Institute for the Study of
Healthcare Organizations & Transactions

 

LABELING DRUGS AND HERBAL REMEDIES

On January 5, 2000, the Food and Drug Administration (FDA) published its final rule that defines the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body pursuant to the Dietary Supplement Health and Education Act of 1994 (DSHEA).  

While this rule is not expected to affect the availability of dietary supplement products or consumer access to them, it may affect whether certain claims can be made under the 1994 Act.  This in turn may result in some labeling changes for these products (FDA Talk Paper:  FDA Finalizes Rules for Claims on Dietary Supplements.)  See the link in References.

This page will review a brief history of the labeling of drugs and will then focus on the 1994 Act and the most recent developments in the labeling of herbal products and dietary supplements.

 

EARLY HISTORY--1906Labeling drugs 1906 200DPI.jpg (264891 bytes)

In the late 19th and early 20th centuries, the food and drug marketplace was so corrupt that some states began to hire their own chemists to certify the quality and purity of foods and drugs sold within their states, and to defend against the sale of adulterated and inferior foods and drugs from outside. A few states passed sweeping laws, but there was little agreement on standards for foods and drugs. In addition, these laws typically punished retailers, although in many instances, manufacturers were the greater problem.

Drug companies wielded substantial influence, especially those in the patent medicines industry. There was little to stop patent medicine makers from claiming anything and putting anything in their products. In fact, by the 1890s patent medicine manufacturers used so-called "red clauses" in their advertising contracts with newspapers and magazines. These muzzle clauses voided the contract if a state law regulating nostrums (a medicine whose ingredients are kept a secret) was passed. Thus, not only were many editorials silent on the need for such laws, they actively campaigned against them. 

But the nostrum makers were not able to stifle the entire fourth estate. A few muckraking journalists helped expose the red clauses, the false testimonials, the nostrums laden with arsenic and other harmful ingredients, the unfounded cures for cancer, tuberculosis, syphilis, narcotic addiction, and a host of other serious as well as self-limited diseases. The most influential work in this genre was the series by Samuel Hopkins Adams that appeared in Collier's on October 7, 1905, entitled "The Great American Fraud."

More than anyone else, Harvey Wiley, head of the Bureau of Chemistry of the U.S. Department of Agriculture, led the way toward consumer protection. He worked tirelessly for decades to consolidate the efforts of state food and drug officials, the General Federation of Women's Clubs, and pharmacists toward a comprehensive federal law. That law, the 1906 Pure Food and Drug Act, prohibited interstate commerce in adulterated or misbranded drugs. It required that the presence and amount of selected dangerous or addicting substances, such as alcohol, morphine, heroin, and cocaine, had to be labeled. It also identified the United States Pharmacopeia and the National Formulary as official standards for drugs.  

(The above text and illustration were adopted from a poster on display at the Pharmacy Museum in New Orleans, Louisiana.  The poster is from a traveling exhibit that was one product of a 1996 symposium entitled "Medicines:  The Inside Story".  For more information contact the museum in New Orleans at 504.565.8027.)

 

DRUG LABELING EVOLUTION I

Drug Labeling Evolution 1.jpg (27677 bytes) The 1906 law that was discussed above fell short of providing the protection that Congress intended in that the misbranding provision in the law did not prevent false or misleading efficacy claims.  Some drug manufacturers, fearing a violation of the labeling provision, simply omitted such information from the label, since the act did not require the label to list the ingredients, include directions for use, or provide warnings.  As a result of a 1911 court case, Congress decided to amend the Pure Food and Drug Act in 1912.  However, even with this amendment, the act failed to achieve its purpose because it was difficult to enforce.  The amendment required the government to prove fraudulent intent on the part of anyone who made false statements on a label.  All violators needed to do to escape prosecution was to plead ignorance.  Although the Congress understood that the 1906 Act and its subsequent amendment were inadequate, there was no new legislation until 1938. 

A catalyst for the Food, Drug and Cosmetic Act of 1938 was the sulfanilamide elixir tragedy of 1937. Sulfanilamide, considered to be an early "miracle" anti-infective sulfa drug, was manufactured in an elixir form using diethylene glycol as the solvent.  (Diethylene glycol is used as an automotive antifreeze today.)  No toxicity tests had been conducted and 107 people died after using this elixir.  

(The source for this information was Abood and Brushwood (1994).  See  References  in order to obtain more information on this book. The illustration was adopted from a poster on display at the Pharmacy Museum in New Orleans, Louisiana.  It is from a traveling exhibit that was one product of a 1996 symposium entitled "Medicines:  The Inside Story".  For more information contact the museum in New Orleans at 504.565.8027.)

 

DRUG LABELING EVOLUTION II

The 1938 law improved on many of the label shortcomings of the 1906 act. For example, it mandated complete listing of ingredients, and it required that drugs be labeled with adequate directions for safe use. The adequate directions mandate affected both the consumer and the prescriber of drugs. The FDA's decision in Drug Label Evolution II.jpg (88375 bytes)1938, that some drugs simply were too dangerous for labeled directions to the consumer, led to the requirement that such drugs be labeled for prescription distribution only.  By 1940, the FDA had developed over two dozen warning statements for different drugs intended for sale directly to the public.  

In 1951, the Durham Humphrey Amendment (also referred to as the Prescription Drug Amendment) was passed which provided that the labels of prescription drugs need not contain "adequate directions for use" so long as they contained a legend: "Caution: Federal law prohibits dispensing without a prescription."  When dispensed by a pharmacist, inclusion on the label of directions from the prescriber satisfies the "adequate directions for use" requirement.  As a result of this Act, two classes of drugs came into existence:  prescription and over-the-counter (Abood and Brushwood, 1994).

