Now that the U.S. Supreme Court has ruled that the Freedom of Speech Amendment in the Constitution truly means “freedom of speech,” the aftershock of this ruling is yet to be realized as it reaches far into America, including dietary supplement labels.
Dietary supplement marketers have long been frustrated over the FDA’s narrow rulings regarding health and disease claims on product labels, particularly for obvious dietary deficiency disorders. For example, the label on a bottle of vitamin C pills cannot say their products allay the many prevalent symptoms of scurvy (vitamin C deficiency) even though they have been well documented for decades.
Currently the FDA regulations mandate each brand of vitamin C must undergo human clinical trials to prove they address the many symptoms of scurvy such as skin bruising, bleeding gums, weak capillaries, irritability, shortness of breath, joint pain, poor wound healing, inflammation of the tongue, curly brittle hair, loose teeth, loss of appetite, pinpoint red skin hemorrhages (petechiae), fatigue, eye hemorrhage (conjunctiva), etc. Then, even if such studies are conducted, that vitamin C pill will be absurdly designated as a drug!
The newly issued ruling (Reed vs. Town of Gilbert) emanates from discrimination by officials in Gilbert, Arizona against a church led by Pastor Clyde Reed that placed small signs in public places inviting others to attend events at their location. Gilbert city officials said their ruling attempted to reduce clutter but contrarily allowed unrestricted posting of political signs for re-election of city officials. Most cities are also cluttered with real estate signs, yard sale signs, even signs saying the local high school is conducting a fund raising car wash. The unanimous ruling was that government can’t discriminate and must take an even-handed neutral position regarding public signage. [Jurist Aug 4, 2015]
Another lower court ruling
Now let’s take the 1st Amendment regarding freedom of speech and jump from road signs to food and drug labels, dietary supplements included. Another recent lower court ruling may also liberalize dietary supplement labeling.
Even though about 1 in 5 drugs prescribed by doctors are for unapproved conditions, while doctors have a right to prescribe what they believe is best for a particular malady the makers of these drugs must submit a new drug application for each and every new use of a drug regardless of whether there is some scientific evidence already in existence that the drug works for as yet unapproved conditions. In other words, doctors may prescribe but drug companies may not advertise off-label uses of their remedies.
However, this FDA dictate may be subject to change if a recent court ruling sticks. The Second Circuit Court has ruled that “truthful promotion” of off-label uses is Constitutional-protected speech beyond the regulatory reach of the FDA. Because pharmaceutical companies are forbidden to even distribute copies of published studies involving off-label uses of their products, the Circuit Court is saying such a ban interferes with the ability of physicians to make intelligent decisions. [Wall Street Journal Aug 14, 2015]
This lower court ruling also has application to dietary supplements. Why shouldn’t makers of vitamin pills have the right to distribute copies of scientific studies showing the ingredients in their products address obvious vitamin deficiency diseases, such as vitamin C prevents scurvy, vitamin D prevents rickets, vitamin B1 thiamin prevents beri beri, vitamin B2 niacin prevent pellagra, vitamin B12 prevents pernicious anemia?
The two-month old Supreme Court ruling has already been used to require lower courts to strike down laws barring automated phone calls and panhandling. So applications of this new ruling are rapidly being implemented.
What has resulted is a First Amendment review of forms of free speech called “strict scrutiny.” This requires government to prove that the challenged law is “narrowly tailored to serve compelling state interests.” This means that only the rarest of statutes would survive legal examination. As one judge said: “Any law distinguishing one kind of speech from another by reference to its meaning now requires a compelling justification.” [New York Times Aug 17, 2015]
A ruling on dietary supplement claims has yet to reach a court of law. To date, only a lone attorney in Washington DC has singlehandedly taken on the FDA on this issue. [Emord.com] Fearing retaliation, there hasn’t been a single dietary supplement maker willing to challenge the all-powerful FDA regarding 1st Amendment rights over dietary deficiency health claims.
Accuracy in labeling (dose and form of nutrient)
These new court rulings don’t completely allow dietary supplement manufacturers to get away with false advertising. Does vitamin C cure symptoms of scurvy at any dose? Making a label claim that a branded vitamin C pill cures scurvy when it only provides 5 milligrams of vitamin C would not be completely truthful.
The form of a vitamin may also be important. For example, thiamin (vitamin B1) remedies symptoms caused by alcohol consumption but may only do so when provided in a fat-soluble form (benfotiamine) since alcohol blocks the absorption of thiamin. [Drug Alcohol Dependence Dec 1, 2013; European Journal Pharmaceutical Science March 12, 2013]
Another example is supplemental zinc for the common cold. Only ionic zinc lozenges (zinc gluconate) that provide 18 milligrams of zinc are likely to reduce the duration of a cold. [Medical Hypotheses March 2010]
Supplemental vitamin D cures rickets (bone softening). However, synthetic vitamin D2 (ergocalciferol) is not equivalent to natural vitamin D3 (cholecalciferol). [European Journal Clinical Nutrition June 2015; Nephron 2015; British Journal Nutrition March 28, 2013]
Now all we need is for some brave dietary supplement maker to step up to the plate and challenge the FDA on its restrictive labeling policies and make a label claim that an essential vitamin or mineral supplement remedies a dietary deficiency disease.