):
The United States Pharmacopeia (USP) is a private, nonprofit organization that publishes the official pharmacopeia for drugs (both prescription and over-the-counter), food additives, and dietary supplements. A pharmacopeia is a document that describes what’s in or how to make a drug.
The USP, which came into being in 1820, predated the Food and Drug Administration (FDA) by 86 years. To this day, FDA continues to depend on, and enforce, USP standards. Those standards ensure products are of the correct identity, strength, quality, purity, and consistency. The buck stops with the USP when it comes to identifying a drug.
Prescription drugs are required to meet USP standards, dietary supplements are not. (USP, White Paper, Access To Good Quality Dietary Supplements, September 2009.) Two other bits of data from that White Paper:
“Manufacturers set their own limits for contaminants such as heavy metals, microbial limits, fungal toxins, or pesticides.”
“Under the current law and regulations, there is no way of knowing the quality standards to which each product is held, and thus, there is no way to determine whether two products with the same dietary supplement ingredients are the same or different.”
That is why the 30 top-selling fish oil supplements all contain mercury, some at levels above the maximum set by the EPA for drinking water. Manufacturers can set their own limits.
Fortunately, the USP conducts a verification program for dietary supplements. Unfortunately, the program is voluntary and not widely used by the supplement industry:
[USP] awards the use of a distinctive USP Verified Mark for dietary supplements to products that meet the program’s rigorous standards. The distinctive USP Verified Mark on a dietary supplement product is intended to assure consumers, healthcare practitioners, and pharmacists that the product:
- Contains the ingredients stated on the label in the declared amount and strength
- Is within limits for contaminants such as heavy metals, pesticides, and microbes
- Will disintegrate or dissolve as per USP’s requirements, where applicable, to release nutrients for absorption into the body
- Has been manufactured using well-documented and controlled procedures in accordance with Good Manufacturing Practices (GMPs)
Back to that task at the top of this post … Did you find the USP Verified mark? I’ll bet you didn’t. According to Dr. Paul Offit, chief of Infectious Diseases at CHOP (Children’s Hospital of Philadelphia, which just, controversially, removed almost all dietary supplements from its list of approved medications) only “0.001 percent” of supplements are USP-verified. That means your supplements may not contain what the label says they contain (i.e. do not meet USP standards for identity, strength, quality, and purity). If they did, why wouldn’t the manufacturer seek to obtain use of the mark?
I can’t believe that a wholesale club like BJ’s has an inexpensive house brand (Berkley&Jensen) that includes USP verified products but a high end supplement like Twinlab does not (even though they refer to “USP” on their labels). See List of USP Certified Dietary Supplements.
Nature Made is on the USP-verified list:
From Wikipedia: “Products that meet the requirements of the program can display the USP Verified Dietary Supplement Mark on their labels. This is different from seeing the letters “USP” alone on a dietary supplement label, which means that the manufacturer is claiming to adhere to USP standards. USP does not test such products as it does with USP Verified products.”
By the way, USP requires:
“Care shall be taken not to state or imply that the USP Verified Mark indicates that USP endorses the safety or efficacy of the product.”
USP ensures the identity, strength, quality, and purity of a drug, but it doesn’t ensure safety, and it makes no comment about whether a supplement does what it says it can do. That falls under FDA, but there’s no pre-market enforcement as there is with prescription drugs.
We demand fresh, organic, locally-grown, minimally processed, uncontaminated food, but we toss those standards to the wind when it comes to supplements – opting for stale, non-organic (pesticides), genetically modified, imported, ultra-processed pills with no assurance of potency, purity, efficacy or safety.
US Dietary Supplement Verification Program (pdf)
USP Verified Dietary Supplements, USP Resource Page
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