When Does a Vitamin Become a Drug?

When Does a Vitamin Become a Drug?

 

Over the past few weeks I have had some opportunities to discuss the role of vitamins vs. Rx and OTC drugs in the mitigation of disease. There seems to be some confusion with respect to the definition of these terms and how they are regulated. With that in mind:

 

The definitions and interpretations contained in this paper are valid for use in the United States only.

 

Drugs, for the purpose of this discussion, may be defined as chemical substances usually not found in nature in the same way they are found in drugs, that may be used to diagnose, treat, cure or prevent a disease. The term disease refers to, and is sometimes called, a “medical condition.” Disease may be defined as deviation from the normal structure or function of a tissue or organ such that damage or injury results.

 

The term “vitamins” as used in this article include vitamins, minerals and other “natural” substances including herbs. These are generally chemicals found in nature that are found in vitamin products in virtually the identical chemical configuration. Generally these are substances that the body needs for growth, repair, or to defend itself from diseases related to nutritional deficiency or in the case of certain herbs, as folkloric treatment of medical conditions.

 

Broadly speaking, drugs have a therapeutic application with respect to disease, and vitamins have a nutritive application with respect to maintaining normal, non-disease impeded functions.

 

From this it would seem that there is little chance of confusing drugs and vitamins. The difficulty lies not with the drugs or vitamins per se, but how they are positioned for sale, how they are traditionally used and how they are regulated.

 

Under federal law including but not limited to 21CFR and the Food Drug and Cosmetic Act , a claim that a substance diagnoses, treats, cures or prevents a disease automatically makes that substance a drug (or in some cases a medical device) subject to approval and ongoing regulation by FDA, irrespective of its origin, application or traditional use.

 

Here are a few ways in which naturally occurring substances, vitamins, change regulatory status so as to become drugs:

 

CLAIMS:

A vitamin becomes a drug for regulatory purposes when the seller of the vitamin, or in some cases a third party, makes a claim that the vitamin diagnoses, treats, cures or prevents disease. A statement that Vitamin C may shorten the duration or severity of a cold could make vitamin C a drug. In fact some years ago Linus Pauling Ph.D., published a book titled “Vitamin C and the Common Cold.” Health food stores were not allowed to sell vitamin C in proximity to the book because, under the theory of 21 CFR, the vitamin became a drug when in the presence of Pauling’s book.

 

Graphic representations may be viewed as claims. If, for example, a vitamin bottle displayed a label that pictured an electrocardiogram, the product could be categorized as a drug since electrocardiogram tracings would normally be associated with a medical diagnostic procedure. Moreover, since the general public would be unable to distinguish between normal and abnormal tracings there may be an assumption that the labeled product was appropriate treatment for cardiovascular disorders.

 

Testimonials from vitamin users, when displayed on the vendor’s promotional material are considered product advertising claims.

 

COMPARISONS:

A vitamin becomes a drug when the seller of the vitamin compares its health benefits with the health benefits of a drug. For example, if a supplement manufacturer claims that his herbal product reduces “LDL cholesterol” and/or “produces an effect like Lipitor™.” The herbal combination is held to be a drug because Lipitor™ is a drug and favorable comparison of therapeutic capability makes the vitamin a drug.

 

Even if the Lipitor™ name is not invoked, the product may still be considered a drug if regulators feel the promises of reduction of LDL cholesterol constitute a disease-mitigating claim. See Net Takeaway, below.

 

ROUTE OF ADMINISTRATION

A vitamin becomes a drug when the route of administration is other than the digestive system. Vitamins are “dietary supplements” and since food is processed through the digestive tract, the dietary supplement must be administered and processed the same way. A vitamin B product that was to be absorbed through the nasal mucosa was held to be a drug because route of administration was not dependant on the digestive tract. A vitamin designed to be held under the tongue and absorbed “sublingually” is a drug because it gets into the users’ blood without gastrointestinal uptake.

 

POTENCY:

A vitamin may become a drug when the potency or strength of the vitamin exceeds certain levels. The mineral potassium is a dietary supplement when present at levels of 99 mg (elemental) or below per serving, but once the level reaches 100mg or above per serving the mineral becomes a drug. The usual reason for limiting OTC dosages is related to the capacity of some vitamins and mineral at high levels, to interfere with the uptake of other nutrients or Rx drugs.

 

INHERIENT DANGER:

A vitamin may become a drug if its active ingredients present a conspicuous risk to the general public. A naturally occurring herb may be categorized as a drug if it has a history of creating undesired effects, or it may be banned altogether. Belladonna is an example of a naturally occurring substance that has the potential for harm when used promiscuously. Thus it is regulated as a drug.

 

NET TAKEAWAY:

In certain situations a vitamin product may be declared to be a drug even if none of the specific conditions describe above are in evidence. Federal Trade Commission may decide that the product advertising implies medical palliation or that a reasonable person may infer such a promise even though no such language overtly appears in the label or advertising for the product. FTC and other agencies evaluate the net takeaway message, not just the specific terminology.

 

The regulatory position that only drugs can cure disease is irrational, but no one ever said life was rational.