Public Health Topics

Safety Considerations When Supplementing the Plant-Based Diet

Vegans have been made well aware that, despite great attempts to eat a variety of powerhouse plant foods, supplementation may be necessary to ensure adequate intake of various micronutrients. Luckily, resources outlining why and how much of some vitamin and mineral supplements may be beneficial for vegans are not lacking. Many common questions vegans have about dietary supplements are easily answered, such as how to identify animal-derived ingredients in consumer products, the role of vitamin B12, what types of vegan protein powders are recommended, and whether plant-based athletes should take sport supplements for improved performance. There is no doubt that dietary supplement options are overflowing on the market, making it understandably challenging to choose a product that best fits the needs of the plant-based consumer.

Unfortunately, there is one key subject lacking among resources for vegans when considering what dietary supplements to purchase: safety. It should be noted that many dietary supplement companies may far exceed federal requirements for quality and safety in their products- the unsung heroes of the industry, you might say. Nonetheless, it is important for consumers to understand safety risks involved with consuming dietary supplements and be knowledgeable of the best ways to avoid them.

So, how do you protect yourself?

 

Don’t assume that more is always better.

Just as higher cost doesn’t always equal a better product, taking high doses of extra vitamins and minerals doesn’t always equate to better nutritional “insurance”. Plant-based diets can be planned well enough to cover nearly all the bases, especially when they include fortified foods, often making a daily multivitamin overkill in attempt to meet nutritional needs for the average person. Therefore, it is important to identify areas of potential imbalance so that these specific nutrients can be targeted. This can be done with the assistance of your healthcare team, including a registered dietitian, and it may be beneficial to have blood work evaluated for deficiencies.

 

Understand how dietary supplements are regulated.

Dietary supplements are regulated differently than pharmaceuticals or foods. Although manufacturers are required to register their facilities with FDA, they do not have to obtain FDA prior approval to make or sell products. That said, FDA requires dietary supplement manufacturers to adhere to strict regulations. All dietary supplement manufacturers, distributors, and packagers must follow Good Manufacturing Practices for dietary supplements under FDA’s 21 CFR 111 regulation. Manufacturers are responsible for ensuring that all product label claims are accurate and for reporting any serious adverse events found to be associated with use of these products in the United States. Adverse events can be reported through FDA or Natural Medicines Watch. Once a supplement is on the market, FDA monitors reported adverse events (and takes necessary action such as issuing a warning or requiring a product recall) and regulates product labels and packaging literature, while FTC regulates product advertising.

 

Understand what Good Manufacturing Practices (GMPs) are.

Per FDA’s 21 CFR 111 regulation, it is federal law that dietary supplement manufacturers, packagers, labelers and distributors adhere to GMPs, meaning they meet certain industry quality standards. FDA itself does not certify dietary supplement products or the facilities in which they are made, and it is important to note that there is no official GMP seal to look for on products that indicates verified company GMP compliance.

 

Be aware of specific product safety concerns and don’t assume that “natural” means safe.

Though the majority of dietary supplement manufacturers work very hard to ensure the quality and safety of their products, it is important for consumers to be aware that adulteration and contamination of products still pose a tangible risk.

Many botanical ingredients used in the manufacturing of supplements are sourced from countries outside of the United States. There is concern that, if these ingredients are not handled and tested properly by the manufacturer, consumers can unknowingly ingest supplements contaminated with unsafe levels of substances like lead, arsenic, mercury, pesticides, microbiological contaminants, bacteria, fungi and mold, among other harmful residues.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) denotes that a supplement is considered adulterated “if it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.” Awareness of substances banned by the World Anti-Doping Agency is especially important for athletes looking for sports supplements, as many of these substances have been linked to adverse events, including death. One resource is the United States Anti-Doping Agency’s Supplement 411 High Risk List for dietary supplements, which outlines product examples that pose a high risk for containing prohibited substances. Since 2012, the Human Performance Resource Center (HPRC) has also been keeping a list of currently available dietary supplements that contain DMAA, an illegal ingredient that can increase blood pressure and cause a heart attack.

The FDA Consumer Updates page is another resource for current news in supplement safety.

 

Read the label.

FDA requires all dietary supplements to have a Supplement Facts panel (this differs from a Nutrition Facts panel on food products), which includes the name of the product, how much is in the package, who manufactured/packaged/distributed the product, its ingredients, and the nutritional constituents. Manufacturers may also list “proprietary blend” on their label, indicating a mixture of ingredients, often making it impossible to know what exactly is encompassed. The HPRC has created resources to help consumers choose safer supplements, such as a label checklist and a red flag checklist.

 

Look for third-party testing marks.

Perhaps the most important thing to remember is that, though dietary supplements is a regulated industry, there is no FDA seal of approval to indicate verified product safety. The best way to ensure that you have chosen a safer supplement is to look for one that has been tested for quality and safety by a third-party certifying body.

According to the United States Anti-Doping Agency (USADA), a dietary supplement third-party testing agency should:

  1. Be free from conflicts of interest.
  2. Have external accreditation such as ISO Guide 65- General Requirements for Bodies Operating Product Certification Systems or equivalent, and ISO17025 – General Requirements for the Competence of Testing and Calibration Laboratories.
  3. Conduct an audit of the supplement company to Good Manufacturing Practice (CFR 111). The third-party testing company (or another vendor if this step is outsourced) should offer proof of qualifications to conduct the audit.
  4. Evaluate the dietary supplement for overall safety and quality (preferably according to NSF/ANSI 173 Dietary Supplements).
  5. Have validated and accredited methods to test for prohibited substances in sport.

The HPRC has identified some of the most well-known third party marks for dietary supplements below.

Supplement Third Party Logos

Image source: Human Performance Resource Center (HPRC)

 

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