Later on this spring, the Food and Drug Administration will convene a meeting that will start a dialogue on what an amendment to the Dietary Supplement Health and Education Act might look like. DSHEA created the dietary supplement category almost 25 years ago, and consensus has been building that the law could use an update.
Market has changed significantly in 25 years
One of the reasons for looking at modifications to DSHEA is that the marketplace has changed dramatically in the intervening generation. The advent of the Internet has revolutionized the way supplements are sold and has had a huge effect on how manufacturers and suppliers communicate to consumers about the benefits of their products.
Another revolution that has occurred in the meantime is the advance of technology by which ingredients that were first discovered as constituents of plants can be produced without the aid of photosynthesis.
Producing ingredients that can be found in plants without actually extracting them from those sources is nothing new, really. For decades now most vitamins have been produced in tanks via various fermentation processes. ‘Traditional’ fermentation (to distinguish it from the synbio variant, of which more later) is a food production technology almost as old as agriculture itself, and arose probably the first time someone left a jar of damp grain or a skinful of camel’s milk too long in the sun.
It would probably come as some surprise to consumers to find that most if not all of the added vitamins in the products they consume didn’t originate in a fruit or a vegetable. But this has been true for a long time now, and consumers don’t seem to be clamoring for this information. Nor have large numbers of them shown a willingness to pay more for ‘whole food’ vitamins, even though some companies, notably MegaFood, have made this a viable business strategy.
As we move up the scale of artifice, we come to chemical synthesis. In this mode, feedstocks are assembled and subjected to a reaction or more likely a series of reactions to arrive at the desired molecule. Food ingredients and additives have been produced this way for decades and some of them, such as synthetic versions of resveratrol and astaxanthin, have found their way into the realm of dietary ingredients.
Food additives produced in this way have to go through batteries of toxicity tests to prove their safety. So even though these ingredients are not ‘natural’ per se, a long history of use as well as the initial testing has shown that they’re safe.
Production via synthetic biology
The most recent entrant along this line is so-called ‘synthetic biology.’ In this mode, innovators have built upon traditional fermentation. Rather than combing through the thousands of species of microbes to find one that will secrete the molecule you want, which could amount to a fool’s errand, the approach has been to tweak the genetic makeup of a given microbe to alter how it digests a certain feed stock. It’s a biological process, sure, but conducted by an organism that didn’t exist until it was created in a lab.
In both these cases, consumers might be confounded to discover just how the ingredients in the supplements they use are made. The supplement industry grew out of products with an obvious provenance, like cod liver oil in the omega-3s space, or herbal teas and tinctures in the botanical realm. And many are still sold in health food stores, or what is otherwise referred to in the business as the ‘natural channel.’
Do supplements need to be ‘natural?’
Dietary supplements have always had a position as the red-headed stepchild of the natural products business. They are packaged in bottles that in many cases seek to emulate pharmaceutical packaging. Some of them allude to their natural origins, while others, such as some of the pre workout and other sports products, seem to revel in their synthetic nature.
So how do ingredients manufactured in these ways fit in? It’s one of the questions that will have to be hashed out in the DSHEA 2.0 discussions, which will most likely include a negotiation about the NDI draft guidance. At the moment, FDA is of the opinion that a synthetic copy of a botanical ingredient is not a legal dietary ingredient, because it doesn’t meet the definition laid down in DSHEA. Even though it looks and quacks like a duck, it’s not a duck, in other words. I think it’s unlikely this line of thinking will stand, given the significant pushback this has engendered from the industry. It might require new statutory language, but I can’t see the industry abandoning this avenue of manufacturing innovation.
Being transparent about the provenance of ingredients
So these kinds of ingredients are here to stay. Assuming that the regulatory requirements have been met in terms of GRAS affirmations or NDI Notifications (sadly, not always the case today) I don’t see any reason why they can’t continue to hold a place along any of the more ‘natural’ ingredients.
But by the same token, given the tide of increasing transparency in the industry, I don’t think they should get away with coyly waving the natural flag, either. There was a synthesized ingredient on the market that was originally discovered in a species of berry. At one time the supplier of this ingredient (since removed from the market) was advertising it with cascades of the fruit on its signage, which always seemed disingenuous to me.
If you are using a synthetic ingredient, I think that should appear on the label. This has been done for years in foods. Let the consumers decide. If they like your value proposition, you can still prosper, without clinging to the coattails of other, likely more expensive ingredients that are closer to their natural forms.