Offering nutritional supplements can be an FDA regulatory minefield

Chiropractors are extremely knowledgeable in the field of nutrition, which provides the opportunity to assist our patients in promoting better health through nutrition. Dietary supplements play a crucial role in this goal. If your practice offers supplements, understanding the FDA regulations pertaining to the sale of dietary supplements and stated or implied health claims at the point of sale is crucial.

In 1994, former President Clinton signed the Dietary Supplement Health and Education Act (DSHEA). This act acknowledges that there are millions of Americans who take dietary supplements and believe that these supplements promote better health. The act states that the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented in scientific studies. Congress intended to ensure that manufacturers and consumers had safe products available with the DSHEA . This act also addresses product labels, which must represent claims to assist the consumer in making an informed choice.

Cleaning Up the Act

Congress found that although further scientific research is needed, there may be a positive relationship between sound dietary practice and the reduction of some of chronic diseases, such as cancer, heart disease, and osteoporosis. Also, preventive health measures, including education, good nutrition, and appropriate use of supplements may limit the incidence of these chronic diseases. These measures would reduce health care expenses by mitigating the need for expensive medical procedures, which is paramount to the economic well being of the country.¹

In 1990, congress passed the Nutrition Labeling and Education Act (NLEA), which allows the FDA to approve health claims based on scientific agreement of the validity of the claim. At that time, there were 12 health claims submitted for approval through the NLEA. The FDA approved seven of these claims, most of which were for specific nutrients in foods and not dietary supplements. This fueled charges of bias against supplements.

The FDA proceeded to propose rules that would control implementation of the NLEA. One of these rules was language, which implied intent on the part of the FDA to regulate dietary supplements as drugs. The NLEA provided a framework for diet disease claims that may appear on food labels. These health claims were defined by the FDA as "any claim made on the label or in labeling of a food, including third-party references, written statements of vignettes, characterizing the relationship of any substance to a disease or health related condition."² The definition was so broad that it included almost any symptom related to any condition including natural processes, such as menopause, aging, and pregnancy.

Good Intentions

The intent of the health claims requirement was to ensure truthful and non-misleading claims of the benefits of dietary supplements. In 1993, the FDA commissioner threatened to remove vitamins and herbal products from the marketplace in an attempt to classify them as drugs. The NLEA states that "Vitamins have therapeutic effects when consumed at levels far above those that are normally characteristic of food. When the vitamins are intended to be consumed at these levels to have those therapeutic effects, they are drugs not food." However, the FDA’s attempt to tighten the availability of information and even supplements caused a severe backlash. Congress received more than 200,000 comments on the subject, which resulted in the creation of the DSHEA.

DSHEA affirmed dietary supplements as foods and not drugs. It also affirmed that vitamins were not food additives, which is how some FDA members viewed supplements.

The Food, Drug, and Cosmetic Act, states that foods, including dietary supplements, are presumed safe in the absence of contrary evidence—however, food additives required FDA preapproval. The FDA claimed that some dietary supplements were food additives and pulled them. The current definition of dietary supplements is "foods that include: vitamins, minerals, herbs or other botanicals, amino acids, or other dietary substances for use by man to supplement the diet by increasing the total dietary ingredients or a concentrate, metabolic, constituent, extract intended for ingestion and are not represented for use as a conventional food or a sole item of a meal or the diet and are labeled as a dietary supplement."³

At first, the DSHEA appeared to have a more balanced availability of supplements and the information pertaining to manufacturers. On closer look, it limited health care professionals’ (HCP) ability to sell dietary supplements to patients.

All HCPs who are licensed to treat, diagnose, or prescribe treatment for a disease may supply any helpful, truthful, scientifically supported literature and information regarding dietary supplements. However, once the point of sale becomes a doctor’s office, the HCP is restricted, as are manufacturers, to any health claims—oral, written, or implied. The FDA has ruled that HCPs and manufacturers are restricted to citing the title of a publication or article that refers to a disease when selling the dietary supplement.

For example, claiming there is a reference demonstrating that black cohosh decreases hot flashes constitutes a health claim. Nor may HCPs state that a supplement is better or even as good as a drug. Testimonials constitute a claim. In addition, claims that a product is used or intended for use in countering the effects of a medical treatment are considered disease claims (ie, suggesting patients take probiotics when using antibiotics).

Section 403(r) (6) of the DSHEA specifically provides that statements permitted "may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases," however, these statements may claim a benefit related to a classical nutrient deficiency disease, provided that a prevalence of the disease in the United States is disclosed. Thus, dietary supplements "intended for use in the diagnosis, cure, mitigate, treatment, or prevention of a disease" remain within the definition of a drug.

The FDA’s position stems from the belief that "such claims may encourage consumers to self-treat for a serious disease without benefit of a medical diagnosis or treatment. Claims may also cause consumers to substitute potentially ineffective products for proven ones, foregoing or delaying effective treatment for serious and life-threatening illnesses."

