Will the Recent Scientific Attack on Vitamin Use Spawn a New Wave of False Advertising Litigation?
For centuries, we’ve ingested magic elixirs in pill and syrupy forms to cure whatever ails us and to ward off future illness. Hard scientific evidence of efficacy may have been lacking for these nostrums, but lingering doubts fell sway to the testimonial charms and hard-sell tactics of proverbial snake oil salesmen. Once operating door-to-door, these smiley faces are nowadays more likely to be wearing white lab coats in glossy advertorials. [1]
“Enough is Enough”
A recent headline-generating editorial in the Annals of Internal Medicine calls into doubt the health value of taking daily multivitamins and mineral supplements—the sacred cow of the over-the-counter pharmaceutical world; the pablum we mindlessly swallow believing it’s good for us. The Annals editorial authorsproclaim: “Enough Is Enough: Stop Wasting Money on Vitamin and Mineral Supplements.”[2] Their survey of study results concluded with this emphatic statement:
[W]e believe the case is closed—supplementing the diet of well-nourished adults with (most) mineral and vitamin supplements has no clear benefit and might even be harmful. These vitamins should not be used for chronic disease prevention. Enough is enough.
Even worse, it turns out that consuming some vitamins or minerals in supplement form may be downright harmful. The editorial further states that “[i]n conclusion, β-carotene, vitamin E, and possibly high doses of vitamin A supplements are harmful. Other antioxidants, folic acid and B vitamins and multivitamins and mineral supplements are ineffective for preventing mortality or morbidity due to major chronic diseases.”[3]
Food vs. Dietary Supplements vs. Food Additives vs. Drugs
Dietary supplements occupy a curious nether world of regulation in the continuum that distinguishes “food”[4] on the one hand, and “food additives” and “drugs” on the other. When marketers ascribe curative “healing” powers to food and dietary supplements—i.e., statutorily defined as vitamins, minerals, herbs or other botanical substances, amino acids or combinations or concentrates of these forgoing substances—an unsubstantiated choice of words regarding curative health benefits can instantly transform a food or dietary supplement into a “drug” under the Food, Drug and Cosmetic Act of 1938, as amended.[5]
The term “drug” includes “articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals” per 21 U.S.C. §321(g)(1)(B). A “drug” generally must undergo expensive randomized, double-blind testing to demonstrate efficacy before the drug can be sold to the public.[6] A “food additive”—i.e., a substance which is expected to become a component of food or otherwise affect the characteristic of foods—can only be introduced into the market if the substance is generally recognized as safe by qualified scientific experts or has been commonly ingested in the food chain since prior to 1958. Dietary supplements are specifically excluded from the definition of a “food additive.”[7] Thus, dietary supplements do not have to undergo such pre-market testing before being ingested by the public.
The False Advertising Implications of the Annals Editorial
For vitamin and mineral supplement manufacturers, the Annals of Internal Medicine editorial throws down a gauntlet for false advertising litigation purposes. Pursuant to the Dietary Supplement Health and Education Act of 1994 (DSHEA) [8], and its predecessor, the Nutrition Labeling and Education Act of 1990 (NLEA), a purveyor of a dietary supplement can claim “preventative” health benefits associated with its ingestion, such as describing (a) the role of the dietary supplement in addressing a nutritional deficiency, (b) how it affects the structure or function of our human anatomy, or (c) how it impacts our general well-being. See21 U.S.C §343(r)(6).
Under the DSHEA, the FDA “may not establish maximum limits on the potency of any synthetic or natural vitamin or mineral within a food” and “may not classify any natural or synthetic vitamin or mineral (or combination thereof) as a drug solely because it exceeds the level of potency which the [FDA] determines is nutritionally rational or useful . . . .” 21 U.S.C. §§350(a)(1)(A) and (a)(1)(B).
Whither the Scientific Substantiation
for Dietary Supplement Health Claims?
Whenever manufacturers or distributors tout “preventative” health claim benefits for ingesting a dietary supplement, they must have scientific substantiation that the claim is truthful and not misleading. While the DSHEA does not define what constitutes proper or sufficient substantiation for dietary supplement health claims, the FDA and FTC generally require “tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that [have] been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”[9]
By way of example, even a casual review of Internet advertisements for beta-carotene shows that dietary supplement manufacturer health claims appear to be out of sync with an emerging scientific consensus that ingesting too much beta-carotene can be detrimental to your health and well-being. For example, a website page for beta-carotene dietary supplements states that:
Beta-Carotene is a carotenoid that readily converts to vitamin Ain your body when needed.**
Beta-Carotene supports eye health.**
Beta-Carotene supports antioxidant health and immune health by helping to fight free radicals.**
Beta Carotene is essential for healthy skin and hair.**
Unlike Beta-Carotene, fewer than 10% of other carotenoids convert into vitamin A.
