Safety & efficacy – The industry’s mission statement in two small words

29-May-2012 - Last updated on 30-May-2012 at 16:14 GMT

Company mottos and mission statements are marvelous – they talk about lofty goals, commitments to people and the environment, and leaving the planet a better place than how they found it. But boil it all down and there are only two words that companies in the dietary supplements industry should strive to achieve: Safety & efficacy.

Produce products that are safe and efficacious (and only the most zealous out there would claim that every product on the shelves labeled as a dietary supplement is safe and/or works) and this industry will last forever. And the public will be healthier and happier for it.

Silencing the critics

The seed for this comment was planted a few months back during a lunch with a leading industry figure and highly respected contact. “What do you think the industry should be about?” he asked.

That’s easy, I thought: “Safety and efficacy”.

While it may sound simple, it is far from being simple to achieve: It requires hard work and an investment of time, people, and capital.

Industry leaders are sounding the rallying cry on many of the key issues from adulteration to cGMP compliance, and everyone should applaud these efforts. But this is only the beginning - Sleeves need to stay rolled up and the hard work must continue.

I would argue that many companies in the dietary supplements industry abide by this mission statement. But many companies do not: Every week we see FDA sending warning letters for cGMP violations, drug claims on products or websites or social media platforms, Dateline runs a special on dry labbing, allegations emerge that soldier deaths are linked not to hostile fire but to dietary supplement use, the list goes on and on.

If you know your history…

I get the impression that many younger people in this industry take DSHEA for granted, and we do not appreciate how hard people worked to get it passed (and I include myself in that – I was 17 and maturing slowly on a different continent in 1994), but if companies do not fulfill the regulatory requirements that the elder statesmen of the industry fought so hard to achieve, they risk having the rules of the game changed.

Only last week Senator Dick Durbin sought to introduce a last minute amendment to the pending Food and Drug Administration (FDA) User Fee Act to require dietary supplement facility registration and product listing.

The industry grassroots were scrambled, and the Big 5 trade associations mobilized their Capitol Hill champions and the amendment was tabled to a chorus of cheers from the industry.

Remove all doubts about safety and arguments about energy shots and adulteration fall silent.

If a company cannot comply with GMPs with its internal resources and infrastructure, it should ask for external help – there are lots of reputable companies out there that specialize in such services. If the company cannot afford to pay the consultants, and it does not have the resources and infrastructure to comply, then it should not be in this industry. The rules are clear. Don’t go skydiving if you cannot afford the parachute.

Efficacy

As for proving the products work, this may also sound like a no-brainer, but establishing the efficacy of a product with drug-style trials when the margins are not pharma margins makes this a real challenge for everyone. Such trials do need to be done.

The last thing the industry needs is pre-market approval of efficacy. As someone who has spent most of his life in Europe, the last think you want is an EFSA style pre-market health claims process.

Last week we had a beautiful example of quality science when we covered results of a new study from Sweden that were hailed as “results that cannot be ignored” by Cara Welch, PhD, VP of scientific and regulatory affairs for the Natural Products Association (NPA).

Dr Welch’s counterpart at the Council for Responsible Nutrition (CRN), Dr Duffy MacKay, said the study was exactly the kind of evidence that the industry needs to be producing to show how nutrition contributes to health and wellness.

With evidence like this, it would be very difficult to argue against the products, assuming they match the doses and formulations used in the study.

If you think I have stated the obvious then I am happy because it means you are focused on safety and efficacy. I would argue that many get caught up in the fine print of issues like the draft guidance for new dietary ingredients (NDIs) and they lose sight of the bigger picture.

Some companies may also dismiss my pleas in favor of quick profits – burn brightly, make a buck, and the fade away, leaving the rest to clean up the mess. Such players have no place in this industry.

So get those paint cans out, hoist the ladder up the facility wall, and write the following: Safety and efficacy.

Occupy the Industry

Posted by resident regulator, 02 June 2012 - 00:28 GMT

The industry needs to be occupied by those two simple, yet difficult to achieve words. Thank you for addressing "drug-style trials when the margins are not pharma margins." No need for pharma-like trials, to produce quality science. I'm ready with my painted sign, and if a company is angry about that then , like you said, they should not be in the industry. There are plenty in the industry like George Pontiakos for one, who are more than ready to call foul on companies who are out to make a mess.

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Why not efficacy?

Posted by Robert Dadd, 30 May 2012 - 23:15 GMT

There is a big, big difference between the FDA not requiring proof of efficacy for label claims and not providing efficacy period. Lack of clinical trials does not equal lack of efficacy for starters. Secondly, consumers certainly want efficacy so the industry had better be providing it if they want any measure of success and long term sustainability.

Not efficacy....

Posted by Steve Baugh, 30 May 2012 - 19:36 GMT

Efficacy is not a word in our industry. My opinion is all the regs hang on Identity, purity (strength)and safety. Efficacy is not a requirement, and the FDA just got spanked for requiring clinical trials for label claims. Efficacy is 21 CFR Part 211, not 111....