As a consumer of dietary supplements you know that they are very important to your health. And it isn’t just you. Millions of Americans depend on multivitamins, minerals, herbal extracts, and specific formulas to boost their energy, fill in nutritional gaps, and support overall well-being. But how safe are they?
Critics often paint supplements as unregulated products, just wild-cards on the market. Who knows what’s really inside those bottles? But proponents counter that they’re far safer than many over-the-counter (OTC) drugs we take without a second thought. As the late Andrew Saul, who was a prominent advocate for orthomolecular medicine, famously asked, “Where are the bodies?”—which highlights the basic difference between dietary supplements and drugs. In this blog we’ll dive into the regulatory framework governing supplements (yes, there are quite a lot of rules), the inspection process (yes, inspections are a thing), and a look at what the data says about adverse events and deaths from dietary supplements. Let’s separate fact from fiction here.
What About cGMP Regulations? Are They Enough?
Dietary supplements in the U.S. are regulated by the Food and Drug Administration (FDA). There is a special section of the law in 21 CFR Part 111, titled, “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.” These are the cGMP rules people refer to. Supplements are considered foods and regulated as such, rather than being treated like drugs. An industry acronym for cGMP is actually “Great Mounds of Paper,” as the documentation is enough to require hiring a person just to manage all of the documents.
How Supplements Claims are Different from Drugs
So, supplements have their own set of regulations. This doesn’t mean that safety is compromised. This just means that you aren’t required to have long clinical trials proving a benefit of the supplement to put it on the market. And you are not allowed to make any claims—(you’ve seen the disclaimer: “This product is not intended to diagnose, treat, cure, or prevent any disease”.) You can only make structure-function claims. Like “supports joint health” or “supports blood sugar levels already in the normal range.” or “helps the body maintain optimal levels of vitamin D”. Claims like that are OK.
But you can’t say, “Helps reverse heart disease” or “Lowers cholesterol” or “Helps manage high blood sugar levels.” Or even, “Good for preventing dementia.” Those claims are all disease treatment claims and not acceptable, and could get your product pulled from the market as an “unbranded drug.”
cGMP Regulation Overview
So, that is how dietary supplements are different from drugs. But in the actual production of the dietary supplements, the regulations are similar. The cGMP regulations aim to prevent contamination, mislabeling, and inconsistencies that could harm the people taking them. Here are some of the key requirements:
- Personnel and Facilities: Staff must be qualified and trained, and facilities kept clean and sanitary to avoid contamination. Equipment must be calibrated and maintained properly. This means lots of training for staff, wearing hair nets, beard nets, lab coats over street clothes, and shoe covers. This means floors that can be easily cleaned. This also means testing equipment, calibrating equipment, cleaning equipment, calibrating equipment again, and documenting everything.
- Quality Control Systems: Establish processes to verify the identity, purity, strength, and composition of ingredients and finished products. So, every batch of raw materials that is received goes into quarantine and a sample is sent out for testing to verify identity and purity (no contaminants, safe levels of heavy metals, no bacteria, yeast or mold). Then after a batch is made several samples are sent out to a third-party lab for testing again. Each ingredient is assayed (or at least several to assure the formula was made correctly) to make sure it has at least 100% of the label claim, and not more than 120% of the label claim. The final product is also tested for microbial contamination and heavy metal levels. (There is no such thing as zero levels of heavy metals, just safe(r) levels.)
- Master Manufacturing Records (MMRs): A very detailed recipe for each product is created, including specifications for strength, concentration, weight, or measure. Nothing is left to chance or guessing or to “about a tablespoon of this or that.” Quantitative measuring by weight is the normal requirement.
- Batch Production Records: Documentation. Lots of documents for every step in production. This is used to trace any issues back to the source. Two people help weigh every ingredient, and sign off on the sheet as they go down the list of ingredients. There are lots of signatures and a final sign off by the quality control manager.
- Labeling: Labels are carefully designed to be accurate, truthful, and are checked by the owner for compliance with DSHEA structure-function claims. (This is where some companies take liberties.) The FDA disclaimer mentioned above is also included. Tamper-evident seals are applied to products and products are stored in rodent-free zones. The FDA has authority to ensure that label claims follow the regulations.
- Complaint Handling: Systems are installed to investigate consumer complaints and potential adverse events.
While cGMP is less stringent than drug GMP (21 CFR Part 211), the regulations are designed to ensure supplements are produced consistently and safely. If you follow the rules, there are no issues with safety. If a company doesn’t follow the rules, making more rules for the rule-keepers won’t fix that. Enforcement of existing regulations is all that is required.
FDA Inspections: Intense, Thorough, Brutal if Not Prepared
Companies are not required to submit their products to the FDA before putting them on the market. However, post-market surveillance inspections help enforce cGMP compliance. Reputable contract manufacturing companies who have been through this process a few times have no issues, but newer companies may learn a thing or two when they get inspected. Inspections can be routine, because of customer complaints, or surveillance-based. In fiscal year 2023, the FDA performed over 500 inspections related to dietary supplements.
