An AE is defined as “any health-related event associated with the use of a dietary supplement that is adverse.” Adverse means not intended and usually is not pleasant. Examples include: headache, skin rash, fatigue, injection pain, or cough after taking a supplement or drug.
The FDA requires that supplement, drug and device companies collect information on Adverse Events (AEs) to try to identify any possible safety issues. If a lot of people report an Adverse Event, FDA and the supplement maker want to know that so they can modify the product or remove it. It’s all about safety of the user.
SAE sometimes occur with drugs, over-the-counter medications, and supplements.
Yes, manufacturers are required to report SAEs to FDA within 15 days. If you were directed to this website by a supplement maker, then they have designated Supplement Safety Solutions as their responsible person. This adds a layer of independence and professionalism and reduces bias.
No, by reporting an AE to the FDA, the Supplement maker does not assume responsibility for causality.
It depends on the supplement and drug. Although there’s a general perception that supplements are safer than drugs, it’s hard to prove with data because, compared to drug companies, supplement companies don’t collect AE information as rigorously and aren’t bound by same the rigorous manufacturing processes (GMP). In addition, since supplement companies don’t formally get “FDA approval”, they aren’t required to perform the same types of safety studies (e.g., in animals and healthy volunteer studies) that drug companies do. Hence, there are more unanswered questions about safety with supplements.
If your adverse event is serious (i.e., resulted in hospitalization), then it will be reported to the FDA within 15 business days, in an anonymized form (i.e., your identity will not be known). This is a similar process to what happens with the pharmaceutical industry.
Absolutely! No personal identifying information (e.g., name or date of birth) is saved. Your phone number is only used to contact you for follow-up information, such as talking to your doctor, and is not included in any report.
FDA has staff assigned to review these reports, and to identify any important safety issues. It is FDA’s job to remove unsafe products from the market.
No. It is only after they receive multiple reports on a specific supplement or a class of supplements (e.g., fat burners) that they would potentially take action. They would take action to protect the public.
The long form provides much more information, which is helpful in assessing the safety of a particular supplement. The more information that is available, the better the assessment.
Certain populations (e.g., under 18 years of age, or a certain gender) may be more prone to a certain adverse events. May occur at a higher rate, depending on the particular supplement.
Absolutely not! We are not the DEA! Knowing everything you’re taking is important in trying to determine what caused your AE. For example, let’s say you start taking a new protein powder, and a week later develop abnormal liver function tests (i.e., hepatitis). Knowing that you are on a six-week cycle of anabolic steroids would be useful, because it’s likely that the steroids, not the new protein powder, caused the AE.
No, the FDA has a legal obligation to remove unsafe products from the marketplace. Some would argue that political forces are trying to increase the government’s ability and enforcement ability with supplement companies, and only time will tell if that is true.