Is the clock ticking on Natural Supplements?

This article aims not to spread fear but to inform you about a potential crippling blow to the natural health and supplement industry.

Over the past few months, we have learned the natural health industry is under attack. 

We are continuing to monitor that the FDA could be preparing to unleash an anti-supplement act targeted towards the natural health industry as early as next year (2022). This new policy has the potential to eliminate tens of thousands of natural products from the market—in the middle of a pandemic.

Recently, the FDA announced by the end of June 2022, it plans to draft a number of policies, among them the “New Dietary Ingredient” (NDI) guidance (“new supplement” guidance, in plain English). It is no exaggeration to say that this is the most dangerous threat to natural supplements we’ve seen in decades.

Background

Under DSHEA, supplements released after 1994 must notify the FDA 75 days before sale. The proposed policy changes this into a near pre-approval process, mirroring that of drugs.

The FDA’s policy

For the natural health industry is nothing less than a massive directive aimed at crippling the supplement industry. 

 Next year we may see:

• tens of thousands of natural products disappearing from store shelves
• an industry-wide cost of between $2 billion and $165 billion in animal and human safety studies to comply with the FDA’s NDI notification protocols
• the loss of between 50-100,000 jobs in the supplement industry

How will the FDA’s new guidance do this? First, it imposes safety requirements on new supplements beyond even what drugs are expected to meet!

The FDA requires specific safety studies for NDI notifications, with changes in target groups possibly needing more research.

If adults safely use a substance but it's for children's supplements, the FDA needs a new NDI notification.

Drugs often fall short of this standard, with the FDA noting that many are not tested in children.

Safety studies for supplements may sound reasonable but remember

Requiring these studies is part of the FDA approval process for drugs. Drugs can afford them because they are patentable.

Mandating pre-market studies for non-patentable, natural supplements poses cost recovery challenges unlike for pharmaceuticals.

 This will either force companies to go out of business - or it will make supplements so expensive that they are priced out of the market. 

The FDA is widening its scope on supplements, requiring new notifications for those considered 'chemically altered' under an expanded definition.

A post-DSHEA ingredient present in the food supply without chemical alteration is exempt from submitting an NDI notification.

The Problem Lies In How the FDA Defines "Chemically Altered."

Is so broad that only the most basic manufacturing methods would not “chemically alter” an ingredient.

This language will stifle innovations in manufacturing and ignores the fact that new and more effective ways of producing supplements have arisen in the last 22 years since DSHEA was passed.

The FDA's upcoming guidance in June 2022 might restrict natural health solutions amid the pandemic.

We aim to enlighten, not frighten, on industry effects.  The natural health industry is potentially looking to surmount in the near future.