American Health & Medical Research Association
Safety & quality

What belongs on a supplement list, and where reports go

What a federal agency's own record form says a supplement list should contain, and why federal sources still disagree about where a consumer reports a bad reaction.

Sources12, listed below Reading time14 minutes
On this page
  1. The gap a written list is meant to close
  2. What a federal agency's own record asks for
  3. Name, dose, route, frequency, purpose
  4. Bring the bottle, not the memory
  5. Where a supplement problem actually gets reported
  6. The things only the package knows
  7. How little of this ever reaches a federal database
  8. The useful version of all this

The most common reason Americans do not tell a doctor about the supplements they take is not embarrassment. It is that nobody asked.

That finding comes from a nationally representative household telephone survey across the 48 contiguous states, published in Annals of Internal Medicine in 2001 and reporting on use during 1997. Among 831 adults who had both seen a medical doctor and used a complementary therapy in the previous year, between 63 and 72 percent had not mentioned at least one of those therapies to the doctor. When the 507 respondents who gave reasons explained why, the top two were that it did not seem important for the doctor to know, at 61 percent, and that the doctor never asked, at 60 percent. Only 14 percent expected disapproval.

That reframes the problem. The standard advice, tell your doctor what you take, assumes the obstacle is reluctance. The data say the obstacle is that the question never comes up and the patient does not think the answer matters. Both of those are solved by the same object, and it is not a conversation. It is a piece of paper, or its equivalent on a phone, that exists before the appointment starts and gets handed over without anyone having to remember anything.

This article is about that document, what belongs in it, and what happens to it afterward if something goes wrong. Article 779 covers the conversation itself. What follows is the paperwork and the plumbing.

The gap a written list is meant to close

The 1997 survey is old, and its age should be stated rather than hidden. It remains the most thoroughly characterized data on why disclosure fails, and later work has not overturned the pattern.

A 2009 retrospective review published in BMC Complementary and Alternative Medicine, drawn from a university hospital’s anesthesia preoperative clinic, cited published disclosure rates ranging from 30 to 46.7 percent. Its authors listed the reasons researchers had identified: patients are never specifically asked, embarrassment, and a belief that herbal products are not medicine at all. They offered a plausible account of where that belief comes from. These products cost little, need no prescription, and are marketed as natural, and patients may read natural as safe.

The same paper makes the sharpest counterpoint in two lines. Plenty of potentially toxic prescription drugs come from plants: digitalis from foxglove, quinine from cinchona bark, vincristine from periwinkle, paclitaxel from the Pacific yew. Botanical origin has never been a safety category.

That review also documented something about scale. Patients in that clinic who were taking natural products were simultaneously taking an average of six prescription medicines and three non-prescription ones. That is the interaction surface a list is meant to make visible, and nine or ten entries is more than most people reconstruct accurately from memory in an exam room. Article 353 covers how interactions happen. Article 357 covers the specific problem of disclosure before surgery, which has its own timing trap.

One structural finding from that paper is worth carrying forward. Hospitals do have established methods for taking a medication history, but those methods vary between institutions and even between individual clinicians inside one institution. Which means the completeness of your record is partly up to you, because the question you get asked is not standardized.

The population this matters most to is easy to identify. The National Health and Nutrition Examination Survey recorded its highest rate of supplement use anywhere among women past the age of 60: 80.2 percent had taken something within the previous 30 days. Four in five. That is also the age band most likely to be taking several prescriptions, to see more than one specialist, and to arrive at a hospital without a relative who knows the shelf.

What a federal agency’s own record asks for

There is a patient-facing tool for this, published by a federal agency, and it is free. The NIH Office of Dietary Supplements publishes a printable form called My Dietary Supplement and Medicine Record. Its instruction at the top is to enter everything: dietary supplements, prescription drugs and over-the-counter medicines together, in one place. Its other printed instruction is to print the record and share it with doctors, pharmacists or other health professionals at every visit.

The column headings are the interesting part, because they answer the question of what a useful record contains in an agency’s own words rather than in a blogger’s.

The first column asks what you are using, and then specifies the product name and active ingredients. That split is doing real work. Two products with completely different names on the front can carry the same active ingredient, and a clinician reading only a brand name has no way to know. The name sells the product. The ingredient list is the thing that interacts with a drug.