What gets inspected? Pretty much everything:
- Operations and Quality Management Systems (QMS): Inspectors review the entire manufacturing process, from raw material intake to finished product distribution. They check for proper hygiene, equipment maintenance, and quality controls to prevent cross-contamination or adulteration. Physical inspections are coupled with documentation inspections.
- Testing and Specifications: Verification that ingredients and products meet identity, purity, and strength specs. Common issues include missing specs for components or finished products.
- Labeling and Claims: Labels are scrutinized for accuracy and compliance—no disease claims allowed, and all ingredients must be listed.
- Complaint and Adverse Event Handling: Systems for tracking and investigating reports from consumers.
Paperwork is crucial—it’s the proof of compliance. Inspectors dive into:
- Master manufacturing records and batch records to ensure reproducibility and traceability.
- Standard operating procedures (SOPs) for all processes.
- Testing results from labs (e.g., for contaminants).
- Supplier qualification documents and complaint logs.
If violations are found, the FDA issues a Form 483 notice, and companies must respond with corrective actions. Severe issues can lead to warning letters, seizures, or injunctions. This paperwork trail helps the FDA hold manufacturers accountable and protect consumers.
Comparing Safety: Supplements vs. OTC Drugs—Where Are the Bodies?
Now, let’s address the elephant in the room: actual harm. Andrew Saul’s provocative line, “Where are the bodies?” underscores a key argument—while pharmaceuticals rack up massive death tolls, supplements rarely do. Saul points out that estimates place yearly deaths from pharmaceuticals in the hundreds of thousands, while vitamins and supplements cause virtually none. For instance, reports from the Orthomolecular Medicine News Service indicate zero deaths from vitamins in 2015, and none from supplements or minerals overall.
Data backs this up. From 2004–2013, dietary supplements were linked to about 23,000 emergency department (ED) visits and 2,000 hospitalizations annually in the U.S., per nationally representative surveillance. Many involved unsupervised child ingestions (21%) or swallowing issues in older adults (nearly 40% for micronutrients). About 72% of the adverse events for palpitations, chest pains, and tachycardia were due to weight loss and energy supplements, which are a bit sketchy as supplements go anyways. Overall, these numbers are dwarfed by pharmaceuticals—less than of 2% of drug-related ED visits (1.5 million) and less than 0.5% of hospitalizations (500,000). And when death statistics are examined carefully, there is zero credible evidence that anyone was harmed by normal dietary supplements, as shown in the presentation by Andrew Saul.
Acetaminophen and Aspirin: Far More Deaths than Supplements
Compare that to OTC drugs like acetaminophen (Tylenol) and aspirin:
- Acetaminophen causes over 450 deaths and 26,000 hospitalizations every year from liver toxicity, often from unintentional overdoses. It’s the leading cause of acute liver failure in the U.S. (Link)
- Aspirin and other NSAIDs (like ibuprofen) are linked to thousands of gastrointestinal bleeds annually; one study showed higher GI adverse events with aspirin than ibuprofen or acetaminophen. Overall, NSAIDs cause about 3,500 deaths per year in the elderly alone from ulcers and bleeding. This number is highly debated, and it could be much higher when all of the cardiovascular and kidney side effects of NSAIDS are taken into account (Link to GreenMedInfo).
Drugs are Far More Dangerous Than Supplements
Broader pharma stats: Adverse drug reactions to properly prescribed and administered medications kill over 100,000 Americans yearly, per some conservative estimates. And a report by Makary and Daniel estimates that medical errors are the third leading cause of death in the USA. The FDA’s Adverse Event Reporting System (FAERS) logs far more reports for drugs than the Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) does for supplements. Underreporting is an issue for both, but the scale differs dramatically.,
Supplements aren’t risk-free—adulterated products or interactions can cause harm, so you have to be alert to potentially adulterated products. (See our blog about that.) However, the data shows they’re exponentially safer than “safe” OTC drugs. As Andrew Saul noted, no deaths from herbs, homeopathy, or traditional medicines either. So, where are the bodies? They are found under the stats for drugs, not dietary supplements.
Are the Critics Really Worried About Safety?
Critics of dietary supplements do not appear to be really interested in safety, but in control and tighter access to beneficial dietary supplements. Requiring more regulations for those companies already following the regulations will not help improve compliance for companies that are putting out illegal formulas. The FDA has authority to go after falsified formulas, which makes sense to me. Just punish the criminals, and leave the innocent people alone who want to be healthy.
Conclusion: Facts Show Dietary Supplements are Safe
Just taking a look at the cGMP guidelines should give you some assurance that reputable companies already have enough regulations to consistently produce high quality supplements that meet label claims and are free of microbes and meet heavy metal standards. FDA inspections enforce the cGMP regulations. And there are indeed “Great Mounds of Paper” to document everything. But just beyond the paper trail, the facts show that OTC drugs like Tylenol and aspirin cause thousands of deaths annually while supplements cause none. The evidence speaks for itself. Dietary supplements from reputable companies are indeed safe.