This advertisement includes a disclaimer (marked by the double asterisks) that “These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.” [10]
The beta-carotene advertisement does not include any disclaimer or qualification that would notify the consumer regarding the potential negative health implications of ingesting beta-carotene as a dietary supplement. It implies that taking beta-carotene only brings health benefits as a universal good. However, the scientific consensus regarding beta-carotene is best summarized as follows:
There are many authorities – including the American Heart Association, the American Cancer Society, the World Cancer Research Institute in association with the American Institute for Cancer Research, and the World Health Organization’s International Agency for Research on Cancer – that recommend getting beta-carotene and other antioxidants from food instead of supplements, at least until research finds out whether supplements offer the same benefits. Eating 5 servings of fruits and vegetables daily provides 6-8 mg of beta-carotene.[11]
Because the scientific consensus undermines the asserted benefits of ingesting beta-carotene and other vitamins or minerals in supplement form, purveyors of dietary supplements may well soon find themselves named as defendants in false advertising claims brought by the FTC or by crafty class action plaintiffs. False or misleading statements about dietary supplements can give rise to non-preempted, private rights of action under state law unfair competition and deceptive trade practice laws.[12]
An analogous type of FDA-based false advertising claim is discussed in the Federal Circuit Court of Appeals decision in Allergan, Inc. v. Athena Cosmetics, Inc.(decided on December 30, 2013). Athena sells a “RevitaLash” line of products that contains a prostaglandin derivative as its active ingredient. However, no new drug application had been submitted for this line of products. The active ingredient in this product amounts to a “new drug” subject to FDA pre-market approval. Athena violated FDA requirements by marketing and selling its “RevitaLash” line of products before undergoing that clearance/approval process. Because California incorporates FDA laws into its Health Code, Athena’s FDA violation gave rise to a non-preempted, private right of action under California’s unfair competition laws. Athena’s liability was so clear cut that it was liable for false advertising as a matter of law.
It is important to take the Annals editorial with a grain of salt. Its broadside against taking multivitamins itself deserves further qualification. As Darya Rose—a self-described neuroscience PhDork and food and health writer—aptly observes in her excellent food blog, Summer Tomato, “I think they overstate the case against a basic multivitamin. I can think of dozens of potential benefits they did not test for (e.g. immunity, fatigue, etc.), and very few of us can eat a perfectly balanced diet every single day. I continue to recommend a food-based multivitamin . . . that does not contain megadoses of any single nutrient.”[13]
Conclusion
As some early DSHEA commentators foretold, distinguishing dietary supplement health claims “from ‘drug claims,’ which allege to diagnose, cure, mitigate or prevent a disease and thereby render the product a drug (and not a dietary supplement) poses one of the most difficult challenges for marketers of dietary supplements . . . .”[14]
With scientific substantiation eroding with respect to the supposed efficacy of ingesting certain vitamins and minerals, dietary supplement marketers are skating on very thin legal ice if they continue to advertise and promote the health benefits of taking certain vitamin and mineral supplements without including prominent disclaimers or qualifications regarding potential negative health implications. Since the U.S. dietary supplement industry reached $28 billion in sales in 2010, this industry could serve as a deep pocket for funding the attorneys’ fees recoverable byprevailing parties in false advertising cases.
[1] The advertisement for “Mrs. Winslow’s Soothing Syrup” that appears at the beginning of this article on Lane Powell’s Earth and Table website is one of the most popular advertisements of the 19th and early 20th centuries. These ads claimed that the syrup had “magical effects and medical virtues” and that Mrs. Winslow was an experienced nurse. The syrup contained one grain of morphine per fluid ounce, and also sodium carbonate, spirits foeniculi, and aqua ammonia. Kids who did not overdose on it often became addicted to morphine. It was banned for sale in the U.S. in 1906. See “Patent Medicines & Miracle Cures” (September 2011) available online at http://www.nycbar.org/library/featured-exhibitions/patent-medicines-and-miracle-cures.
[2] An article about this editorial can be found at http://disinfo.com/2013/12/enough-enough-stop-wasting-money-vitamin-mineral-supplements/. The editorial article itself may be purchased from the website, http://annals.org.
[3] “Enough is Enough: Stop Wasting Money on Vitamin and Mineral Supplements,” 159 Annals of Internal Medicine No. 12, pp. 850-51 (December 17, 2013).
[4] “Food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. 21 U.S.C. §321(f).
[5] The complete definition of a “dietary supplement” is very detailed and set forth in 21 U.S.C. §321(ff).
[6] Randomized, double-blind testing means that neither the subjects of the experiment nor the persons administering the experiment know the critical aspects of the experiment. Such testing seeks to prevent experimenter bias and placebo effects from subtly influencing experimental test results.
[7]See 21 U.S.C. §321(s)(6).
[8] Pub. L. No. 103-417, 108 Stat. 4325 (codified at 21 U.S.C. §§321, et. seq.).
[9]See “Guidance for Industry Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug and Cosmetic Act,” available online athttp://tinyurl.com/lvmse2u.
[10]See http://www.puritan.com/beta-carotene-042.
[11]Seehttp://www.nlm.nih.gov/medlineplus/druginfo/natural/999.html.
[12] A previous Earth and Table blog posts discusses the interplay between FDA regulations and California false advertising laws in more detail. See P. Swanson, “
Fruit Juice Misbranding Claims Lose Their Lanham Act Bite,” posted on June 11, 2012,
[13]Seehttp://summertomato.com/.
[14] R. Pinco and T. Halpern, “Guidelines for the Promotion of Dietary Supplements: Examining Government Regulation Five Years After the Enactment of the Dietary Supplement Health and Education Act of 1994,” 54 Food and Drug Law Journal 567, 577 (1999).