Herbals look too much like drugs, says AMA
that of drugs, according to the American Medical Association (AMA),
which is campaigning for a change in labeling, packaging and
advertising regulations to make the distinction clear, reports
Jess Halliday.
At its Annual Meeting last week, AMA's House of Delegates adopted a resolution to encourage the inclusion of the word 'herbal' in the names of herbal supplements, and to discourage them from being packaged and advertised in such a way as to resembles the packaging and advertising of prescription drugs.
Under the Food, Drug, and Cosmetic Act, dietary supplements are required to be labeled either using the term 'dietary supplement', or an appropriate alternative that accurately reflects the ingredients, such as 'herbal supplement'.
Their labels are also required to carry an ingredient list and a 'Supplement Facts' panel similar to the 'Nutrition Facts' panel displayed on conventional foods.
The enforcement of these regulations by the FDA was recognized by the AMA at the meeting, an admission that caused it to retreat from two of the points in the proposed resolution: that AMA should "work with the appropriate agencies to strengthen regulations regarding the advertising and distribution of herbal supplements"; and to "encourage the Food and Drug Administration to require that all herbal supplements carry an ingredient list similar to that required for foodstuffs and pharmaceuticals".
Michael McGuffin, president of the American Herbal Products Association (AHPA) told NutraIngredients-USA.com that the resolution strikes him as "an action that was made in ignorance of the actual law".
"I am not convinced that the word 'herbal' sounds less like the word 'pharmaceutical' than 'supplement' does," he said.
"The AMA is not giving any credit to the intelligence of the consumer, assuming that adults cannot tell the difference between a vitamin or a herbal tincture and a drug."
A document on AMA's website explaining the reasoning behind the proposal of the resolution by the Tennessee delegation draws attention to the marketing strategy of Berkeley Premium Nutraceuticals, which it says has chosen to label its herbal supplements to sound like prescription medications without reference to what herbs and vitamins are contained in them, such as Altovis, Avlimil Complete, Dromias and Enzyte.
It also criticizes Berkeley for its television advertisements, which it says emulate those for prescription medicines, and for its use of blister packaging cycles that are commonly used as medication packaging.
AMA did note that the resemblance of some herbal supplements packaging to that of over-the-counter drugs might be because both are designed with safety in mind.
In cases where taking too many herbal supplements may present a health risk, it would clearly be nonsensical to lower the safety standards by, for example, prohibiting them from being sold in child-proof containers.
In fact, it is mandatory that some supplements, such as iron, are packaged in child-proof containers.
The new resolution builds on an existing policy, H-150.954, which includes encouraging physicians and the public to report potential adverse events associated with dietary supplements and herbal remedies, and urging Congress to modify the Dietary Supplements Health and Education Act (DSHEA) in certain key respects.
It wants to see all dietary supplements, including those already on the market, approved by the FDA for safety and efficacy. At present, the FDA only required notification of new dietary ingredients that were not used in products on the market prior to October 15 1995.
It also wants dietary supplements to have to meet United States Pharmacopeia standards on identity, strength, quality, purity, packaging, and labeling, and wants legislation to be developed and enforced that declares metabolites and precursors of anabolic steroids to be drug substances, prohibiting their use in dietary supplements.
While industry trade associations such as AHPA support the need for serious adverse effects reporting, they argue that DSHEA is a good law, and is effective when fully implemented.
McGuffin pointed out that adverse effects reporting for drugs by doctors is not mandatory, something that clearly falls within AMA's campaigning remit.
"I invite AMA to see what it requires to get doctors to report adverse effects to health authorities," he said.