The second column asks what the product looks like: color, shape, size, markings. This is the field people skip and emergency clinicians want most, because a pill that has been decanted into a weekly organizer has lost everything that identified it.

Then: how much, how to use and when, start and stop dates, why you are using it, and who told you to use it along with how to contact them.

Start and stop dates deserve a sentence of their own. Timing is the only thing that links a new symptom to a new product. A record that says what you take tells a clinician very little. A record that says what you started three weeks ago tells them where to look first.

The form also prints a set of questions to ask about any product, covering special directions for use, whether to avoid other supplements, medicines or treatments, whether to avoid any foods, drinks or activities, what side effects to watch for, what to do if one appears, and what to do about a missed dose.

Name, dose, route, frequency, purpose

Hospitals work from a parallel skeleton, and seeing it explains why the fields above are the fields.

The Joint Commission, the organization that accredits most American hospitals, sets a National Patient Safety Goal numbered NPSG.03.06.01. Its goal statement is to maintain and communicate accurate medication information for the individual served. One element of performance tells organizations to define the types of medication information they collect, and gives this list as its example: “name, dose, route, frequency, purpose.”

The next element is the one that explains why your list matters. Organizations that prescribe medications are told to compare the medication information the person brought with them against what the organization has ordered, in order to identify and resolve discrepancies. Your list is literally one side of that comparison. If it is thin, the comparison is thin.

A further element tells organizations to explain the importance of keeping medication information current, including when new products are added, and it names over-the-counter products specifically.

Now the honest limit, because this is routinely overstated. In the chapter reviewed for this article, the Behavioral Health Care edition dated July 2023, vitamins, herbal products and dietary supplements are not named anywhere. Over-the-counter products appear only as an example. The elements of performance point readers to a glossary definition of medications, and the published chapter does not contain that glossary. So the claim that accreditation standards formally require supplements to be included in medication reconciliation cannot be settled from the document itself. What can be said is narrower and still useful: the standard exists, it runs on a comparison against what the patient brings, and nothing in it stops a supplement from being on that list.

Bring the bottle, not the memory

The Agency for Healthcare Research and Quality, the federal agency that studies how health care is delivered, publishes a one-page Medicine Review Handout as part of its Health Literacy Universal Precautions Toolkit, third edition. The page was created in February 2024 and last reviewed in March 2024.

It asks patients to bring prescription medicines, over-the-counter medicines, herbal medicines, and vitamins and supplements. Herbs and supplements are named as separate categories, which matters, because a patient who hears the word medicines often does not think either one counts.

It also asks for all creams, liquids, and anything breathed in or given by needle. And for pills, it asks for something more specific: bring them in the bottles they came in, along with any pill boxes used to organize them. Both, not either.

Note the precision there. The instruction to bring original containers is written for pills. The handout does not say the same about creams or liquids. That distinction is the agency’s, not an oversight to paper over.

Why containers rather than a typed list? Because of what is printed on them and nowhere else.

Where a supplement problem gets reported

Here is where a reader following standard advice hits a wall, and the wall is built out of two federal sources that point in different directions.

FDA’s own page on reporting an adverse event handles dietary supplements in one sentence. Its instruction to anyone who thinks a supplement may have caused a serious reaction or illness in themselves or someone they know is to stop using the product immediately and file a safety report through the Safety Reporting Portal, at safetyreporting.hhs.gov. The page gives the click path: log in or report as a guest, choose to start a new report, then select the option for a private citizen, business or veterinary provider submitting a voluntary report. Technical help comes from SRPSupport@fda.hhs.gov. The page offers no phone number for supplement reports at all, and it does not mention MedWatch.

MedWatch is the program most people have heard of, and the consumer version of its reporting form carries the same redirect. FDA Form 3500B, whose footer prints the revision code 01/25, lists among the problems it is not for food, cosmetic or dietary supplement products, and sends them to the Safety Reporting Portal. The form’s own routing instruction points away from the form.

