How many adverse reaction reports have been filed with the FDA regarding Burn Peak?
This fact-check may be outdated. Consider refreshing it to get the most current information.
Executive summary
There is no verifiable, sourced count in the provided reporting that states how many adverse reaction reports about Burn Peak have been filed with the U.S. Food and Drug Administration (FDA); the available material contains company claims of no known adverse events and general FDA guidance on how adverse events are reported, but no FDA dataset or MedWatch tally for “Burn Peak” is included in the documents supplied [1] [2] [3] [4].
1. Direct answer: the number the sources can support
The reporting supplied does not contain an actual FDA number of adverse reaction reports for Burn Peak, so the only defensible answer from these sources is that a verifiable count cannot be confirmed from the materials provided — the sources do not show an FDA MedWatch total or Safety Reporting Portal extract naming “Burn Peak” with a report count (no source lists a numerical tally for Burn Peak to cite).
2. Company and promotional claims that suggest zero reports
Burn Peak’s own product pages and promotional write-ups assert that “to date, there have been no known adverse side effects reported” and that “most BurnPeak users in 2025 report no adverse side effects when the supplement is taken as directed,” language that implies an absence of complaints but does not equate to an independently verifiable FDA report count [1] [2]. Such manufacturer-run statements are commonly part of marketing and should be treated as self-reported claims rather than confirmed regulatory statistics [2] [1].
3. Clinical/study language and how it differs from FDA reports
A press release-style clinical summary cited in the results says 87–88% of study participants reported no adverse effects in a BurnPeak observational study, which is a study result distinct from FDA adverse-event reporting and does not substitute for MedWatch or Safety Reporting Portal data [5]. Clinical or marketing study metrics describe participant experiences within a study population and are not the same as the formal adverse event reports consumers or clinicians submit to the FDA [5] [6].
4. How FDA adverse-event reporting works and why counts can be hard to find
FDA guidance explains that consumers and healthcare professionals submit voluntary reports through MedWatch or the Safety Reporting Portal and that the agency uses those reports to identify potentially dangerous products, but it also documents systemic under-reporting and difficulties in follow-up that limit completeness; a related HHS/OIG note found FDA receives less than 1% of adverse events associated with dietary supplements in some estimates and that many reports lack enough data for follow-up [3] [4] [7]. That context means even if a small number of MedWatch entries existed for a product, they might not fully represent the real-world incidence, and absent a direct FDA extract in the supplied sources, a count cannot be asserted here [7] [4].
5. Contrasts and potential confusions: similarly named products and prior FDA notices
FDA public notifications have previously flagged other weight-loss products with names like “Burn 7” for hidden ingredients and have urged reporting of adverse events, but that FDA notice pertains to a different product and does not provide evidence about “Burn Peak” specifically; conflating the two would be erroneous without direct linkage [8]. The supplied materials repeatedly exhort consumers to report problems to FDA’s MedWatch or Safety Reporting Portal but do not include a published MedWatch count for Burn Peak [8] [4] [9].
6. Implications, next steps for verification, and caveats
To obtain a definitive, independently verifiable number, one must query FDA databases directly (MedWatch or the Safety Reporting Portal) or request records from the FDA naming “Burn Peak” as the product; the current reporting neither furnishes that extract nor contradicts the manufacturer's marketing claims, so any numeric statement beyond “no verifiable count in supplied sources” would be unsupported by the documents provided [4] [3] [1]. Readers should note the potential incentive for manufacturers to minimize apparent harms in marketing materials and the regulatory reality of under-reporting and reporting thresholds that complicate drawing firm safety conclusions from absence of a published FDA count alone [1] [7].