FDA ISSUES FINAL RULE ON SAFETY AND EFFECTIVENESS OF TRICLOSAN IN HEALTH CARE ANTISEPTICS
On December 20, 2017, The U.S. Food and Drug Administration (FDA) published a final rule that will prohibit the inclusion of commonly used ingredient triclosan and 23 other active ingredients in antiseptics for health care environments. Following the rule’s compliance deadline of December 20, 2018, health care antiseptics containing any of the covered ingredients will not be permitted to enter interstate commerce without FDA approval of a new drug application (NDA). You will find a list of the covered ingredients below.
The scope of this rule only applies to antiseptic products (i.e. washes, scrubs, rubs, and skin preparations) used by health care professionals in health care settings. Antiseptic products intended for use by consumers are covered by two separate rules, one of which had a compliance deadline in September 2017
Why are these ingredients prohibited?
The covered ingredients were initially part of a 1994 tentative final monograph for OTC antiseptic drug products. A 2015 proposed rule called for additional data to support the safety and effectiveness of these ingredients for use in health care antiseptic products. FDA did not receive any additional data, and the available scientific evidence surrounding the ingredients was insufficient to support a determination that they are generally recognized as safe and effective (GRASE).
FDA is delaying final rulemaking for at least one year on benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol (also known as ethanol or ethyl alcohol), isopropyl alcohol, and povidone-iodine. The Agency has stated that a determination for these ingredients will be dependent upon whether ongoing studies are eventually completed, and if so, when they are completed.
Not sure how this rule applies to your health care antiseptics? Registrar Corp’s Regulatory Specialists can conduct a full review of your antiseptic product’s ingredients and labeling. We review your product’s active ingredients to ensure that they conform to the requirements specified in the applicable FDA monographs for antimicrobial drug products. We also inspect your labeling to ensure that its content and formatting conform to numerous FDA drug regulations. In addition to an extensive report of suggested revisions, you will receive a print-ready label incorporating these changes. For assistance, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.
Ingredients Deemed Not Generally Recognized as Safe and Effective under the Health Care Antiseptic Final Rule:orhexidine gluconate
Mercufenol chloride
Cloflucarban
Methylbenzethonium chloride
Fluorosalan
Phenol
Hexachlorophene
Secondary amyltricresols
Hexylresorcinol
Sodium oxychlorosene
Iodophors (Iodine-containing ingredients)
• Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
• Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
• Iodine tincture USP
• Iodine topical solution USP
• Nonylphenoxypoly (ethyleneoxy) ethanoliodine
• Poloxamer—iodine complex
• Undecoylium chloride iodine complex
Tribromsalan
Triclocarban
Triclosan
Triple dye
Combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative
Combination of mercufenol chloride and secondary amyltricresols in 50 percent alcohol
FDA ANNOUNCES NEW ENFORCEMENT APPROACH TO DRUGS LABELED AS HOMEOPATHIC
Once small and specialized, homeopathic drugs now comprise a nearly $3 billion industry. Following an increase in reported health concerns stemming from these products and a flurry of unsubstantiated health claims surrounding the industry, the U.S. Food and Drug Administration (FDA) is taking new measures to curb the widespread distribution of potentially harmful drugs labeled as homeopathic.
What are Homeopathic Drugs?
Homeopathy is a form of alternative medicine based on the principle of remedying health conditions using diluted solutions of substances that produce similar symptoms in a healthy patient.
The Food, Drug, and Cosmetic (FD&C) Act defines articles recognized in the official Homeopathic Pharmacopoeia of the United States as drugs. FDA states that homeopathic drugs “are subject to the same requirements related to approval, adulteration and misbranding as any other drug product.”
Despite this, the uniqueness of homeopathic drugs delayed them from the 1972 over-the-counter (OTC) drug review, which determined the safety and effectiveness of most OTC drugs on the U.S. market. Even now, FDA has not conducted a formal review of homeopathic drugs. Since 1988, a FDA Compliance Policy Guide (CPG) establishes provisions under which these products may be marketed without the prior FDA approval required of other drug products.
