Are Vitamins and Supplements Safe?
With more consumers relying on dietary supplements to address growing health concerns, it’s more important than ever for practitioners — and their patients — to understand the factors driving quality so they can know what to look for, and what to avoid. Knowing more about dietary supplements, how they’re regulated, and who is charged with monitoring manufacturers can go a long way toward finding the safest and most proven products. The process is no different from how you’d evaluate medications.
There are a few myths about supplements and regulation, so let’s debunk them and get to the bottom of the question at hand: are vitamins and supplements safe?
Are Supplements Regulated?
There’s a rather popular myth that vitamins and supplements aren’t regulated. People say it all the time — even people who should know better (like some who work in the medical field) spread this rumor, saying it as if it were a fact.
However, we can say with certainty that this myth is just that — a myth. It’s simply not true.
The all supplements. The confusion likely stems from the fact that the FDA does not regulate them in the same way as they do prescription drugs. Instead, they’re regulated as food, because they’re intended to supplement people’s diets.
Furthermore, there are provided by the FDA that require manufacturers to produce dietary supplements in a safe, quality manner, ensure that they don’t contain contaminants or impurities, and restrict the way supplement manufacturers can market and label their products.
For example, all dietary supplements must be labeled as such, and they cannot make specific health claims that are not pre-approved by the FDA. The that “Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. That means supplements should not make claims, such as ‘reduces pain’ or ‘treats heart disease.’ Claims like these can only legitimately be made for drugs, not dietary supplements.”
All that being said, there have been some negative stories in the media about the integrity of supplements on store shelves, which has increased the level of skepticism surrounding dietary supplements.
The good news is that there are purity and safety standards in place — not just from the federal government, but from independent third parties as well. These supplement standards are specifically designed to maintain the potency, safety and integrity of ingredients, as well as to prevent potential contamination or adulteration.
Supplement Standards
First of all, supplement manufacturers must follow the same strict guidelines that food manufacturers have to follow (remember that supplements are regulated as a food supplement, not as a prescription medication). Specifically, they must follow regulations in the Dietary Supplement Health and Education Act of 1994 (DSHEA):
“Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.”
After a supplement hits the market, the FDA has the authority to take action against any company that appears to not be fulfilling their obligations, either by misrepresenting their product, or by making claims they cannot legally make.
Secondly, there are purity and safety standards for dietary supplements to ensure that what people are purchasing is what it claims to be (i.e., it’s actually magnesium in the magnesium supplement), and has no microbial contamination.
Potency and Purity Standards
Important markers of a quality nutritional supplement are its potency and purity. A critical factor for both practitioners and patients is that the bottle contains exactly what the label says it does. Reputable manufacturers with good quality processes test all the ingredients they order for correct identity, potency and purity upon receipt, before they ever accept them into their warehouses to be used for supplement production.
They test these raw ingredients for heavy metals, pesticides, solvents and microbial contamination to ensure they meet safety and purity specifications before ever being used in the manufacturing process. Then, they test the finished product again to ensure all the same safety and purity standards are met in the finished product before being released for sale to the consumer.
While many supplement manufacturers are vigilant about their quality and purity standards and careful about making sure their supplements contain no contaminants, that’s not necessarily the case for every company. As with any other for-profit industry, there will always be someone cutting corners.
Safety Standards
DSHEA was enacted to protect public safety by assuring that products offered in grocery stores, health food stores, and community pharmacies would do no harm. A manufacturer following the DSHEA safety standards is using ingredients generally recognized to be safe and effective for their intended use, and ensuring the safety and purity of the product throughout the entire manufacturing, packaging and shipping processes. By doing research on the company, you may be able to determine if they’re meeting the requirements set forth by this legislation. If they’re not, the FDA may have sent them warning letters, which are accessible on the .
In addition to the FDA and DSHEA regulations, there are multiple agencies that monitor the safety of manufacturing practices for nutritional supplements. The National Institute of Standards and Technology (NIST) operates under the U.S. Department of Commerce, and the Office of Dietary Supplements (ODS) operates within the National Institutes of Health (NIH).
The National Sanitation Foundation (NSF) and the U.S. Pharmacopeial Convention (USP) are well-known companies that provide guidance and oversight for supplement manufacturers all the way from production to packaging. NSF and USP look for adherence to (cGMP), which the FDA has the power to enforce.
If a given manufacturer has passed the inspections and requirements set forth by any of these agencies, they’re likely to have a special seal placed on their website, and perhaps even the supplement bottles themselves. This is information you could learn by researching the company.
