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BlogQualityFDA and Supplements: Regulations, Responsibilities, and Safety
Dietary supplements are becoming an increasingly popular or adjunct to pharmaceutical medications. However, when purchasing supplements in-store or online or recommending supplements to your patients, it’s important to ensure you’re sourcing supplements from reliable distributors with quality measures in place, such as those following United States Food and Drug Administration (FDA) guidelines. Keep reading to learn more about the FDA’s role in healthcare and supplement quality assurance.
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Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, the FDA has defined dietary supplements as ingestible products containing a dietary ingredient that is intended to supplement your diet. Dietary ingredients can be vitamins, minerals, herbs and botanicals, amino acids, probiotics, or any combination, concentrate, or extract of those categories.
In addition to the active ingredient(s), dietary supplements can also contain other ingredients such as fillers, binders, excipients, preservatives, sweeteners, and flavorings. , and the label must display the term “dietary supplement” or a similar equivalent. (8)
According to DSHEA, the FDA isn’t authorized to approve dietary supplement products before they’re marketed publicly unless the product contains a New Dietary Ingredient (NDI). An NDI is a dietary ingredient that wasn’t sold as a supplement in the United States before DSHEA was enacted in 1994. NDIs must be naturally occurring in a food source and can’t be chemically altered.
The only time the FDA can approve dietary supplements prior to the product being marketed is when the supplement product contains an NDI. In this case, the company must notify the FDA and provide sufficient evidence that the NDI is safe to consume. (8)
The FDA enforces the laws and regulations for supplement products, helping consumers and healthcare providers remain safe and informed. As part of this enforcement, they conduct inspections and monitor the marketplace, as well as examine dietary supplements and ingredients being imported into the country.
To ensure full product transparency, the FDA requires supplement product labels to include the following:
A domestic phone number or address for reporting a serious adverse event
A Supplement Facts panel showing serving size, number of servings, all ingredients (unless they’re part of a proprietary blend), amount of the ingredient(s) per serving, and a list of any other ingredients (non-dietary ingredients)
The name and place of business of the manufacturer, packer, or distributor
The term “dietary supplement” or its equivalent (8)
Manufacturer’s responsibilities
Before beginning operations, any facility that manufactures, processes, packs, or holds dietary supplements or ingredients must register with the FDA.
Prior to marketing their supplement product, if the product contains an NDI, manufacturers must notify the FDA 75 days before introducing the product to interstate commerce and provide information on why they’ve concluded that the ingredient is safe for consumption.
If the product doesn’t contain an NDI, manufacturers are responsible for ensuring the product follows current Good Manufacturing Practices (GMPs), which make it easy for a product to be identified and ensure its quality, purity, strength, and composition.
If a manufacturer makes a claim of general well-being or about how their product will affect the human body or benefit a classical nutrient deficiency disease, they must have evidence to support these claims.
If an adverse event is reported to a manufacturer, the company is required to record and investigate it, and then forward any serious adverse event claims to the FDA for further evaluation. Following this adverse event procedure is vital to catching any safety concerns early and rectifying them. (8)
Consumer safety and education
It’s important to be educated about the products you’re recommending to your patients and know how to recognize and report an adverse event should you or your patients experience one. As a healthcare professional, you’re also responsible for understanding the products you recommend to patients.
In 2022, the FDA launched a dietary supplement education initiative called Supplement Your Knowledge, where they provide fact sheets, videos, and a curriculum designed to help consumers, educators, and practitioners expand their knowledge of the industry and understand the benefits and risks of supplement use. (4)(9)
Knowing where the supplements you recommend to your patients are coming from is another vital method of staying informed and ensuring patient safety. At Fullscript, we maintain high quality-control measures. We carry professional-grade dietary supplements and screen for cGMP and third-party certifications among the brands we carry. Our distribution centers are in compliance with cGMP standards, and we ensure proper and safe storage, transport, and delivery of dietary supplements.
Ordering dietary supplements recommended by your healthcare professional through Fullscript rather than third-party reseller sites like Amazon helps ensure that you can purchase and recommend supplements with confidence, knowing that you and your patients are getting a high-quality product every time.
Oversight challenges and responses
Despite all the measures in place, the FDA still faces challenges. These challenges may involve combatting misinformation in an online age where trust in regulatory institutions is questioned, such as during the COVID-19 pandemic. (11) Balancing the need for rigorous testing on new products with the imminent need for those products in the market is also a challenge. (2)
Recently, the FDA faced a challenge in the form of controversy regarding N-acetyl-L-cysteine (NAC) in dietary supplements. After receiving two citizen petitions requesting that NAC not be excluded from the definition of a dietary supplement, the FDA launched a review and ultimately denied this petition. It was determined that NAC is excluded from the definition of a dietary supplement because it was approved as a new drug before it was marketed as a supplement.
This created complications in assessing and regulating other products that contained NAC but were labeled as dietary supplements. The FDA acknowledged that, after over 30 years of circulation of NAC-containing products labeled as dietary supplements in the United States, many consumers wanted to continue having access to these products.
In a final update on the matter, the FDA announced that the safety investigation of NAC had concluded and the organization intends to move forward with exercising discretion in the regulation of the sale and distribution of products labeled as dietary supplements containing NAC. (5) This is a positive resolution as it means that dietary supplements containing NAC will remain available so long as no safety concerns are linked to them.
The bottom line
In conclusion, The FDA plays a vital role in regulating the dietary supplement market to ensure the safety of consumers. However, it’s still up to you as a practitioner to stay informed on the latest supplement news, the ingredients you’re recommending to your patients, and any safety concerns that may affect them. Make sure to take advantage of the resources on the FDA’s website, along with continuing to trust reliable supplement sources such as Fullscript.
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Join 100,000 healthcare providers who rely on Fullscript to dispense top-quality supplements and labs to their patients.
The information in this article is intended for healthcare practitioners for educational purposes only, and is not a substitute for informed medical, legal, or financial advice. Practitioners should rely on their own professional training and judgement, and consult appropriate legal, financial, or clinical experts when necessary.
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