That a drug was transferred to prescription use did not invalidate the need for adequate directions for use, which FDA required the manufacturer to make available to the prescriber, often in the form of a package insert. The law exempted investigational new drugs from these labeling provisions.

Most of the basics of a drug label--such as the listing of ingredients and directions for the patient and the prescriber of drugs were established in the first half of the 20th century, but that is not to say the latter half of the century was without important developments. Consumer information on both over-the -counter and prescription drugs has increased substantially over the past few decades. In 1970 FDA issued regulations requiring oral contraceptives to provide patients with information about their use--the beginning of patient package inserts for prescription drugs. In 1995 FDA announced a program to provide patients with more information about all their prescriptions through standardized literature, or "medguides" provided by pharmacists. A year earlier the agency introduced prototypes for over-the-counter drug labels in an easy-to-read format.

(The above text and illustration were adopted from a poster on display at the Pharmacy Museum in New Orleans, Louisiana.  The poster is from a traveling exhibit that was one product of a 1996 symposium entitled "Medicines:  The Inside Story".  For more information contact the museum in New Orleans at 504.565.8027.)

 

The Dietary Supplement Health and Education Act of 1994 (DSHEA)

Herbal Bottles.jpg (34757 bytes) Under this Act, dietary supplements may bear "structure/function" claims without prior FDA review.  These are merely claims that the products affect the structure or function of the body.  However, dietary supplements may not bear a claim that they can prevent, treat, cure, mitigate or diagnose disease without prior FDA review.  These types of claims are known as "disease claims".  

As a result of this Act, most herb products are now sold in a food category designated "dietary supplements."  The legislative intent of DSHEA was to guarantee availability of herbal products, to allow  scientific information, that is truthful and appropriately qualified, to be used in conjunction with the sale of these products, to give consumers some information about the products' benefits, and to provide appropriate cautions about their use.  The Act also places the burden of proof that an herb product is adulterated or unsafe on the government.  The government is now required to present any such evidence in federal court rather than simply ordering the manufacturer to stop selling the product.

This Act permits what is known as "third-party literature", although what exactly constitutes this type of literature has yet to be defined in a regulatory context.  In theory, publications, articles, chapters in books, and scientific reports to support the sale of dietary supplements is permitted and is not considered "drug" labeling.  However, the information must not be false or misleading and must not promote a specific manufacturer or product brand.  It must provide a balanced view of any scientific research.  In addition, if information is displayed in a store, it must be kept separate from the dietary supplement to which it refers.  

Finally, this Act allows labels to discuss the effects on general well-being or on "structure or function in humans" but drug claims cannot be made.  If the labels carry structure or function claims, the label must also carry the following disclaimer:  This statement has not been evaluated by the Food and Drug Administration.  This product is not intended to diagnose, treat, cure, or prevent any disease.

(Much of the information in this section was derived from the discussion in Tyler's Honest Herbal.  See References. The illustration is from the New York Times, February 9, 2000.

 

New Rules for Claims on Dietary Supplements

These rules which became effective on February 7, 2000 attempt to distinguish the "disease claims" from the "structure/function claims" that were articulated in the 1994 Act.  If a dietary supplement claims to cure a disease, it must undergo rigorous FDA review prior to making it available to the public.  This process would be similar to that used for prescription drugs.  If a dietary supplement does not claim to cure a specific disease or malady, it does not have to undergo rigorous FDA review.  Supplement makers would want to avoid FDA review in order to market their products more quickly to consumers.  The key to the distinction is the language that is used to describe what a supplement actually does (according to manufacturer).  Some examples are provided below.

         Structure/Function Claims                                     Disease Claims

Maintains healthy lung function Maintains healthy lungs in smokers
Supports the immune system Supports the body's antiviral capabilities
Helps to maintain cholesterol levels that are already within the normal range Lowers cholesterol
For the relief of occasional sleeplessness Helps to reduce difficulty falling asleep

 

In all, the FDA came up with many such examples of acceptable and unacceptable language, from both real and hypothetical labels, which were derived from comments by consumers, advocacy groups and supplement makers. 

The FDA acknowledges that the differences between acceptable and unacceptable claims may be hard to discern and has been referred to "splitting hairs".  These new rules may not be the last word on this subject.

(The information for this section was adopted from an article in the Wall Street Journal, February 22, 2000.)

References

Abood, R.R., & Brushwood, D.B. (1994). Pharmacy practice and the law. Gaithersburg, MD:  Aspen Publishers, Inc.

Adams, C. (2000, February 22). Splitting hairs on supplement claims.  The Wall Street Journal. pp. B1, B4.

Brody, J.E. (1999, February 7). Americans gamble on herbs as medicine.  The New York Times, pp. D1, D7.

Food and Drug Administration. (2000, January 5). FDA finalizes rules for claims on dietary supplements [On-line] Available:  http://vm.cfsan.fda.gov/~lrd/tpdsclm.html.

Foster, S. & Tyler, V.E. (Eds.) (1999). Tyler's honest herbals. New York: The Haworth Herbal Press.

 

Lucy Canter Kihlstrom, PhD
Copyright 2000 Institute for the Study of Healthcare Organizations & Transactions.  All rights reserved.
Revised: April 08, 2010 .