Why is FDA Cracking Down on Homeopathic Drugs?
Numerous homeopathic drugs contain potentially harmful ingredients. As recently as September 2017, a homeopathic drug facility received a Warning Letter, citing failure to establish adequate in-process controls for products containing multiple potentially toxic ingredients. One such ingredient was Nux vomica, a plant bearing constituents commonly used for rat poison.
Throughout 2017, FDA issued at least four additional letters to homeopathic drug manufacturers who failed to adequately test and control potentially toxic substances in their products. FDA charged the drugs in question as adulterated.
New Enforcement Approaches to Homeopathic Drugs
In addition to FDA, the U.S. Federal Trade Commission (FTC) has issued measures to mitigate the prevalence of unsubstantiated health claims made by homeopathic drug manufacturers. A 2016 FTC Enforcement Policy Statement requires homeopathic drug labeling to communicate that “there is no scientific evidence that the product works.” The label must also indicate that “the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”
A December 2017 FDA draft guidance explains that the Agency intends to prioritize enforcement on products that are known to cause harm to patients, including those with reported health issues and those deemed adulterated under section 501 of the FD&C Act.
FDA states it will also focus increased attention on homeopathic drugs with less overt health concerns. According to the guidance, unapproved drugs intended to treat serious or life-threatening conditions may cause a patient to delay or discontinue treatment already generally recognized as safe and effective (GRASE). Homeopathic drugs designed for vulnerable populations (e.g. infants and the elderly) may pose significant health risks even in small concentrations, in spite of treatments that have already been determined GRASE. For this reason, these drug categories may see increased regulatory enforcement.
In the previously referenced Warning Letters, FDA maintains that “nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval.” The letters and newly issued guidance suggest that FDA intends to expand efforts to hold homeopathic drug manufacturers accountable to the regulations derived from the FD&C Act.
Registrar Corp is a consulting firm that assists drug companies with U.S. FDA regulations. Our Regulatory Specialists can assist with FDA registration and drug listing, labeling requirements, and other drug regulations. For assistance or questions call +1-757-224-0177.
On December 20, 2017, The U.S. Food and Drug Administration (FDA) published a final rule that will prohibit the inclusion of commonly used ingredient triclosan and 23 other active ingredients in antiseptics for health care environments. Following the rule’s compliance deadline of December 20, 2018, health care antiseptics containing any of the covered ingredients will not be permitted to enter interstate commerce without FDA approval of a new drug application (NDA). You will find a list of the covered ingredients below.
The scope of this rule only applies to antiseptic products (i.e. washes, scrubs, rubs, and skin preparations) used by health care professionals in health care settings. Antiseptic products intended for use by consumers are covered by two separate rules, one of which had a compliance deadline in September 2017
Why are these ingredients prohibited?
The covered ingredients were initially part of a 1994 tentative final monograph for OTC antiseptic drug products. A 2015 proposed rule called for additional data to support the safety and effectiveness of these ingredients for use in health care antiseptic products. FDA did not receive any additional data, and the available scientific evidence surrounding the ingredients was insufficient to support a determination that they are generally recognized as safe and effective (GRASE).
FDA is delaying final rulemaking for at least one year on benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol (also known as ethanol or ethyl alcohol), isopropyl alcohol, and povidone-iodine. The Agency has stated that a determination for these ingredients will be dependent upon whether ongoing studies are eventually completed, and if so, when they are completed.
Not sure how this rule applies to your health care antiseptics? Registrar Corp’s Regulatory Specialists can conduct a full review of your antiseptic product’s ingredients and labeling. We review your product’s active ingredients to ensure that they conform to the requirements specified in the applicable FDA monographs for antimicrobial drug products. We also inspect your labeling to ensure that its content and formatting conform to numerous FDA drug regulations. In addition to an extensive report of suggested revisions, you will receive a print-ready label incorporating these changes. For assistance, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.