There are 10 criteria for identifying express or implied disease claims that the product:

1. has an effect on a specific disease or class of diseases;

2. uses scientific or lay terminology on one or more signs or symptoms that are recognizable to HCPs or consumers as being characteristic of a specific disease or of a number of different specific diseases;

3. has an effect on a consequence of a natural state that presents a characteristic set of signs and symptoms recognizable to HCPs or consumers as constituting an abnormality of the body;

4. has an effect on disease through one or more of the following factors: name of the product; a statement about the formulation of the product, including a claim that the product contains an ingredient that has been regulated by the FDA as a drug and is well-known to consumers for its use in preventing or treating a disease; citation of a publication or reference, if the citation refers to a disease use; use of the term "disease" or "diseased;" and use of pictures, vignettes, or symbols;

5. belongs to a class of products that is intended to diagnose, mitigate, treat, cure, or prevent a disease;

6. substitutes a product that is therapy for a disease;

7. augments a particular therapy or drug action;

8. has a role in the body’s response to a disease or vector of disease;

9. treats, prevents, or mitigates adverse events associated with a therapy for a disease and manifested by a characteristic set of signs or symptoms; or

10. otherwise suggests an effect on a disease or diseases.

Although it is your constitutional right to free speech, if your practice sells vitamins, you may not make health claims about a supplement unless accepted by the FDA. A reference to a publication during a lecture pertaining to dietary supplements and disease is protected under free speech, but supplements may not be sold at the lecture. Making health claims falls under the restrictions of commercial speech. Commercial speech is considered less valuable than free speech. Under commercial speech, the government prohibits false statements. Speech involving the sale of a substance must be true—dietary supplements fall under this restriction.

However, HCPs may make structure/function claims about dietary supplements provided there is scientific support. The DSHEA allows structure/function claims about natural processes—menopause, pregnancy, and aging. Serious conditions related to these processes, such as fibroids, toxemia, and arthritis, are considered diseases. Structure/function permits claims that a product may relieve a mild condition, such as occasional, but not chronic constipation. In addition, an article may be cited that refers to a disease only if it scientifically supports the structure/function claim and not just a health claim. Supplements that support a process, but do not enhance it (ie, taking antioxidants may support better health) can be suggested.

Although the FDA is more concerned with the major manufacturers of products that make claims regarding health and treatment of disease, HCPs would be prudent to be conscious of the laws and regulations of the DSHEA.

There are a number of health claims that the FDA does allow, which are defined as "any claim made on the label or in labeling a food, including third-party references, written statements, symbols, or vignettes, characterizing the relationship of any substance to a disease or health related condition" (521 CFR No 101.14 (a)(1)(1995). These diet/disease relationships must be approved by the FDA prior to being used on food products. Currently, there are a number of health claims that have been authorized by the FDA:

• calcium and osteoporosis;

• fat and cancer;

• saturated fat and cholesterol, and congestive heart disease (CHD);

• grain products, fruits, and vegetables containing fiber and cancer;

• fruits, vegetables, and grain products that contain fiber and the risk of CHD;

• sodium and hypertension;

• folic acid and neural tube defects;

• sugar alcohol and dental caries; and

• oats and CHD.

Since structure/function claims are not subject to the new drug approval standard or the health claim authorization standard and do not undergo FDA review before marketing, the FDA believes it is important to ensure that such claims do not promote products for disease treatment or prevention claims.⁴

As HCPs, we must work within the confines of the DSHEA ruling. There have been more disease claims approved by the FDA, with more approvals in the future. In 1997, the FDA Modernization Act (MA) expedited the approval process for disease claims. The MA allows food suppliers to notify the FDA of intent to use new health claims based on authoritative statements of one or more federal scientific bodies. If the FDA fails to prohibit or modify the claim within 120 days, the claim can be used. FDA proposed to apply the same principle to claims for dietary supplements.⁵

In January of 1999, the courts reversed the FDA disapproval of four health claims on First and Fifth Amendment grounds. It required the FDA to define and justify "significant scientific agreement"6 when evaluating proposed disease claims and ruled that in the case of conflicting scientific evidence, allowing the claim with a disclaimer was preferable to suppressing the information.

About the Author

Shirley Watson, DC, DACBN, QME, CCN, has a practice in Culver City, Calif, and is a certified clinical nutritionist. She is the former director of education for the American Chiropractic Association’s Council on Nutrition and has written articles on health, nutrition, and the environment. Watson can be reached via email: swatsondc@msn.com.

References

1. Food and Drug Administration. Center of Food Safety and Applied Nutrition. Available at: http://vm.cfsan.fda.gov/~dms/dietsupp.html. Accessed: 1997.

2. Goldberg I, ed. Functional Foods, Designer Foods, Pharmafoods, Nutraceuticals. New York: Chapman & Hall; 1994:294–322.

3. Public Law No. 103–417, 108 Stat. 4329 (1994).

4. Register 65 FR 999. January 6, 1999.

5. Keeler B, Daley JP. Perilous Prescription. Alternative Healthcare Management. 2000;3(2):16.

6. Cohen M. Patients win victory in FDA decision about dietary supplements claims. Alternative Healthcare Management. 1999;2(3):4.