Public Comment Period on FDA’s Homeopathy Ruling Extended for 60 Days

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FDA, FSMA, New Draft Guidance, Extends Deadline

The Food and Drug Administration (FDA) has extended the public comment period for its Draft Guidance ruling on homeopathic drugs for 60 days, bringing the deadline to May 21, 2018.

There are several ways to submit comments.  The FDA is accepting electronic comments here, or written comments to an address posted on the FDA web site here. To date, 2177 comments have been filed on the site since December.

The public can also file comments through The National Center for Homeopathy’s (NCH) web site. The NCH, in association with the American Association of Homeopathic Pharmacists (AAHP) and other organizations, is urging the public to send their congressmen and women letters to cosign that have been authored by Sen. Orrin Hatch of Utah and Representative Ryan Costello of Pennsylvania.  These letters request the FDA to incorporate key aspects of homeopathy’s current working guidelines into new Draft Guidance it proposed in December 2017. Healthcare professionals wishing to submit letters to the FDA through the NCH can find a link here.  Consumers can find a link here.

As WholeFoods Magazine reported, The FDA proposed a new risk-based enforcement approach to drugs labeled as homeopathic. The agency maintained that certain homeopathic-labeled products did not meet manufacturing practice standards and may even contain potentially harmful ingredients.

The homeopathic industry has since pushed back hard on this proposal. The AAHP  responded by stating that while they share “the FDA’s commitment to protecting public health and applauds the Agency’s plan to take quick action against illegal or unsafe homeopathic medicines,” the current guidelines were working well and the FDA could have simply amended or improved them. And in April 2015, when the FDA held its first public hearing on this, it received over 9,000 positive comments about homeopathy.

“It’s a 200 year old system of medicine that is used by millions of people worldwide and thousands of practitioners,” says Dr. Susanne Saltzman, who has been practicing homeopathic medicine for 25 years and is the Editor-in-Chief of the American Journal of Homeopathic Medicine.  “People come to me because they haven’t been helped by conventional medicine, or they can’t tolerate the side effects from pharmaceutical drugs.  Homeopathy is a safer and more effective treatment than drugs for many medical conditions.”

For retailers who may be uncertain about the status of products they are selling, WholeFoods Magazine Legal Tips author Scott Tips assures us it is still legal to sell these products.

“Absolutely one can keep selling homeopathic products,” he says. “The FDA Draft Guidance is just a proposal.”

 

For related articles see:

Legal Tips: Patricide by the FDA on Homeopathy

 

 

 

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