Ingredients Deemed Not Generally Recognized as Safe and Effective under the Health Care Antiseptic Final Rule:orhexidine gluconate
Mercufenol chloride
Cloflucarban
Methylbenzethonium chloride
Fluorosalan
Phenol
Hexachlorophene
Secondary amyltricresols
Hexylresorcinol
Sodium oxychlorosene
Iodophors (Iodine-containing ingredients)
• Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
• Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
• Iodine tincture USP
• Iodine topical solution USP
• Nonylphenoxypoly (ethyleneoxy) ethanoliodine
• Poloxamer—iodine complex
• Undecoylium chloride iodine complex
Tribromsalan
Triclocarban
Triclosan
Triple dye
Combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative
Combination of mercufenol chloride and secondary amyltricresols in 50 percent alcohol
FDA ANNOUNCES NEW ENFORCEMENT APPROACH TO DRUGS LABELED AS HOMEOPATHIC
Once small and specialized, homeopathic drugs now comprise a nearly $3 billion industry. Following an increase in reported health concerns stemming from these products and a flurry of unsubstantiated health claims surrounding the industry, the U.S. Food and Drug Administration (FDA) is taking new measures to curb the widespread distribution of potentially harmful drugs labeled as homeopathic.
What are Homeopathic Drugs?
Homeopathy is a form of alternative medicine based on the principle of remedying health conditions using diluted solutions of substances that produce similar symptoms in a healthy patient.
The Food, Drug, and Cosmetic (FD&C) Act defines articles recognized in the official Homeopathic Pharmacopoeia of the United States as drugs. FDA states that homeopathic drugs “are subject to the same requirements related to approval, adulteration and misbranding as any other drug product.”
Despite this, the uniqueness of homeopathic drugs delayed them from the 1972 over-the-counter (OTC) drug review, which determined the safety and effectiveness of most OTC drugs on the U.S. market. Even now, FDA has not conducted a formal review of homeopathic drugs. Since 1988, a FDA Compliance Policy Guide (CPG) establishes provisions under which these products may be marketed without the prior FDA approval required of other drug products.
Why is FDA Cracking Down on Homeopathic Drugs?
Numerous homeopathic drugs contain potentially harmful ingredients. As recently as September 2017, a homeopathic drug facility received a Warning Letter, citing failure to establish adequate in-process controls for products containing multiple potentially toxic ingredients. One such ingredient was Nux vomica, a plant bearing constituents commonly used for rat poison.
Throughout 2017, FDA issued at least four additional letters to homeopathic drug manufacturers who failed to adequately test and control potentially toxic substances in their products. FDA charged the drugs in question as adulterated.
New Enforcement Approaches to Homeopathic Drugs
In addition to FDA, the U.S. Federal Trade Commission (FTC) has issued measures to mitigate the prevalence of unsubstantiated health claims made by homeopathic drug manufacturers. A 2016 FTC Enforcement Policy Statement requires homeopathic drug labeling to communicate that “there is no scientific evidence that the product works.” The label must also indicate that “the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”
A December 2017 FDA draft guidance explains that the Agency intends to prioritize enforcement on products that are known to cause harm to patients, including those with reported health issues and those deemed adulterated under section 501 of the FD&C Act.
FDA states it will also focus increased attention on homeopathic drugs with less overt health concerns. According to the guidance, unapproved drugs intended to treat serious or life-threatening conditions may cause a patient to delay or discontinue treatment already generally recognized as safe and effective (GRASE). Homeopathic drugs designed for vulnerable populations (e.g. infants and the elderly) may pose significant health risks even in small concentrations, in spite of treatments that have already been determined GRASE. For this reason, these drug categories may see increased regulatory enforcement.
In the previously referenced Warning Letters, FDA maintains that “nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval.” The letters and newly issued guidance suggest that FDA intends to expand efforts to hold homeopathic drug manufacturers accountable to the regulations derived from the FD&C Act.
Registrar Corp is a consulting firm that assists drug companies with U.S. FDA regulations. Our Regulatory Specialists can assist with FDA registration and drug listing, labeling requirements, and other drug regulations. For assistance or questions call +1-757-224-0177.
