FDA Rules for vitamin claims

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Nutrient Marketing and Commercial Free Speech
The Standard of Substantiation

Note from Tim Bolen - Ralph Fucetola has been a good friend, and resource, for several years. For those of you who maintain a website offering products or services, I recommend you pay CLOSE attention to what he says... He'll keep you safe.

Sunday, December 12th, 2004

Guest Editorial by Ralph Fucetola, JD
http://www.vitaminlawyer.com/ ralph.fucetola@usa.net

Introduction to Dietary Regulations

Not since the heady days just after the Dietary Supplement Health and Education Act (DSHEA) was adopted in '94 and the nutrient market became wide-open, has it been possible to sustain supplement claims to a reasonable degree of certainty. Businesses need to know what they can claim and how they can substantiate those claims. In the "bad old days" before DSHEA, claims were not an issue? since none were allowed! In recent years, though, it seemed that the opening for honest speech about nutrients created by DSHEA was floundering on state, national and even (via Codex) international regulations, restrictions and prohibitions. The banning of tryptophan and ephedra come to mind, as does the highly restrictive European Union Food Supplement Directive.

However, a couple recent US court decisions and even FDA/FTC regulatory actions point in a good direction and suggest a broader scope for claims. Led by a slim Supreme Court majority, the Right of the Public to Information is being given increasing protection.

DSHEA Requirements & Recent Court Actions

Basically, DSHEA allows (1) general wellness claims, (2) structure and function claims (with post-market notice to the FDA) and (3) health claims (with pre-market FDA approval). Also, new dietary substances have a pre-market FDA petition requirement.

Just one of these areas, Structure and Function claims, is the subject of FDA rule making with over ninety pages of official explanations ? which is why marketers need the advise of savvy lawyers before they speak about their products!

The first case to have broadened the FDA's horizons was the case won by research scientists Durk Pearson and Sandy Shaw in the DC District Court, Pearson v Shalala, in 2000. This case mandated the FDA to consider disclaimers and explanatory language before summarily disallowing claims, and specifically health claims (health claims are claims that characterize the relationship between a nutrient and a disease, while structure and function claims are those that characterize the relationship between a nutrient and normal structure and function).

As I learned in the Diabetiks matter, the FDA is actually responding to the court mandate. In that matter, The Green Turtle Bay Vitamin Company, Inc. - www.energywave.com - offered a disclaimer when the FDA wanted a change in the product name (it makes an ?implied health claim? by using the name of a disease). The disclaimer, which was rather more of a claim -- and a powerful one at that -- was accepted and the name remains unchanged, but now, the company can say that the FDA has permitted the claim ? instead of just having to rely upon the DSHEA mandated "FDA has not evaluated these statements" disclaimer.

Further, during the joint FDA/FTC "Operation Cure-All" in 2001, several Internet purveyors of targeted products avoided citation, recall and fine, by stripping all claims from their sites and "running naked" on word of mouth alone.

Thompson v Western States Decision

More recently, the United States Supreme Court (Thompson v. Western States Medical Center, 01-344, decided on April 29, 2002) has offered significant support to Commercial Free Speech.

This decision has not received the attention of the marketplace that it deserves. The 5 to 4 majority decision revealed a Court deeply divided on the issue of Commercial Free Speech. One large minority of four justices, led by the Chief Justice, would give the government far greater leeway to regulate Commercial Speech than the majority decision allows. The other large minority of four, led by Justice O'Connor, repeated the Two Prong Test of prior regulation cases, applying it to FDA statutory requirements. The swing vote, Justice Thomas, is most telling. In his Concurring Opinion, the Justice refers to "Commercial Speech" only in quotes, indicating that he takes the position that there is no "Commercial" Speech, just Speech, protected by the First Amendment. This is the position favored by the Health Freedom and Freedom of Choice movements.

This case concerns a clause in the Food, Drug and Cosmetics Act that allows ?compounding? pharmacists to "compound" medications for specific customers without safety testing and FDA prior approval, but forbids pharmacists from advertising the specific compounds they make. The Supreme Court held that the restriction on Commercial Speech was unconstitutional, using language that will help broaden not just the rights of pharmacists, but also the rights of all people in the health and wellness field, including those who sell nutrients. We might dub it the Public?s Right to Truth Decision. Some of the language used in Justice O'Connor's Majority Decision that sets the tone is as follows:

"If the First Amendment means anything, it means that regulating speech must be a last - not first - resort."

"We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information."

"Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each compounded drug to be labeled with a warning that the drug had not undergone FDA testing and that its risks were unknown."

The basic rule, announced by the case, to determine constitutionally permitted government restrictions on Commercial Speech (speech that makes or is about an offer for a transaction) is a Two Prong Test: the first prong is to ask two questions: (1) is the speech in question about unlawful activity and (2) is the speech misleading. If "no" to both, the speech is entitled to protection unless the Government can carry its burden and prove (1) the governmental interest involved is "substantial", (2) the regulation must "directly advance" the governmental interest and (3) the regulation of Commercial Speech cannot be "more extensive than is necessary to serve that interest" (quoting Central Hudson v Public Service, 447 US 557, at 566).

