What the FDA Does and Doesn't Regulate

When it comes to wellness products - especially herbal remedies, supplements, and natural cosmetics - there's often a lot of confusion about what's FDA approved, what's regulated, and what's not. Let's clear the air.

What is the FDA, anyway?

The Food and Drug Administration (FDA) is a U.S. federal agency responsible for protecting public health by regulating the safety and labeling of food, drugs, medical devices, cosmetics, and more. Its mission is to ensure that the products we consume, apply, or rely on for health are safe, effective, and truthfully marketed. While the FDA strictly regulates things like prescription medications and vaccines, it takes a much lighter approach with natural products like herbs, essential oils, and cosmetics - which often leads to confusion about what's allowed and what isn't.

What Does the FDA Regulate?

The FDA is strict when it comes to anything intended to treat, diagnose, cure, or prevent diseases. It requires rigorous safety testing and approval for:

• Prescriptions & Over-the-Counter Drugs

  must be tested through clinical trials and approved before sale

• Medical Devices

  Everything from pacemakers to pregnancy tests

• Food Products

  Oversees safety, labeling and ingredients for most foods (excluding meat and poultry, which fall under USDA).

• Vaccines & Biologics

  Extensively tested and strictly regulated.

• Tabacco Products

  Regulated for advertising, labeling, and age restrictions.

• Cosmetics (to a degree)

  The FDA doesn't require pre-approval but does regulate labeling and certain ingredients like color additives. It can take action against unsafe or misbranded products.

What Doesn't the FDA Regulate?

The FDA's involvement is minimal when it comes to products that don't make medical claims. These include:

• Herbal Supplements

  Treated as dietary supplements, not drugs. They don't need FDA approval but must carry this disclaimer: "These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"

• Essential Oils (for Aromatherapy or Topical Use)

  If marketed for mood or general well-being, they're not regulated. If claimed to "treat" anything, they fall under FDA scrutiny.

• Natural Remedies & Folk Medicine

  Unless claims are made that mimic drug language, these practices are outside FDA oversite.

• Cosmetics

  The FDA does not approve lotions, creams, or soaps before they go to market unless they include restricted or drug-like ingredients.

What Can Get a Product (or Seller) in Trouble

Even without requiring pre-approval, the FDA enforces rules that protect consumers. Here's how natural or handmade products can land a maker in serious legal trouble:

1. Making Medical or Drug Claims

   If a product label, post, or website says it "treats", "prevents", "heals", or "cures" any condition (including minor ones like anxiety, sunburn, or headaches), the FDA considers that a drug claim - and unless it's backed by clinical testing, it's illegal.

2. Misleading or False Labeling

   1. Calling a product "FDA-approved" when it's not

   2. Using vague or scientific-sounding terms to exaggerate benefits

   3. omitting ingredients or exaggerating results

   These are all red flags. Transparency is essential in labeling and marketing.

3. Selling Unsafe or Contaminated products

   The FDA (and even local health departments) can recall or ban products that contain:

   1. Harmful bacteria or mold

   2. Dangerous levels of essential oils

   3. Allergens not listed on the label

   4. Ingredients not meant for topical or internal use

4. Sunscreen Claims Without SPF Testing

   This is a growing issue in the wellness world - and a serious one. You cannot legally market a product as sunscreen unless:

5. It contains FDA-approved UV filters

   1. (like non-nano zinc oxide or titanium dioxide)

   and

   1. It has undergone lab testing to determine SPF effectiveness.

Natural ingredients like tallow, coconut oil, and carrot seed oil do not provide adequate or consistent UV protection. Calling these products "sunblock", "natural SPF", or "UV shielding" is dangerous and illegal`

Why This All Matters

The FDA doesn't regulate everything, but it does protect the public from misleading or dangerous products. As an herbalist, I take that responsibility seriously.

That means:

• I follow FDA labeling guidelines

• I avoid making medical claims

• I use safe, clearly identified ingredients

• I educate my customers so they can make informed decisions

Final Thoughts

Herbal products, folk remedies, and natural skincare are powerful tools - but they exist in a legal gray area. Understanding what the FDA does and doesn't regulate helps both herbalists and customers stay safe.

The bottom line? Just because something is "natural" doesn't mean it's automatically safe - or legal to sell as medicine. Responsible makers know the difference. And I'm here to make sure you do too.