FDA’s Ed Miracco Remarks — As True Today As in 1998
Reprinted from AAHP NetworkNews November 1998
The following are excerpts of the remarks made in 1998 by Ed Miracco (US FDA) to AAHP members and guests at the association’s 75th Anniversary Celebration. Although over a quarter century has passed, these remarks are strikingly similar to today’s thoughts at FDA. They are reprinted here to show FDA’s thinking really hasn’t changed much over the past 25 years. [Emphasis has been added regarding certain points regarding FDA’s perspective about which some mis-information has recently been circulated.]
“I want to thank the American Association of Homeopathic Pharmacists for inviting me here today to speak on behalf of the Food and Drug Administration and its regulatory role concerning homeopathic drugs.…
“In 1938, the current FDCA was passed in Congress and signed into law. The Act, in section 201G1A, defines a drug in relevant part as ‘articles recognized in the official Homeopathic Pharmacopoeia of the United States.’ Section 201J of that Act, defines the Homeopathic Pharmacopoeia of the United States as ‘an official compendium.’ These two sections are extremely important as they form the basis of regulating homeopathic products: helping to identify homeopathic products as drugs and giving official recognition to the homeopathic pharmacopoeia.…
“… In relation to … section 201GA, (which defines a drug as an article recognized in the HPUS), the definition of a drug also includes in section 201 G1B of the FDCA: ‘articles intended for use in the diagnosis, cure, mitigation , treatment and prevention of disease.’
“Because the intended use of homeopathic products is treatment of conditions of diseases, it also clearly follows that any product claiming to be homeopathic is also a drug. This is irrespective … of whether it claims to be a food or a cosmetic. From FDA’s perspective there is no such thing as a homeopathic food or cosmetic.
“We have found that many of our regulatory efforts and actions have to do with homeopathic products that are marketed over the counter but which bear therapeutic claims that cause these to be prescription drugs. For example, we have seen homeopathic products intended for OTC [sale] for such specific disease conditions as cancer, diabetes, infertility, impotence, anorexia, bulimia, Lyme disease, stroke and cardiac arrhythmias. We have also seen indications for use for serious disease which are described in more general terms such as: ‘liver disorders’ and ‘lymphatic disorders’ and ‘circulatory disorders.
“Essentially, when a drug is intended for disease or a condition which is not amenable to self-diagnosis and treatment by the lay person, and therefore cannot be used safely other than under the care and supervision of a licensed medical practitioner – it is a prescription drug. As a prescription drug, it must abide by section 503 of the FDCA which requires that it be dispensed pursuant to a prescription of a licensed practitioner and that its’ label include the statement RX only.…
“Another issue which has generated our concern is the absence of tamper-resistant packaging and labeling for OTC drugs fit for retail sale. We’ve seen a number of products that lack adequate tamper resistant packaging and/or proper labeling as described in 21 Code of Regulations 211.132.
“Another difficulty we have encountered in our review of homeopathic product labeling is the declaration of ingredients by common names that we cannot find anywhere. We use our homeopathic reference sources including, of course, the HPUS, various Materia Medica (including Dr. John Henry Clark’s Dictionary of Practical Materia Medica). If we can’t find the name, we run into a dilemma because the burden falls on the marketer to prove that the product is homeopathic.
“If the marketer cannot prove that the product is homeopathic then the product is not homeopathic -- because you cannot have a mixture of homeopathic ingredients with non-homeopathic active ingredients…. So, to avoid this problem, make sure that the ingredients that you declare on the labels can be found in one of these reference sources. Or make sure you have the supporting documentation that the ingredient is homeopathic if the ingredients are not found in one of our reference sources.
“We’ve also found a few products in the market which bear vague and general claims that may unintentionally encompass serious disease conditions. For example, a product indicated for gastrointestinal disorders without further clarification or qualification can mean that a product is to be used for indigestion, or stomach aches, or colon cancer. So you have to be careful that your indication for use is not too broad nor too vague or too general. Your indications for use should be as specific as possible.
“In a similar vein, we have seen words such as “minor” or “temporary” that are used to describe liver disorders, lymphatic disorders. We are not familiar with any liver or lymphatic disorders which are minor or temporary – certainly none that laymen can treat themselves. So you have to be careful of that as well.…
“Finally -- the disparate treatment of the homeopathic drugs by the Food and Drug Administration. Over the years the FDA has regulated homeopathic drugs in several significantly different ways. This disparate treatment has been primarily based on the uniqueness of homeopathic drugs, the expectation that these products have little or no pharmacological active ingredients, and because of Agency resources and priorities. For example, the FDA, as a policy, has not required the submission of New Drug Applications for homeopathic drugs. For this reason, marketers of homeopathic drugs, at this point in time, need not submit New Drug applications for their homeopathic products….
“But bear in mind, that it is a policy. I have heard, on many occasions, people say to me that it’s law, what Congress intended – things like that. This is simply a policy of the FDA. According to the FDCA, all drugs, irrespective of whether they are homeopathic or not, require New Drug Applications. I should not say this quite as blankly; there are instances where that is not the case. For example, in the OTC review process, a New Drug Application is not required if the Agency, through its expert panel, decides that a product is indeed safe and effective based on the evidence that has been submitted – not as part of a new drug application. But [rather] what we’ve found on our own in many instances.
“Homeopathic products are not being examined as part of the on-going OTC drug review process. In the Federal Register of May 11,1972 (when the OTC review process began), the Commissioner of FDA responded to a request from the American Institute of Homeopathy stating, in Comment number 25, that homeopathic drugs would be excluded from the current OTC drug review. The Commissioner further stated that homeopathic drugs would be reviewed after the OTC drug review was completed. That OTC drug review continues to this day; it has been on-going for 26 years. The light appears to be at the end of the tunnel. I’m told we’ve gotten about 80 per cent of the way through. I don’t know how long the remaining 20 percent will take, but I’m sure it is a minimum of several years off.
“Homeopathic drugs are exempt from certain portions of the Good Manufacturing Practices for drugs. 21CFR211.137 exempts homeopathic drugs from expiration dating. The Federal Register of April 1, 1983 announced a proposed modification to 21CFR211.165 that exempts homeopathic drugs from finished product testing and for identity and strength. [*] And 21CFR211.166 requires modified stability testing for homeopathic drugs (when you compare it to the stability testing that is required for non-homeopathic drugs).…
“Homeopathic drugs must abide by modified solid oral dosage form imprinting requirements. 21CFR206.10 states that the imprint required for homeopathic solid oral dosage form drugs must identify the manufacturer or the distributor and the homeopathic nature of the drug. (The imprint on other solid oral dosage form drugs, in conjunction with the product’s size, shape and color must identify the manufacturer or distributor as well as the specific active ingredient and dosage strength.) 21CFR328.10 currently exempts homeopathic drugs from the alcohol content requirements for OTC orally ingested drugs. And, finally -- the last regulation -- a proposed rule in the Federal Register of 2/27/97 exempts homeopathic drugs from the standardized labeling format for OTC drugs.…”
[* Note: this proposed modification was subsequently withdrawn.]