I’m sure most of us have taken a multi-vitamin/mineral or other supplement and noticed a change in our urine color. Or maybe even had one that didn’t quite agree with our stomach. From an upset stomach with a new protein shake to feeling bloated from a new probiotic, minor adverse health effects are not uncommon with nutritional supplements. 

But did you know that Thorne tracks every single one to ensure complete product safety and to eliminate as many unpleasant reactions as we possibly can? Not only is this a requirement of the U.S. Food and Drug Administration (FDA), but just like any other quality or safety program you’d expect from Thorne, we have an extensive process to monitor adverse events for every product. 

Let’s start with the basics. What is an adverse event? 

The FDA defines an adverse event as “any health-related event associated with the use of a nutritional supplement that is adverse.” And yes, this includes urine discoloration from B vitamins and digestion changes from probiotics. 

What an adverse event is NOT is a complaint about a product’s packaging, taste, aroma, or other complaints of physical characteristic of the product. (Oh, we extensively track those too, but that’s a topic for another day.)

Why does Thorne care so much about adverse events?

First of all, we care about you. We want to ensure you have the best experience possible with each Thorne product, every time.

Second, by ensuring we thoroughly document consumer experiences with our products, we create an additional layer of information collection to assess any possibility of a trend in product concerns with a formula or otherwise. 

What is different about the way Thorne tracks adverse events?

To maintain objective analysis of adverse events, Thorne utilizes an independent third-party company to follow up with customers. This ensures information is collected consistently and thoroughly and without any possibility of bias or dismissal. 

SafetyCall International is an adverse event monitoring company that services the nutritional supplement industry, as well as the pharmaceutical and other industries. SafetyCall is widely known as the industry standard. Thorne utilizes SafetyCall as our service for collection and customer follow-up for adverse event monitoring.

What sort of information does Thorne track?

Thorne has an Adverse Event Review Committee that is responsible for the review and analysis of every adverse event associated with Thorne products. The Committee is composed of members of our Medical Affairs Department, Quality Assurance Department, executive leadership, General Counsel’s office, and outside advisors. The Committee meets monthly to review every adverse event individually, as well as to assess any possibility of trends in the products, lots, or types of complaints associated with a product. A score is established of the number of events per bottles sold and servings sold, and we track and review these scores over time. The Committee meets at monthly, quarterly, and annual intervals, as well as assessing for trends year-over-year. Any out-of-the-ordinary concern will initiate an investigation of the product for laboratory analysis, formula review, or any other measure we believe is necessary to rule out issues with product quality. 

What process can you expect if you experience an adverse event?

If you have a health concern about a Thorne product and reach out to Customer Service, then even if you’re reaching out for a refund or to cancel an order, your adverse event record will be initiated and forwarded to SafetyCall for collection of additional information and tracking. You will be asked to provide to the Customer Service representative the product name, lot number, and a brief summary of your experience with the product. 

After your information is collected by Customer Service and forwarded to SafetyCall, SafetyCall will call or email you to follow up on your concern. You can expect SafetyCall to ask more detailed questions about your experience, your medical history, and use of other products or medications to assess any possibility of interaction. The health history and information you share is kept secure and confidential and is only used for the purpose of adverse event monitoring.

Although we understand that it might seem excessive, or downright inconvenient, to discuss your product experience, even if it’s a bit of probiotic bloating, it’s important to us that you do discuss it with us. 

To be prepared for reporting your adverse event, here’s a checklist of the information that will be requested:

  • Product name or SKU – a SKU is a unique code for each product and can be found next to the bar code on the product label.
  • Lot number – this is often found printed on the bottom of the bottle or carton or along the bottom edge of a powdered product.
  • Type of event – such as bloating, upset stomach, diarrhea, rash, headache, etc.
  • History of use – for example, when did you start taking the product, when did the adverse effect start, did the adverse event go away when you stopped taking the product, did you try it a second time, etc.
  • Other health history – other current or history of health events that might be associated with your event type.
  • Product/medication use – any other supplements, medications, or other factors that might be associated with your adverse event.

What is Thorne’s track record for adverse events?

I’m so glad you asked! Our annual review of 2022’s adverse events history by the Adverse Events Review Committee found one adverse event for every 650,000 servings. This means the likelihood that you will have an adverse event from a Thorne supplement is only 0.00015 percent per serving. That’s a LOT of capsules and not a lot of adverse events.

Thorne is very proud of our adverse monitoring process, procedures, and statistics. It’s just another part of what we put into our standards to keep our customers happy and healthy. We thank you so much for your patience and cooperation in continuing to make that happen year after year, and decade after decade.