Dietary Supplement Quality | Fullscript | Fullscript

Dietary Supplement Quality: Research, Procedures, and Certifications

The term “quality” is tossed around so much that it has almost lost its meaning. And yet, when it comes to purchasing and recommending dietary supplement ingredients, there is nothing more important than quality. But what constitutes a high-quality product? As it turns out, discerning dietary supplement quality is a complex, multi-layered process that requires detailed information about every aspect of the dietary supplement supply chain. Fortunately, there are rules and guidelines in place to make sure that dietary supplements are manufactured properly, labeled clearly, and safe for human consumption.

Not all supplements are created equal and ingredients can vary from product to product.

An introduction to dietary supplement quality

A great place to start the quality conversation is by looking at why quality is important to you, your practice, and your patients. While this may seem obvious, it’s worth asking yourself this question and then making the answer a key tenet of your clinic.

For naturopathic oncologist, Tina Kaczor, ND, FABNO, quality dietary supplements help inform her about the efficacy of her clinical protocols.

“For example, if I use L-theanine for a patient who is having difficulty focusing, I expect the patient to have improved concentration,” she explains. “And if the patient uses a lesser quality L-theanine brand, I won’t know if the problem is with the inferior product or if I should recommend a different intervention.”

Quality helps Dr. Kaczor determine what’s working and what’s not, so she can achieve the best possible health outcomes for her patients, which is a key tenet of her clinical practice.

Integrative family physician Jeffrey Gladd, MD, agrees that efficacy is key, and utilizing high-quality products can lead to much better outcomes.

“I’ve had many patients who are not feeling well and when I switch their dietary supplements to the high-quality brands, they immediately feel better,” he says.

Both he and Dr. Kaczor feel that utilizing lower quality products can lead to poor outcomes but it may also negatively impact the patient’s health.

“When I recommend a high-quality brand, I feel more confident that my patients will get the expected benefits, and the potential for side effects or reactions will be minimized,” said Dr. Gladd.

It’s clear that efficacy and safety are two key drivers when it comes to focusing on quality dietary supplement products. The next step is to clearly communicate this to patients.

Doctor as teacher

The practitioner’s role is to not only choose and recommend high-quality dietary supplements, but it’s also to educate patients about quality. One of the principles of naturopathic medicine is the concept of docere, the Latin word that means “to teach.” The integrative physician puts this concept into action by educating patients, not only about making healthy diet and lifestyle choices but also about choosing quality products.

“Especially when the cost comes up, I explain to my patients that there are multiple ways that companies control the quality of their products and it costs money to employ these critical quality measures,” explains Dr. Kaczor. “I talk to my patients about certification, testing, and other quality aspects so they understand why it’s important to use dietary supplements from reputable manufacturers.”

The pitfalls of third-party purchases

Typically, a discussion about quality dietary supplements may also bring up the issue of online third-party sellers, where cost can be a factor. Both Dr. Kaczor and Dr. Gladd offer significant discounts to patients to encourage them to utilize higher quality brands and discourage them from third-party purchasing.

Several quality issues can arise when patients buy dietary supplements from third-party sellers such as Amazon and eBay including:

“Because of significant quality concerns, buying dietary supplements from Amazon is a scary proposition for patients,” says Dr. Gladd.

Integrative medicine expert Ronald Hoffman, MD, concurs.

“As big as Amazon is, they don’t vet the quality of these dietary supplements or have any organized medical oversight of the supplement products they are selling,” Dr. Hoffman explained.

One way that healthcare practitioners can help ensure they are purchasing a high-quality product is by interacting directly with the manufacturer. That’s another quality aspect that’s missing when purchases are made through a third-party seller—no direct interaction with the manufacturer.

Buyer beware

Dr. Kaczor illustrates the importance of being diligent when buying and recommending even high-quality products. “Several years ago, a highly reputable enzyme company could not get an important raw ingredient for their flagship product, which was a pain reliever. As a result, it was off the market for a while. During that time, someone duplicated the label and made tablets that looked similar and started selling the fraudulent product as if it were authentic. Dr. Kaczor goes on to say, “As an interesting aside, enzymes containing protease are easily tested because they irritate the tongue. So, at the time, I broke open both tablets to do my own test. The authentic enzyme brand burnt my tongue for hours after contact and the knock off did nothing.”

This emphasizes that buying from reputable suppliers is absolutely critical. Even well-known retailers can be problematic as illustrated by a 2015 claim that four national retailers—GNC, Target, Walgreens, and Walmart—were accused of selling fake and potentially harmful herbal supplements.

Interacting with manufacturers

Finding quality dietary supplement products begins with a conversation with the manufacturer and then progresses from there.

