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Supplement Label Blues: Don’t Blame the Brands, Blame the FDA, FTC

August 25th, 2008

Despite a popular perception to the contrary, the vast majority of supplement companies really do have your best interests at heart. After all, the best – and only – way for them to secure long-term profitability is to make effective and safe products; failing to do either one of those guarantees a fast-track to the clearance rack with all the other duds. Although, as in any industry, there have been and will be those few companies out to make a fast buck, most companies are looking at long-term growth and profits and the only way to secure those is to make safe and effective products.

But as good as the product inside the bottle may be, it can be very hard for consumers to sort the winners from the losers just based on label information. Why? Well, it’s only rarely due to manufacturers deliberately trying to be vague or deceptive. The truth is, there are so many restrictions on labels and label information that brands have had to resort to using and re-using the same few catchphrases and jargon to avoid trouble with the FDA or FTC. That keeps them on safe ground legally, but only at the expense of communicating with their customer in a clear and straightforward way.

We feel the the root of the problem is that the science, research and development of nutritional supplements have evolved so rapidly and broadly that they’ve essentially outgrown the legal framework intended to regulate how they are advertised and marketed.

The FDA, and to a lesser extent the FTC, have traditionally regulated and enforced the laws that pertain to ‘dietary supplements’. There was a time not too long ago when the only supplements available were essential nutrients like vitamins and minerals which could be and were obtained from the diet, even if in insufficient amounts. As such, it made sense for the FDA – the Food and Drug Administration – to regulate them.

In 2008, it’s a much wider playing field. Although the essential-nutrient supplements still represent a huge chunk of the market (fish oil, vitamin C), thousands of other popular supplements have become popular that really have nothing to do with meeting the daily requirement for this or that nutrient. Instead, they are intended for specific purposes, including medical/therapeutic purposes (lowering cholesterol, treating constipation) and non-therapeutic lifestyle-enhancement purposes (preworkout formulas, brain boosters, detox, etc). These products are neither foods nor drugs, which calls into question whether or not consumers would be best served having this industry continue to be regulated by the FDA, or whether a new or different agency would be better.

But until things change, the significant and often awkward restrictions the FDA and FTC have placed on what supplement makers can say and how they say it will continue to make life difficult for both supplement makers and the consumers. And although supplement companies have learned to live with and work around these restrictions, it’s becoming increasingly hard for manufacturers to both describe the benefits of a product in an accurate and straightforward way and stay within the legal boundaries established by the FDA and FTC.

A review of its website and warning letters suggests that the FDA seems most, but not solely, concerned with what they consider to be ‘drug claims’ made by supplement companies on behalf of their products. A ‘drug claim’ is the explicit or implicit suggestion that a supplement can be used to diagnose, treat or prevent a disease or medical condition. Only after a compound has been through the FDA’s notoriously expensive and lengthy drug-approval process (10 years, tens of millions of dollars) can a drug claim be made.

That doesn’t seem unreasonable at face value, since drugs can be presumed toxic by nature and therefore should be held to the highest standard of safety. But one unfortunate consequence of this stipulation is that it guarantees that only the largest and wealthiest pharmaceutical/nutraceutical firms – not necessarily the best or most innovative – can produce new drugs. And also that only the most profitable drugs for the most common conditions ever have a good chance at seeing the light of day.

We feel that nutrients found in foods and herbs – many of which have been consumed and used safely for centuries – should enjoy a basic presumption of safety and therefore be held to a different, not necessarily lower, standard of safety testing and therapeutic applications. What those standards are or should be is another discussion entirely. But when there are clear health benefits and minimal risks to using a supplement for therapeutic purposes, brands should be given more latitude to describe these benefits in clear accurate language without fear of legal action. A toxic, side-effect-laden drug – once it’s approved – can be advertised as lowering cholesterol, even though it may or may not lower cholesterol in a given individual. That’s no different than a fish oil or Sytrinol supplement; they may or may not lower cholesterol, but although they are both safer and cheaper than cholesterol drugs, a label can’t make any such claim even if well-designed clinical tests have been supportive of that claim. What matters is whether or not the item has gone through the FDA’s drug-approval process or had that claim evaluated by the FDA, both of which are enormously expensive cost-prohibitive undertakings. The most it could legally say is something along the lines of the tepid, distanced “May support cholesterol levels in the normal range” type of claim.

With few exceptions, only drugs can make clear straightforward claims about their benefits with respect to specific conditions. The safety and usefulness of dietary supplements for specific problems has been documented to the satisfaction of any reasonable person, yet supplements are dogged by regulations that, at the end of the day, seem to protect mainly drug company profits at the expense of public health.

Another major labeling problem that needs to be sorted out at the government/institutional level concerns Intellectual Property. The supplement industry does not enjoy the same kinds of intellectual property protections as other industries. They can trademark a name, but product protections like patents are essentially nonexistent in this industry, with the exception of the so-expensive-it’s-rarely-worth-it nutritional use patent. The current inability for makers to patent and truly protect their product or formulas forces brands to chose between protecting their formula from competitors and meaningfully informing their customers. Thus they have to resort to describing their formulas as vague ‘Proprietary Blends’. A Proprietary Blend must list all ingredients, in order of concentration from most-to-least, but individual amounts are not specified. This really hurts the consumer more than it protects the brand from a competitor copying a formula. After all, the competitior could always have a product analyzed to determine exact amounts, and then just change one or two ingredients slightly. The consumer won’t have the resources to do that. Nor will the consumer be able to make an informed decision about that Proprietary Blend without knowing the potencies of individual ingredients. So, just as holding supplements to drug-approval standards does, the Proprietary Blend approach ultimately fails to protect either the consumer’s or the manufacturers’ interest.

The best solution may be a fresh look at the government institutions and laws the regulate the supplement industry , and recognizing that the industry’s explosive growth and innovation demand an entirely new framework of regulation, one that protects consumers’ and manufacturers’ interests equally well.

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