What happened
Original notice title
Healing Within Products & Services, Inc. 4/17/17
From the archived source record
Chaga contains large amounts of betulinic acid . . .” “Chaga restores the resistibility to harmful organisms and increases its protecting mechanisms directed towards the fight with malignant tumors.” “Chaga possesses spasmolytic . . . antimicrobial . . . properties . . .” Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. It is prohibited to introduce or deliver for introduction into interstate commerce a misbranded drug under section 301(a) of the Act [21 U.S.C. § 331(a)]. The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Your written notification should refer to the Warning Letter Number above (CMS# 513213).
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 11bcece2ceca
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →