fda compliance

Today I wanted to talk about compliance… it is a delicate topic, and sometimes frustrating or misunderstood. I want to clear some of the air surrounding this controversy and perhaps shed a little light on benefits of following the rules.

What is the FDA and what do they do?

The U.S. Food & Drug Administration was established in 1906, and for good reason. Following an era of industrialization of modern medicine and lewd marketing tactics by sales men pretending to be herbalists or doctors, the FDA was a much needed monitor to keep the public safe and keep not-so-well-meaning business people in line.

The terms ‘snake oil’, or ‘snake oil salesman’ are direct references to 19th traveling medicine shows. Men who promoted a sketchy product (often mostly opioids, and/or flavored alcohol), and promised it would ‘cure what ails ya’.

With the introduction of the FDA, Charlatans selling snake oil, could no longer continue promoting certain product claims without the FDA officially testing the quality and effectiveness of said product and approving it (or not). Businesses must now be ‘compliant’ do the FDA requirements of what is allowed or not allowed to be ‘claimed’ about their products.

FDA Compliance – What it means for herbalists and oilers

compliance list
[image source]

In the herbal and essential oil industry, the concept of ‘compliance’ is a weighty topic. The FDA lists many herbs and essential oils as GRAS (Generally Regarded As Safe, for ingestion or otherwise), but also has not taken the time to individually analyze the data out there for every herb and oil to determine exactly what ‘medical claims’ can be made. So, they state that none should be made.

For herbs and oils labeled for internal use, they are considered ‘dietary supplements’, and the claims allowed by the FDA are statements of how a particular plant may support the normal function of an organ system.

No dietary supplements that have not been approved by the FDA to be an OTCD (over the counter drug), can ‘claim’ to ‘treat, diagnose, cure or prevent disease’. NO mentions of any disease in promoting an herb or oil for health can me made. NO assumptions that these can relieve or treat said diseases can be made.

For example. “Angelica root can be used to treat colds and flu”.

  1. A person CAN say this if they are not affiliated with any product being sold and this is just an educational writing/teaching.
  2. A person/business CAN say this if the product they are marketing has in fact been approved by the FDA to be found useful and effective for those exact things mentioned above.
  3. A person CANNOT say this if they are creating the marketing information for their homemade angelica root preparation that has NOT been FDA approved.

We must learn to always avoid medical terms, like ‘anti-inflammatory’, ‘anti-bacterial’, ‘anti-viral’. As well as disease terms, from ‘headaches’ and ‘cramps’ to ‘cancer’ and ‘diabetes’.

So what can you say? Since Angelica root is generally regarded as safe (GRAS) in it’s commonly prepared forms, you can make a quality preparation and label it as a ‘helpful support to the immune system’. We are talking about ‘supporting wellness’, not ‘curing illness’.

Terms that talk about the normal function of an organ system; like, ‘supports normal, healthy pancreas’, instead of ‘lowers blood sugar for diabetics’.

When in doubt; Don’t say it!

FDA Compliance – Why it can be frustrating

It can get overwhelming when you are constantly thinking about what we cannot say. You have to learn to read between the lines on what some things are supposed to be used for. And you can want to pull your hair out at times because it all seems so dumb.

If so many sources, personal experience and lab tested data, suggest the beneficial uses of plants for a myriad of conditions… why can’t we tell the world and help everyone, clearly and concisely? Why can’t we just ‘tell it like it is’?

As practical herbalists who are trained by real, practicing herbalists, with years of real, clinical experience and tradition passed down, seeing with our own eyes how effective herbs and oils can be when used sensibly by intelligent people… it can be very frustrating indeed to be restrained by the rules of the ever present FDA.

FDA Compliance – Why it’s so important

It is a very good thing for companies and businesses to have heavy consequences for lying to the public and selling products that could be harmful and do quite opposite of what they are promised to do. We need the FDA to enforce these rules so there is more transparency in the market place and more safety in products we consume.

Additionally, if the FDA were to say one day, “Okay guys, herbs and oils are now classified as medicine! Hooray! You can make all the medical claims your heart desires. Oh, but first you have to go to school for 8 years and become a doctor before you can recommend them to your friends. And, if you don’t become a doctor, you’ll have to go to your doctor and get a prescription for that peppermint oil you use for indigestion or the chamomile tea you drink before bed. Because they are drugs now and we have to regulate them as such.”

I don’t think I know many people who would be happy with that kind of outcome. I know, I for one, am very happy with the freedom and accessibility we currently have in obtaining herbs and essential oils for personal use. It isn’t a perfect system (what is), but it is the current system, and in an attempt to preserve the accessibility of herbs and oils for the next generation, I am going to be content in sharing about my favorite herbs and oils, AND follow the rules while I do it.

And the more you think about it, the more there really is to say about the wellness of herbs and oils, and that’s great news! I write 2 blog posts a week and strive to maintain consistent, compliant information in each and every post. It can be done. Don’t lose heart! And keep sharing. Cause everyone needs herbs and oils in their life.

Thanks for reading! If you found this helpful, or inaccurate, leave a note below!

Blessings in Christ – Kerry

NOTE: I do not claim to know all the FDA Regulations on this topic. Go directly to the US FDA government website to get all the official details on compliance and FDA approval. Not all herbs/oils are considered GRAS, but many are.

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