Lori Bestervelt, PhD, who was Executive Vice President and Chief Science Officer with NSF International and directed the NSF Standards Development and Toxicology Services Department, says “I think it’s important to ask a lot of questions up front because the quality of the finished product starts with the quality of the raw materials and the manufacturing facilities.”

When it comes to questions to ask, healthcare practitioners should focus on these key areas:

It can also be helpful and eye-opening to tour the facility including the lab where on-site testing takes place. Strict testing procedures should be in place to ensure purity, safety, and efficacy.

Regulating dietary supplements

In Canada, dietary supplements are regulated by Health Canada under the Natural and Non-prescription Health Products Directorate (NNHPD), which mandates that every Natural Health Product be registered for a Natural Product Number (NPN) prior to entering the market.

In the United States, the Federal Food and Drug Administration (FDA) has established guidelines to help manufacturers produce quality products. According to the FDA, quality is reflected when a dietary supplement consistently meets established certifications for identity, purity, strength, and composition, while limiting adulteration and contamination.

In 1994, Congress established the Dietary Supplement Health and Education Act (DSHEA) which gave dietary supplements a special classification of regulation within the food category that is separate and distinct from pharmaceuticals.

With the passage of DSHEA, a new regulatory framework for labeling and safety was created. Dietary supplements were never regulated in the same fashion as pharmaceuticals and now with DSHEA, they are no longer regulated as foods. With their special classification within the food category, manufacturers are strictly prohibited from marketing supplement products that are unsafe or contain an unsafe ingredient.

Pharmaceuticals versus supplements

Because of the implied safety profile of dietary supplements that contain vitamins, minerals, amino acids, herbs, and other natural substances, they are not regulated as strictly as pharmaceutical drugs. Prior to market release, pharmaceuticals need FDA approval on parameters of safety, efficacy, manufacturing compliance, labeling/packaging, prescribing information, and marketing materials.

Dr. Bestervelt explains the regulatory difference between dietary supplements and drugs this way: “Dietary supplements are considered safe until proven otherwise, whereas drugs are considered unsafe until proven safe through clinical trials.”

New dietary supplement ingredients

If an ingredient was not marketed in the United States prior to October 15, 1994, it is considered a New Dietary Ingredient (NDI) that requires special FDA notification at least 75 days prior to being released into the marketplace.

The importance of cGMPs

All domestic and foreign companies that manufacture, package, label, or hold dietary supplements for sale in the United States must follow the FDA’s cGMP guidelines—it’s the law.

These companies must also register with the FDA, which makes their facilities subject to FDA inspections. Foreign suppliers also have specific requirements.

What cGMPs cover

The cGMPs established by the FDA are incredibly comprehensive and detailed. Here are examples of what is included in the cGMPs:

Foreign supplier requirements

The FDA requires importers of dietary supplements to develop Foreign Supplier Verification Programs (FSVP) for each product imported to ensure the foreign suppliers meet U.S. safety standards.

Identification and validation of ingredients

The finished product is only as good as the starting material. That’s why proper identification and validation of all ingredients is critical. And that process begins with ingredient sourcing.

Allergen and source claims

Accurate dietary supplement labeling is a big part of the FDA-established cGMPs. When it comes to dietary supplement safety, labeling of allergens and claims related to the sourcing of ingredients is critical because it reduces the risk of allergic reactions and unintentional consumption of dietary restricted items.

Understanding excipients

In addition to full disclosure regarding allergens and ingredient sources, excipients can also impact the buying and prescribing decision, so full label transparency is required by the manufacturer.

Examples of the various types of natural excipients include:

Common synthetic excipients include cellulose, dyes, magnesium stearate, parabens, and silicon dioxide.

Supply chain scrutiny

Transparency is a key characteristic of an effective quality control program. This requires manufacturers to provide a clear picture of every step of the supply chain.

Key testing procedures and third-party certifications

Third-party certification companies are independent auditing agencies that inspect and verify ingredient sourcing, product manufacturing standards, distribution channels, and accurate labeling. Utilizing these companies is completely voluntary by the manufacturer.

Appreciating the role of research

Of course, before a product is even a product, there is an idea that an ingredient or group of ingredients will somehow enhance health. That’s where research comes in.

Environmental and social considerations

Many healthcare practitioners and their patients are socially-minded buyers so a manufacturer that focuses on the environment will likely be deemed a higher quality company.

Making quality a priority

When it comes to dietary supplements, embracing quality is easy. Evaluating it is not. That’s why taking a comprehensive supply chain snapshot for each individual manufacturer you are considering is critical.

The bottom line

There are many considerations to make when purchasing and recommending supplements. The following is a review of what was covered in this article. You can use this checklist when evaluating suppliers.