Substantiation and the FTC

FDA says it follows the FTC?s view in determining the level of substantiation needed for claims. In this context is it useful to recall the 1996 comments of FTC Commissioner Starek, at the National Infomercial Marketing Association (comments the FTC still maintains on its web site). He explained the issue to which the Court alluded -- preventing misleading advertisements.

"As many of you know, the FTC is charged with protecting consumers from unfair or deceptive acts or practices. In advertising and marketing, the law requires that objective claims be truthful and substantiated. The FTC does not pursue subjective claims or puffery -- claims like "this is the best hairspray in the world." But if there is an objective component to the claim -- such as "more consumers prefer our hairspray to any other" or "our hairspray lasts longer than the most popular brands" -- then you need to be sure that the claim is not deceptive and that you have adequate substantiation before you make the claim. These requirements apply both to explicit or express claims and to implied claims. Also, a statement that is literally true can have a deceptive implication when considered in the context of the whole advertisement, even if that implication is not the only possible interpretation."

"The substantiation requirement exists because every time an advertiser makes an objective claim, the advertiser also implies that there is a reasonable basis for the claim. This reasonable basis is substantiation. What constitutes a reasonable basis for a particular claim can vary, depending upon the nature of the claim, the product, the consequences of a false claim, the benefits of a truthful claim, the cost of developing substantiation for the claim, and the amount of substantiation that experts in the field believe is reasonable. Health and safety claims generally require competent and reliable scientific evidence. And if a marketer makes a representation that a claim has a particular level of support -- for example, "clinical studies prove..." ? the law requires at least that level of substantiation."

Thus, Commercial Speech, if properly substantiated, is protected by Constitution and Law. As Justice O'Connor intimates, properly worded disclaimers and warnings are the preferred method for ensuring that Commercial Speech is truthful and protected. The Supreme Court decision in Thompson supports the lower court decision in Pearson.

The Standard for Substantiation

What is the proper level of substantiation for Nutrient Claims? It is not the "significant scientific agreement" required of drug claims, but rather, the general "competent scientific evidence" standard that applies to all commercial claims.

That does not necessarily mean that Dietary Supplement purveyors need to have multiple double-blind experiments (as may be required for drug approval). Such substantiation just needs to be competent and scientific. This means research studies (which is when scientists review the work of others and apply it to specific questions) and clinical trials (which can be as formal as double-blind, placebo controlled investigations) as well as traditional knowledge and clinical experience all have a role to play, but ultimately, such substantiation must rest on the informed professional opinion of some credentialed person who can sign onto the Structure and Function Claims Notice to the FDA, attesting that "the notifying firm has substantiation that the Statement(s) to which this Notice applies is truthful and not misleading." (Regulations under 21 U.S.C. 403(r) (6)). Thus, the Regulation requires only ?substantiation? without specifying a specific level of substantiation.

See also the Small Entity Compliance Guidance on Structure & Function Claims -
http://www.fda.gov/OHRMS/DOCKETS/98fr/98n-0044_gdl0001.pdf.

The Code of Medical Ethics of the American Medical Association has begun to acknowledge the role of nutrition and other alternatives in healing and thereby given us further thoughts on the issue of substantiation. The original Hippocratic Oath, with its injunction to "Do no harm." has been replaced by a complex Code detailing the relationship between physician and patient and alternative practitioner. Recent changes reinforce the distinction between the level of proof needed to claim a medical ?cure? and the level of substantiation required for nutrient claims.

While "treatment which has no scientific basis" remains condemned (Opinion 3.01), under Opinion 3.04, physicians are free to refer a patient "for therapeutic or diagnostic services to another physician, limited practitioner or any other provider of health care services permitted by law to furnish such services, whenever he or she believes that this may benefit the patient." Thus, unscientific "treatment" is distinguished from "health care services permitted by law" and "treatment" -- which means the use of standard medicine and surgery to "cure" disease -- is distinguished from other health care services which need only meet the lesser "may benefit" standard. Thus, nutritional approaches can be seen to complement licensed medicine, but not to be held to its strictures, nor limited in its practice to licensed physicians. Nutrient marketers need not ?prove? their claims (with ?significant scientific agreement") but need only show ?benefit? with competent scientific evidence.

Conclusion

Properly advised by knowledgeable counsel, nutrient purveyors need to continually review the claims they are making to ensure that the claims are both permitted by law and the strongest the law will allow, to the end that the Right of the Public to Truthful Wellness Information may be preserved.

This is a necessary step in preserving the even more central Right of Individuals to Freedom of Choice in Health Care. Never doubt that, in this great clash between the Right of the Public to Know and the power of the government to restrict, the free flow of information can no longer be regulated by government agencies so as to deny a Free People access to Truth.

Ralph Fucetola, JD
http://www.vitaminlawyer.com
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