FDA Import Alert No. 66-22:
November 4, 1981
FDA has reviewed the policy issues involved with the detention of homeopathic drugs for failure to bear the prescription legend and failure to bear the statement "for use only by or under the supervision of a licensed practitioner who is experienced in the use of and the administration of homeopathic drugs, and is familiar with the indications, effects, dosages, methods, and frequency of duration of such drugs."
Although FDA has, since the passage of the Durham-Humphrey Amendment, stated in correspondence that homeopathic drugs should be restricted to prescription sale and labeled with the Rx legend, the Agency has never actively attempted to enforce this requirement for domestic homeopathic drugs. We have, therefore, examined the issue from the standpoint of priorities, and we agree that homeopathic drugs of foreign origin should have the same enforcement priority as those of domestic origin. We have also examined the issue from the standpoint of the obligations of the U.S. Government under the General Agreement on Trades and Tariffs (GATT). The GATT requires that imported products "be accorded treatment no less favorable than that accorded to like products of national origin with respect of all laws, regulations, and requirements affecting their internal sale, offering for sale, purchase, transportation, distribution, or use." Although GATT does not prevent signatory countries from enforcing measures necessary to protect the public health, it requires that such measures not be "applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where the same conditions prevail, or a disguised restriction on international trade." Thus, under the terms of this international agreement we cannot act solely against imported homeopathic drugs and leave the domestic products untouched.
The Bureau of Drugs will prepare a surveillance program to determine the current status of the domestic homeopathic industry (e.g., size, products, labeling claims) and the nature of the imported products. The information from that program will be used for an Agency review of our policy on homeopathic drugs and for recommendations to the Commissioner.
Until the Commissioner makes a final decision on both the policy and the priority to be used for all homeopathic drugs, it is not appropriate to detain such imported drugs for failure to bear the prescription legend.
Therefore, homeopathic drugs must be "released with comment" and not detained if they do not bear an Rx legend.
Homeopathic preparations having other types of violations will continue to be detained. These types of violations include:
- Not labeled in English
- Not in compliance with Sections 501 and 502 of the Act
- Not in compliance with the applicable provisions of 21 CFR, Part 201.
To avoid the problem of foreign shippers and importers using this change in enforcement posture as a means of entering various illegal drugs, check to assure that the article is recognized in the Official Homeopathic Pharmacopeia as a homeopathic drug. If the article is an official homeopathic drug and is in compliance with other applicable provisions of the Act and regulations previously cited, but does not bear an Rx legend and/or does not contain the statement "for use only by or under the supervision of a licensed practitioner who is experienced in the use of and the administration of homeopathic drugs xxx" the article should be "released with comment" using the following text comment:
Since the passage of the Durham-Humphrey Amendment to the Federal Food, Drug, and Cosmetic Act (the Act), the Food and Drug Administration has consistently stated in correspondence that homeopathic drugs should be restricted to prescription sale and labeled with the "Rx" legend. This is because we believe that it is inherent in the teaching of homeopathic medicine that both the medicinal agent and dosages employed for treating a disease must be highly individualized for each patient and that adequate directions for lay use cannot be written for homeopathic drugs. In light of competing priorities, however, the Agency has not developed a domestic enforcement program to ensure that homeopathic drugs bear the Rx legend. This regulatory posture has been subjected to review in the past and is now being considered again in light of current marketing practices. Because there has been no domestic enforcement program, we will not at this time detain imported products for failure to bear the Rx legend.
Inherent in the position taken by the Agency in the past correspondence is the requirement that homeopathic drugs meet the following conditions:
- They are labeled with the prescription legend ("Caution: Federal Law Prohibits Dispensing without Prescription.") 21 U.S.C. 353(b) and 21 CFR 201.100(b)(1).
- They are labeled with the statement "For use only by or under the supervision of a licensed practitioner who is experienced in the use of and the administration of homeopathic drugs, and is familiar with the indications, effects, dosages, methods, and frequency of duration of such drugs," which will satisfy the requirements of 21 CFR 201.100(b)(2), (b)(3), and (c)(1).
- They are labeled to comply with all the other provisions of Section 502 of the Act (21 U.S.C. 352) and the applicable provisions of 21 CFR Part 201.
Consequently, the marketing of homeopathic drugs, both domestic and imported, not in compliance with the above, would be regarded as in violation of the Act. However, until the Agency decides to undertake a specific enforcement program, FDA will take no regulatory action against domestic or imported homeopathic drugs which fail to meet items 1 and 2 above if they are otherwise adequately labeled in compliance with other appropriate provisions of Section 502 of the Act (21 U.S.C. 352 and 21 CFR 201. Further, except in instances where a health hazard is identified, any regulatory action taken against homeopathic drugs will be on a class action basis and with adequate notice to the industry. Meanwhile, during this period, the marketing of homeopathic products not in conformance with the above requirements (items 1-3) is done so on a firm's own responsibility, and the products may be at risk at such time as any class action is instituted.
This article was posted on January 8, 2005.