Marie Gale

Helping soap and cosmetic handcrafters navigate the rules and regs.

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What’s the Worst That Could Happen?

I’ve talked in the past about the dangers and pitfalls of making medical claims for soap and cosmetic products. Over and over, handcrafters have asked me: “What’s the worst that could happen?”

Worst Case

Well, the worst-case scenario possibilities are:

  • Seizure of one’s products
  • Unannounced inspections of one’s facility
  • Warning letters
  • Shutting down one’s business
  • Indictment
  • Trial
  • Fines
  • Imprisonment

An Amish handcrafter named Sam Girod had his products seized (see U.S. Marshals seize unapproved and misbranded drug products fom Missouri distributor), has been indicted by a Grand Jury, and now faces possible fines and jail time if found guilty at trial.

Granted, this man was making claims that his product would cure cancer and then refused (with physical violence) to allow anyone to come into his facility (home) to inspect.

I’m pretty sure that answers the question, “What’s the worst that could happen?”

Much Better Case

On the other hand, it is more likely that if you cooperate with the FDA, make the changes requested to your labels and website, and get Good Manufacturing Practices in place, they will go away and leave you alone.  At least for a while.

See this blog post from Brambleberry: A Surprise Visit from the FDA about the experience of Robin, from River Country Soapworks.

What to do:

How do you stay off the FDA’s radar, and how can you be prepared in case they do show up for a surprise inspection?

  • Don’t make drug claims for your products or their ingredients.
  • Label your cosmetic products correctly including the net weight and ingredient declaration.
  • Don’t use unapproved color additives in your cosmetic products.
  • Implement and maintain Good Manufacturing Practices.

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    Discussion

    15 responses to “What’s the Worst That Could Happen?”

    1. Penny

      I have a chance of putting a small bag of soaps, lotions and shampoos and conditioners in bed and breakfast, but I want to make sure I am legel. What do I need to do as on labeling, other things I needs to do .

      Reply
      1. Marie Gale

        If the set of products is going to be SOLD, then you need the OUTSIDE of the bag to include all required labeling (what’s in the bag, exact content amounts in ounces and grams/mL depending on the products), business name and address and ingredients for EACH PRODUCT.

        If the products are going to be sold individually, all the required information must also be on the product labels.

        If they are being given as room amenities, and are NEVER being sold, I don’t think you need all the details – just enough to identify the product for the consumer. However, best practice would be to put full label informations on them anyway.

        I’d suggest you get my Labeling Book (if you don’t have it) so you can determine exactly what needs to go on each product label and/or the outside of the bag.

        Reply
    2. Sally Oh, FDN-P

      Thank you for this website. I was wondering how to stay out of FDA crosshairs 🙂

      Reply
    3. Barbara Paine

      Good Lord, he also claimed that his products would cure cancer.

      Reply
      1. Marie Gale

        Yes – you really have to push the envelope in order to reach worst case scenario.

        Reply
      2. Sally Oh, FDN-P

        He has actual testimonials from people who did cure skin cancer using his products. He sold the products for almost 20 years.

        Reply
        1. Marie Gale

          the problem is that even if the products have helped or cured people, the current LAW requires that drugs be approved by the FDA before being marketed. It may not be the best system, but it is the system that we have at present.

    4. Allen

      Magnificent website. Lots of helpful information here.

      Reply
    5. Blu

      I wouldn’t use that gentlemen as an example. He changed store name several times evade fda standards for years, they have been watching him , His products burned his customer, he refused fbi admission to his shop to look at things. Had a 4 hour stand off with the cops and fbi and caused witness tampering, by threatening the victim and her family. The one story people are posting that he was just an innocent person selling is false.

      Reply
      1. Marie Gale

        That’s true, this case has quite a number of very unique issues. The bottom line, though, is that if you fight the feds over labeling and claims, this is an example of the worst thing that could happen.

        Reply
      2. Sally Oh, FDN-P

        You might want to read the entire case before speaking. He complied. He just didn’t kiss the ring. Entire story is here: bit.ly/freeamishsam (that’s a change.org petition).

        Reply
        1. Marie Gale

          Your coverage of the case in the Kentucky Free Press is excellent.

        2. Tia

          Hardly what I’d call unbiased reporting.

    6. Marshalla Ramos-Inde

      I have a question about adding foods such as annatto, turmeric, fruits and/or vegetables which I do often to my handcrafted soaps. They create a color in the finished product but I add them for the love of making interesting looking soaps and feel that natural soaps should contain skin-loving ingredients that we already contain in our cupboards. Adding these food items are not listed with the exception of annatto and turmeric on the FDA website as being approved colors. I have your book on labelling and don’t see this addressed in the book as well. How should I label these items? As of now I use the common name of the item. Also, would the FDA have a problem with those items being added?

      Reply
      1. Marie Gale

        If the ingredient is on the FDA’s list of approved color additives, it may go at the end of the ingredient declaration, after all other ingredients, regardless of the amount.

        If the ingredient is not on the list of approved color additives, it should be places in the ingredient declaration in descending order of predominance (exact that ingredients present at 1% or less may be place in any order after ingredients present at more than 1%.

        Keep in mind that for cosmetics, only approved color additives may be used. A color additive is defined as anything that changes the color of the product. Even things that are used for other purposes and changes the color are considered color additives unless the color is clearly unimportant to the design, value, marketability or consumer perception.

        Reply

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