Management on sanitary inspection behind quality of foodstuff and medicines of the Ministry of health and social services of the United States is tightening controls in relation to homeopathic products. In draft guidance posted online for public review, the proposed new approach. It is based on assessing risks to consumer health.
The document is intended to update the policy in relation to homeopathic medicines. In the risk category in respect of which the Agency sets the priority of regulatory action, get the drugs:
– the data on security issues;
– containing or claiming the content of substances that are potentially dangerous;
– having a route of administration that is different from oral and local application;
– intended for the prevention or treatment of serious and/or life-threatening diseases and conditions;
– designed for vulnerable populations;
– does not meet the standards of quality, purity and content of active substances, as required by law.
Examples of such products are products for babies and children that are labeled as containing belladonna and Nux-vomica and homeopathic medicines intended for the treatment of cardiovascular diseases and cancer.
As indicated in the statement of the regulator, the market for homeopathic medicines is estimated at $ 3 billion. It carries the potential risks of a large number of consumers associated with the use of unproven and not validated by action.
During this time FDA registered the increase of security problems, including serious adverse reactions associated with the use of homeopathic medicines and their content of potentially hazardous substances. So, in September 2016 the FDA warned about the content of the belladonna in the tablets and gel for teething laboratory analysis showed an uneven and sometimes exceeding the maximum allowable level of the substance. A similar problem occurred in 2010 – check production sites showed deviations from the regulated standards of quality control.
The Agency issued a warning related to the security of a number of other homeopathic remedies: of zinc-containing products that cause a loss of smell, asthma homeopathic remedies, which has been shown to be not effective in the treatment of the disease.
In addition, in November 2016 of the Federal trade Commission ordered manufacturers of homeopathic products indicate on the packaging and promotional materials that there is no scientific evidence that the product works or to provide competent and reliable evidence to refute this fact.
As noted by FDA Commissioner Scott Gottlieb, in many cases, people invest trust and money in therapy, which is of little use in the fight against serious diseases, or worse, causes significant and irreparable harm. The Agency respects people’s desire to use alternative therapies, but the FDA is responsible for protecting the public from products that are harmful or not beneficial to the consumer.in in homeopathic abletech
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