Please oppose the Draft Guidance that FDA has proposed for “Drugs Labeled as Homeopathic.” If this Guidance is finalized, it will jeopardize consumer access to a number of excellent homeopathic remedies now used by consumers.
Take Action at FDA Here – https://www.regulations.gov/comment?D=FDA-2017-D-6580-0002 – by submitting your own comment to the FDA online, a very quick and effective method of letting FDA know you are in opposition and why.
The deadline for comments to FDA is March 20, 2018.
Take Action Here – http://org.salsalabs.com/o/850/p/dia/action4/common/public/?action_KEY=22861 – to send a letter to your Congressional Representatives asking them to submit opposition comments to the FDA too.
Read FDA Draft Guidance Here: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm589373.pdf
Read NHFA’s Comments Here: https://nationalhealthfreedom.org/nhfa/wp-content/uploads/sites/5/2017/05/NHFAs-FINAL-Comments-pdf-Draft-Guidance-Homeopathy-3.8.2018.pdf . NHFA has reviewed the Draft Guidance and submitted a 20 page formal comment opposing the Draft Guidance and recommending changes. There are two key reasons why we oppose the draft guidance:
The FDA is attempting to repeal historic guidance documents (CPG 400.400 – https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074360.htm) that has for decades acknowledged and protected the unique nature of homeopathic remedies and provided clear guidance to manufacturers regarding the marketing of these remedies.
In addition, FDA is now attempting to establish enforcement priorities for homeopathic remedies similar to all other pharmaceutical unapproved drugs, based on a general “risk-based” approach, but with even added restrictions not imposed on pharmaceutical unapproved drugs
Take Action at https://www.regulations.gov/comment?D=FDA-2017-D-6580 and ask FDA to honor and protect access to all homeopathic remedies.