Then the same document contradicts itself. Section C asks what the report is about and offers four choices, one of them Dietary Supplement. The form that tells a reader not to report a supplement on it also prints a box saying that is exactly what they are reporting. The contradiction sits in that one question: Section C’s separate question about product type offers only over-the-counter, compounded, generic and biosimilar, with no supplement option at all.

Somebody who starts filling in the consumer form therefore reaches a category that appears to fit, several lines below the instruction telling them to go elsewhere. The form’s paperwork approval is stale too. It carries OMB control number 0910-0291 with an expiration date of 06/30/2025, and the copy served in October 2026 still prints that expired date.

Meanwhile the NIH Office of Dietary Supplements consumer fact sheet, last updated January 4, 2023, tells readers that if they think they have had a bad reaction they should let their health care provider know, and that the provider may report it to FDA. It then says a report can be submitted directly to FDA by calling 800-FDA-1088 or by completing an online form. That phone number is the MedWatch line. The online form it links to does land on the Safety Reporting Portal.

So the discrepancy is narrower than it first looks, and more awkward. The web destination is the same across all three sources. The telephone number is not: one federal agency publishes a MedWatch phone line for supplement reactions, while FDA’s own reporting page and its consumer form route supplements away from MedWatch entirely. A reader who calls the number may well be redirected. A reader who reads the form and assumes there is no way to report by phone has also been misled.

Two practical details about the portal are easy to miss and remove most of the friction. A report can be filed as a guest, with no account to create. And the reporter does not have to be the person affected, which matters for a parent, an adult child or a caregiver who is the one holding the bottle.

The fact sheet adds one step neither FDA page does, and it is worth knowing: report the reaction to the manufacturer too, using the contact details on the product label. A separate point of order is that complaints about misleading supplement advertising go to the Federal Trade Commission rather than FDA. Article 352 covers what happens to reports once a federal agency has them.

The things only the package knows

The product information a consumer report asks for explains the bring-the-bottle instruction better than any general argument could.

FDA’s consumer form asks for the name of the product exactly as it appears on the box, bottle or package. It asks for the name of the company that makes the product. It asks for the lot number and the expiration date.

Two of those four exist only on the container. A lot number is how a manufacturer identifies one production run, and it is the single field that lets an agency connect your report to someone else’s report about the same batch. It is printed, often stamped, on the bottle. It is not on a receipt, it is not in a shopping app, and it will not be in your memory. Throw the bottle out and that information is gone permanently.

Which produces a short, practical rule that no source states and the documents jointly imply: when a product causes a problem, the bottle becomes evidence. Keep it.

Here is a record checklist built around what fails without each piece, rather than around the order any one form happens to use:

  • Active ingredients, because the name on the front does not tell a pharmacist what is in it.
  • Amount per serving and servings per day, because dose is the question every clinician asks second.
  • The date you started, because without it no symptom can be matched to any product.
  • A photograph of the label and the lot number, because this is what a report and an emergency department need and what the trash can takes away.
  • The reason you are taking it, because that is what makes the item possible to stop, substitute or keep.
  • Anything stopped and when, because the list of what you no longer take explains symptoms too.

How little of this ever reaches a federal database

The under-reporting figure everyone quotes is real, and it is a quarter of a century old. Anyone who prints it without a date is misusing it.

The HHS Office of Inspector General published a report titled Adverse Event Reporting System for Dietary Supplements: An Inadequate Safety Valve, numbered OEI-01-00-00180 and issued on April 17, 2001. In congressional testimony presenting that work, Michael F. Mangano, then Principal Deputy Inspector General, told a Senate subcommittee that a study commissioned by FDA in March 2000 had estimated that the agency “receives less than 1 percent of all adverse events associated with dietary supplements.”

Two further numbers from that testimony fill in the picture. FDA received 2,547 supplement-related adverse event reports in total between 1994 and 1999. And for 1999 alone, the review found FDA received 460 reports while Poison Control Centers nationwide received an estimated 13,000.

Date that properly and the figure still carries weight, but a different kind. It predates the law that has required industry to report serious adverse events since the mid-2000s, so it does not describe the current system. No more recent federal estimate of the under-reporting rate could be located for this article, which is itself a finding worth stating. The honest sentence is that the best-documented under-reporting estimate in this field describes the late 1990s.

What exists instead is surveillance, which counts harm directly rather than waiting for reports. Researchers from the Centers for Disease Control and Prevention and FDA, publishing in the New England Journal of Medicine in 2015, used nationally representative data from 63 emergency departments between 2004 and 2013 and estimated 23,005 emergency department visits a year attributable to adverse events related to dietary supplements, with about 2,154 of those visits leading to hospitalization annually. That window closed in 2013 and no newer national estimate has replaced it.

Those two approaches are not directly comparable, and presenting them as a ratio would be arithmetic dressed up as evidence. The point they make jointly is simpler. Counting harm by waiting for voluntary reports finds a small fraction of what counting harm by watching emergency rooms finds.

The useful version of all this

Keep the record because of the one moment it pays for itself, which is the moment you cannot answer questions.

If a new symptom appears within days or weeks of starting something, if a symptom eases after a product stops and returns when it starts again, or if anything lands you in urgent care, the clinician in front of you will want product names, ingredients, amounts and dates, and will want them in minutes. That is not a situation anyone reconstructs well. It is a situation a one-page list and a shelf of original bottles solves outright.

The field most often missing from a home-made list is also the most load-bearing: active ingredients. Add it, add a start date beside each item, photograph the label, and the record will do its job even when you cannot explain it yourself.

Sources

  1. U.S. Food and Drug Administration. “Report an Adverse Event (reporting pathway for dietary supplements via the Safety Reporting Portal).” fda.gov
  2. U.S. Food and Drug Administration. “Form FDA 3500B, MedWatch Consumer Voluntary Reporting (footer revision code 01/25; OMB No. 0910-0291, expiration date 06/30/2025; copy read October 21, 2026).” fda.gov
  3. National Institutes of Health, Office of Dietary Supplements. “My Dietary Supplement and Medicine Record (printable record form).” ods.od.nih.gov
  4. National Institutes of Health, Office of Dietary Supplements. “Dietary Supplements: What You Need to Know (updated January 4, 2023).” ods.od.nih.gov
  5. Agency for Healthcare Research and Quality. “Tool 8A: Medicine Review Handout, Health Literacy Universal Precautions Toolkit, 3rd Edition (created February 2024, last reviewed March 2024).” ahrq.gov
  6. U.S. Department of Health and Human Services, Office of Inspector General. “Adverse Event Reporting System for Dietary Supplements: An Inadequate Safety Valve, Report OEI-01-00-00180, issued April 17, 2001.” oig.hhs.gov
  7. U.S. Senate (testimony of Michael F. Mangano, Principal Deputy Inspector General, HHS). “Statement on the adverse event reporting system for dietary supplements, Senate subcommittee hearing on consumer safety and weight-loss supplements.” hsgac.senate.gov
  8. The Joint Commission. “National Patient Safety Goals, Behavioral Health Care and Human Services chapter, July 2023 (NPSG.03.06.01, medication information).” jointcommission.org
  9. Centers for Disease Control and Prevention, National Center for Health Statistics. “Mishra S, Stierman B, Gahche JJ, Potischman N. Dietary Supplement Use Among Adults: United States, 2017-2018. NCHS Data Brief No. 399, February 2021.” cdc.gov
  10. Annals of Internal Medicine (verified via PubMed). “Eisenberg DM, Kessler RC, Van Rompay MI, et al. "Perceptions about complementary therapies relative to conventional therapies among adults who use both: results from a national survey." Ann Intern Med, 2001;135(5):344-351. PubMed. DOI: 10.7326/0003-4819-135-5-200109040-00011.” doi.org
  11. BMC Complementary and Alternative Medicine (full text verified via PubMed). “King AR, Russett FS, Generali JA, Grauer DW. "Evaluation and implications of natural product use in preoperative patients: a retrospective review." BMC Complement Altern Med, 2009;9:38. PubMed. DOI: 10.1186/1472-6882-9-38.” doi.org
  12. The New England Journal of Medicine (verified via PubMed). “Geller AI, Shehab N, Weidle NJ, et al. "Emergency Department Visits for Adverse Events Related to Dietary Supplements." N Engl J Med, 2015;373(16):1531-1540. PubMed. DOI: 10.1056/NEJMsa1504267.” doi.org