Natural Products Industry Dot Edu

By James J. Gormley

These days there is much discussion — as there should be — about standards, certifications, and what’s in a given bottle of supplements (such as superior quality ingredients) and what’s not in it (e.g., GMO-free and gluten-free).

But what can empower a company to confidently map out the life trajectory of a dietary supplement from sprout to shelf? Education.

It is fortunate, then, for producers and consumers that the Natural Products Association (NPA) and UL (Underwriters Laboratories), a “global independent safety science company with more than a century of expertise innovating safety solutions” are now working together to offer “increased educational opportunities to NPA members,” according to a recent NPA announcement.

Having served on the NPA Education Committee some years ago, and having helped companies comply with regulatory requirements since then, I can confidently say that this educational boost will help participating member companies learn, brush up on, and master what is needed to navigate the oftentimes confusing seas of regulatory compliance.

From preparing for cGMP inspections, to cGMP quality control requirements, to production and process controls, to structure-function claims and labeling, to SOPs and more, the planned educational modules appear to address a whole range of critical areas important to the natural products industry.

The new partnership will combine NPA’s regulatory and compliance expertise with “top-notch training modules from EduNeering, the online regulatory training division of UL,” according to the NPA.

“Given the combined reputation and expertise of both NPA and UL, our collaborative efforts to bring elevated education to the natural products industry is the logical next step for both organizations,” said Daniel Fabricant, Ph.D., CEO of the NPA.

“NPA brings a level of regulatory expertise in Dr. Fabricant and Dr. Corey Hilmas that is unmatched in the dietary supplement industry, and UL is very pleased to be partnering with them in this new endeavor. Through this alliance, the industry and consumers will undoubtedly be better served,” said Mike O’Hara, general manager of global nutraceuticals for UL.

“Our combined vision is to see one program the industry can turn to for dietary supplement education, and we see this being that program,” Dr. Fabricant added. “We anticipate this to be the start of a lasting relationship between NPA and UL that will reflect this shared vision and impact our industry in a very profound and meaningful way.”

Given UL’s global recognition and universal adoption, I anticipate good things coming out of this collaboration, including a more savvy industry marketplace that is better equipped and stronger than ever before, which will benefit the industry and consumers.

[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

Health Freedom and Politics: Taking Arms Against Seas of Trouble

Whether 'tis Nobler in the mind to suffer

The Slings and Arrows of outrageous Fortune,

Or to take Arms against a Sea of troubles,

And by opposing end them […]

----Hamlet’s soliloquy

By James J. Gormley

Politics. Health. Freedom. One would like to think that freedom is intertwined with both, but often freedom is at odds with the politics of control and held at arm’s length from anything approximating true health.

Why is this? Well, one definition of “politics” is: “the debate or conflict among individuals or parties having or hoping to achieve power.”

This power can be the ability to impose nanny-state, Big Government restrictions on access to natural health products and treatments and information about them.

The power can also stem from the lobbying largesse of Big Pharma and Big Agra, economic potentates that dictate what synthetic, genetically modified, or otherwise perverted foods, plants or chemicals (or systems governing them) get their way and why natural ingredients, botanicals, or dietary supplements do not.

But politics is not inherently bad; in fact, in ancient Greece being a politician was the greatest calling to which a person could aspire. Debate and conflict are not in essence bad, either; they are merely, at best, the means by which people or nations confront problems and protect interests.

Power, like a sword, can cut both both ways, depending on who is wielding it and to what end; it is, in essence, the currency or capital that can, at best, fuel change.

So as an executive and/or decision-maker in the natural product industry, how do you navigate the political minefield that surrounds us? How do you “take Arms against a Sea of troubles, And by opposing end them […]”?

As a natural products industry, we have taken arms against many seas of trouble in the past and, in most cases at least, we have risen victorious: the Hosmer-Proxmire Vitamin Bill in the 1960s and 1970s, USDA Organic and DSHEA in the 1990s, and the recent NDI Draft Guidance (so far at least).

To better navigate these seas, here are some common questions to which I will provide answers (or at least short, pithy, and potentially obnoxious suggestions):

• What are the best ways to stay on top of the industry’s political issues? First, turn to your contacts at the Natural Products Association (NPA), the American Herbal Products Association (AHPA), and the Council for Responsible Nutrition (CRN) to find out what are the latest issues and campaigns. Then, to get your consumer’s perspective, turn to Citizens for Health (CFH), the Alliance for Natural Health (ANH-USA) and the National Health Federation (NHF), because industry issues don’t always align with consumer interests, although they should.

• What is limiting your political clout: sketchy partners, bad business practices, etc.? You want to stand out from the crowd, but in a good way. Steer clear of companies trying gimmicks (such as religious exemptions, etc.) to avoid FDA scrutiny and also those companies that think USP standards and GMPs are football abbreviations.

• When should you decide to support a politician? And, if you do, how do you go about doing that? While an individual may give a maximum of $2,600 to an individual politician, PACs (Political Action Committees) can received donations of $5,000 for candidate committees and Super-PACs have no limits. Before donating any money, check out the lawmaker’s entire voting record.

• When should you back down from an issue? Better than backing down, gauge consumer sentiment before backing an issue, so you never have to back down.