Voluntary Product Testing
Some companies take this even one step further by utilizing voluntary product testing. We’re proud to say that Emerson Ecologics is one of those companies. We’ve been dedicated to safety and quality from day one. We created the (EQP)® for the purpose of helping practitioners make more informed decisions about which supplement brands they’d recommend to their patients.
Brands that wish to participate in the EQP® must submit an application that details their current manufacturing processes — which must meet cGMP standards — and product testing in both raw and final form. If the Emerson Ecologics quality department finds that all documentation is in order and follows necessary protocols, they perform additional product testing through an independent lab, and conduct a day-long on-site audit of the manufacturer. To ensure that all brands in the program are maintaining , we re-evaluate each brand every three years.
And for our part on the distribution side, we work tirelessly to ensure that all of our distribution facilities are NSF certified and cGMP compliant. We receive our product directly from the manufacturer, and keep it stored under strict temperature control and sanitary conditions. What that means for you and your patients is fresh, potent and effective products.
How to Choose Vitamin and Supplement Brands
Do Your Own Research
The best way to ensure the supplements you’re recommending to your patients are up to the highest possible standards is to be vigilant on your own. Research the brands you’re considering, ask for input from your own colleagues, and read what other integrative practitioners have to say about each brand.
“I like to focus on the quality and integrity of the company making the products before I recommend them to my patients,” says , a Family Medicine Physician practicing Functional and Integrative Medicine in Scottsdale, Arizona, and member of the Emerson Ecologics Medical Advisory Board.
“The best companies carefully source their ingredients and test the raw materials before incorporating them into a product. They then test the compatibility of the ingredients they intend to combine and test or calculate how long it will maintain its potency. Even more importantly, they test for metals and other toxins that might find their way into the raw materials and then into the finished product.”
Following Sheeler’s advice, practitioners should really start with the brands and the safety measures they’re taking. “The really good companies have very tight quality control processes for ensuring that everything they produce meets the highest standards of purity and safety.”
Read the Label
If you’re discussing food products with your patients, you’re probably recommending that they read the labels. What are the ingredients? In what order are they listed? If the product claims to be organic, is it certified by any specific agency (such as the USDA)?
The same advice should be given with regards to nutritional supplements. The label is quite important because it speaks to the regulations the company is following. Look for USP or NSF seals. On the Emerson Ecologics website, you can also look for the Gold or Silver seal for the EQP®.
puts a lot of faith in the . “A product that contains this seal of approval has been shown to 1) be manufactured using FDA Good Manufacturing Practices, 2) contain what is stated on the label, 3) is free of known potential harmful contaminants, and 4) will actually release the active ingredient from the product for absorption into the body,” he says.
You Get What You Pay For
One important rule of thumb to mention to your patients is that quality is worth the price. “I have a number of patients who want to shop for their vitamins and supplements at the cheapest prices,” says Sheeler. “They want to ‘get a good deal’ on their supplements and rate the quality of their experience by how much of a discount they get off of a name brand. They definitely don’t want anything with a proprietary ingredient if they can help it.”
But Sheeler believes that’s “just a bad idea. Having practiced Integrative and Functional Medicine and having led the design of a number of products I know that there are a lot of ways corners can be cut and a lot of things that can go wrong. I’ve always advocated for the high road with thoroughly tested high quality ingredients. I like to say that the only thing worse than not knowing what can go wrong is knowing — it makes you worry a lot more about what goes into something.”
While cost is a factor for many people, patients must understand the risks of choosing a supplement brand that may have lower potency, be less effective, or may even be adulterated and unsafe. For Sheeler, the safety and quality of the product far outweighs the potentially higher cost.
“They might or might not cost a bit more but the peace of mind I get knowing that they have done everything to get the exact right ingredients in their purest form into every batch of every product they make is what sets the great brands apart from the discount brands,” says Sheeler.
Helping Practitioners Choose Quality
When patients ask about nutritional supplements, they want to know that they’re safe, effective, and that they’re worth the money. While FDA regulations can’t guarantee those things, we’ve gone to great lengths to make sure that we’re helping practitioners get closer to being able to make those assurances.
As previously stated, the EQP® was designed to assist practitioners in making more informed decisions when recommending quality dietary supplements to their patients. Furthermore, we want practitioners to be able to assure their patients that they’re doing everything they can to take good care of them. If you’re interested in learning more about our Wellevate platform or the Emerson Quality Program®, get in touch with us today!
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