We humans have been taking supplements for almost 200 years - and we’re hooked.
In 2022, the global nutritional supplements market was worth an estimated US 167.94 billion. While the pandemic certainly fuelled a recent surge, our demand for supplements is expected to continue, with the market predicted to hit USD 301.41 billion by 2030.
While the supplement industry is governed by various statutes and regulations, concerns have recently been raised over the lack of FDA (Food and Drug Administration) guidance regarding levels of impurities or other byproducts, which may increase the risk of misbranding.
When it comes to nutritional supplementation, consumers rely almost solely on product labels to make informed decisions. So, it may be a shock to learn that not all labels tell the truth.
This article will discuss everything you need to know about the role of the FDA, dietary supplement misbranding, and how to choose supplements that are 100% guaranteed safe.
What is misbranding?
Misbranding occurs when supplement labels provide false, misleading, or insufficient information about the product contents. According to the FDA, a dietary supplement is mislabeled if:
• The label or advertising material is false or misleading.
• The label doesn’t list the name and/or quantity of each ingredient supplemented, meaning that the consumer may be ingesting ingredients they would otherwise avoid.
• The label doesn’t include the words “dietary supplement” (or an acceptable equivalent).
• The product contains an herb or other botanical and fails to identify from which part of the plant it is derived.
• The product fails to meet required standards of identity, strength, quality, purity, or compositional specifications.
Adulteration is slightly different. Adulteration, by definition, occurs when products are found to be contaminated, defective, unsafe, not shown to be safe, dirty, produced under insanitary conditions, and/or manufactured under procedures and controls that do not comply with cGMP (current Good Manufacturing Practices) regulations.
Supplement misbranding has been an issue for as long as supplements and adulterated drugs have existed. Unfortunately, with the industry growing at such a rapid pace, the scale of potential harm is larger than ever.
Misbranding may not always be deliberate. But whether deliberate or not, the implications are vast.
At its most serious, incorrect labeling may pose grave health risks to the consumer. Users may be exposed to allergens or other ingredients they would normally avoid due to health conditions or interactions with other medications. They may also end up taking higher-than-expected dosages of certain ingredients, which can also have serious risks.
The Dietary Supplement Health and Education Act (DSHEA) provides a clear definition of dietary supplements as food, not drugs. This definition serves as the foundation for how they are labeled and marketed. However, despite efforts by authorities to regulate and oversee supplement labeling, the vastness of the market makes it a mammoth task.
Repeated instances of misbranding can erode consumer trust in the industry as a whole, pushing potential users away from taking “honest” supplements for health.
At the very least, consumers certainly do not want to pay more for a product they believe is of higher quality or efficacy based on misleading label information.
Types of dietary supplement misbranding
Supplement misbranding can take various forms. Some of the most common examples include:
Incorrect identification of ingredients
Selling a product under a name that doesn't correspond to its actual content. For example, selling a supplement named "St. John's Wort" that contains an entirely different herb.
Using labels that overstate the benefits of the supplement - for example, claiming that the product can "cure" or "treat" certain medical conditions, but without the scientific evidence to prove it. Supplements (dietary or otherwise) cannot claim to diagnose, treat, cure, or prevent a disease unless they have been evaluated and approved by the FDA to do so.
Wrongly claiming the source or origin of the supplement (for example, claiming that an ingredient is organic or from a certain country) is also misleading.
Incorrect dosing information
The label does not accurately reflect the concentration of the ingredients, potentially leading to overdosing or underdosing.
In other cases, the label may fail to provide necessary warnings about potential side effects, interactions with other drugs, or risks associated with the ingredients.
Omission of ingredients
Not listing all ingredients present in the nutrient supplement. This is especially dangerous for consumers with allergies or those taking medication that may adversely interact with undisclosed ingredients.
Falsifying supplement certification
Using symbols or badges indicating third-party certification or testing when the product hasn't been certified or tested by those organizations.
Using extremely small fonts or hidden panels to provide crucial information, making it difficult for the average consumer to find or read.