• When should you get involved in foreign politics? I don’t think we should ever get involved in foreign politics, however we should not hesitate to get involved in international food trade and safety negotiations. Industry representatives include IADSA and CRN and consumer representatives include the National Health Federation.

[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

What’s old is new again? The FDA takes aim at modern science and innovation

By James J. Gormley

On January 4th, 2011, the Food Safety Modernization Act (FSMA) was signed into law. It included a number of requirements, including one that the FDA issue industry guidance as to when companies need to submit New Dietary Ingredient (NDI) notifications to the agency and when they do not, and about 186 calendar days after that, on July 1st, the FDA issued a draft guidance on new dietary ingredients.

What is all this about old and new dietary ingredients? Old dietary ingredients (ODIs) are nutritional ingredients ─ herbal extracts and nutrients ─ that were sold prior to 1994 and were considered to be “grandfathered in,” and “generally recognized as safe” when NDI submissions were first required, so manufacturers did not need to worry about ingredients that were always in the food supply in foods or food-based supplements.

NDIs, on the other hand, were supposed to be completely new compounds – often hybrids of nutrients – never before seen in nature in exactly that form. Notwithstanding, this itself was always considered a strange requirement, however, since many safe nutrients are often combined with other safe, natural substances that help the mineral or vitamin’s absorption, so how could these benign compounds be considered “new” when compared to products of genetically engineered bacterial fermentation, for example.

So, many companies were advised by legal and industry experts to not submit NDI notifications since the products in question were exempt from the requirements since the individual parts of the compound were considered safe anyway. On top of that, the FDA was rejecting so many NDI submissions on administrative grounds alone that companies understandably began to see the NDI process and non-objection threshold as impenetrable, indeed.

Fast forward to this guidance, which was actually originally mandated in our main dietary supplement law, the Dietary Supplement Health and Education Act of 1994 (or DSHEA), but it has somehow taken the FDA 17 years to get around to it.

The FDA and its apologists are saying that this is no big surprise and has been a long time in the making. Be that as it may, natural products industry organizations have raised a number of important objections to the dangers to innovation posed by this guidance and policy and procedures that may well follow from it.

“We believe the draft guidance does not match Congress’ clear intent that products made from ingredients on the market prior to DSHEA should remain on the market,” noted the Natural Products Association in a July 6th statement.

As the “decision tree” provided by the FDA with this guidance makes clear, if a new manufacturing process, extraction method or plant part is used, then it is a new dietary ingredient!

This is absurd! This means that if hexane or other harsh solvents were used in the past, and safer solvents are used today that better preserve the integrity of the ingredients (such as grain alcohol or glycerin), that these solvents now render the ingredients as NDIs even though the extracts are closer to what’s growing in the soil than how it was extracted in 1993!

As Steve Mister of the Council for Responsible Nutrition (CRN) said to Nutraingredients-usa.com, “They are trying to freeze industry in 1994 and lock us into extraction processed used 20 years ago.”


The guidance also states that synthetic versions of natural ingredients are also NDIs. What!? Virtually every product sold today includes synthesized, exactly bio-identical versions of what is found in a plant, nut, seed, fruit or soil. We are not talking artificial ingredients here; think vitamin C, as that’s what we’re talking about. If this is followed by FDA, most supplement ingredients and supplements containing them could eventually get their manufacturers slammed with notices of failure to submit a 75-day pre-market NDI notification, likely since most companies have been selling these ingredients and products for 17 years!

Attorney Marc Ullman, of Ullman, Shapiro & Ullman, told Nutraingredients-usa.com that this position on so-called synthetic nutrients is “preposterous, absolute nonsense” and with “no basis in science.”

In addition, the safety testing requirements recommended for NDIs go way beyond anything that could be reasonably required for herbal ingredients and nutrients. These over-the-top standards would be similar to what is required of food additives. It would not provide more safety; it would merely force companies to spend millions on unnecessary tests on ingredients that have been in the food supply for 10,000 years.

According to Ullman in Natural Products Insider, the guidance shows that FDA is taking an “incredibly narrow view of what can be considered a dietary ingredient and an incredibly overbroad view of what would require the submission of an NDI notification.”

What do consumers and retailers need to be aware of regarding this guidance? It is not law, not regulation and not binding . . . however, and this is a biggie . . . it gives a very clear picture of the intent of the FDA to use these side-door and back-door routes to undermine and effectively dismantle DSHEA, the law that protects our right to safe and effective dietary supplements.

If FDA were allowed to interpret the law in this way, it would endanger thousands of products and scores of categories of supplements, extracts and tinctures. The ones that survived would be locked into pre-1994-era processing and manufacturing standards, and innovation would be almost totally blocked, since any new advances used with existing ingredients would require participation in the draconian NDI notification process.

Gormley Take-Away: What do we all need to do? We need to file a comment with the FDA telling them to withdraw this notification as it is an outrageous, and unacceptable, approach to re-classifying hundreds, if not thousands, of safe dietary supplement ingredients. If you agree, let the FDA know that you will not stand for this egregious attempt to roll back the clock on innovation by nearly 20 years, to grievously harm the health food industry and to set the stage for far less choice and for virtually no more cutting edge products going forward.