Role of FDA in regulating dietary supplements
The U.S. Food and Drug Administration is responsible for regulating dietary supplements to ensure consumer safety and fair marketing practices. It regulates both finished products and their ingredients, and all supplements are subject to a different set of regulations than those covering "conventional" foods and drug products.
• inspecting manufacturing establishments
• reviewing new dietary ingredient (NDI) notifications and other submissions for supplements
• investigating consumer complaints and reviewing adverse event reports from firms, consumers, and healthcare providers to identify products that may be unsafe
• monitoring the supplement marketplace
• examining products and ingredients offered for import to determine whether they meet U.S. requirements.
While the FDA doesn’t actually approve dietary supplements or their labeling, they may review and authorize the claims made by supplement manufacturers.
The FDA does not approve dietary supplements for safety and effectiveness as it is not authorized to do so. In fact, supplements can be produced and marketed without notifying the FDA at all. The only situation in which companies must submit a premarket safety notification to the FDA is if the product contains “new dietary ingredients” (i.e., ingredients that were not marketed in the U.S. before October 1994).
Besides searching for the supplements FDA approved list, consumers are wholly dependent on the company’s adherence to Current Good Manufacturing Practices (CGMPs). CGMP refers to the Current Good Manufacturing Practice for regulations enforced by the FDA. CGMP regulates the manufacturing, packaging, and holding operations of supplements to ensure their identity, purity, quality, strength, and composition. These supplement regulations are designed to prevent adulteration and misbranding of the products.
Methyl-Life® and FDA
Here at Methyl-Life®, we’re not only FDA-registered and audited but wholly committed to CGMP. This is evident in our rigorous testing, quality control, and adherence to standardized procedures during manufacturing, packaging, and distribution. It’s why all of our products are on the FDA approved supplements list, and why we’re one of the world’s most trusted methylfolate supplement manufacturers.
Methyl-Life®’s commitment to the quality and safety of all ingredients begins with our thorough evaluation of a supplier’s credentials and certifications. We only work with manufacturers who are NSF-certified (National Sanitation Foundation). This is the highest level of assurance that a product has not only gone through the specified standard operating procedures strictly guided by the FDA, but that it has exceeded those standards and can be verified by a trusted independent organization. NSF certification ensures every aspect of a product's development is thoroughly evaluated; a requirement that goes well beyond that of the FDA’s.
Also unlike FDA requirements, NSF certification means products are continuously re-tested and manufacturing facilities are subject to regular inspections.
All of Methyl-Life®'s suppliers must be able to show that they are compliant with manufacturing regulatory standards. They must also have proven track records in delivering quality ingredients. All ingredients used in our formulas have extensive and detailed paperwork that is required and delivered for each batch ordered (the product manufacturer files these documents for traceability). No ingredient is received or used in any finished product for Methyl-Life® without this paperwork. Examples of some traceability documents include: ingredient source statements, flow charts of the ingredient’s production/source, handling and storing specifications, certificate of analysis (e.g., USP standards regarding how each ingredient is to be tested and what is “passable” vs. “unacceptable”), allergen details, testing results for contaminants, pesticides, and heavy metals, Material Safety Data Sheet (MSDS), and any other relevant certifications (i.e. halal, kosher, non-GMO, etc.).
This dedication to quality underpins our stringent measures to maximize the safety, efficacy, and reliability of our products. Not only that, Methyl-Life® offers comprehensive information and education to help customers better understand which supplements may be most suitable for their health.
Nutrient supplementation should always be approached with caution. However, avoiding misbranded products can be as simple as checking the product label and researching the company. When choosing a supplement, check that it adheres to CGMP regulations and has the relevant certifications and approvals. It may also be helpful to check both the FDA-approved list of supplements and the FDA banned supplements list.
NSF certification demonstrates that a brand has exercised due diligence in meeting the strictest requirements for quality, compliance and safety.
Methyl-Life®’s tireless commitment to customer safety is reflected in our robust quality assurance practices. We will continue to uphold the integrity of the US supplement industry and empower consumers to make informed choices about their health and well-being.