The FDA Globalization Act - Info You Need To Know

The FDA Globalization Act - Info You Need To Know

Kelly, from Southern Soapers, has gone above and beyond at keeping everyone informed on the latest from the FDA Globalization Act, along with businesses that have been cited and/or fined.

Here is the link to her website - she has some great posts on there, as well as two good lists, and also offers classes in things that you might want to take. She has been in business long enough to know what she's talking about and has several posts on her website; as well as the link to the Indie Beauty Network, Business Insurance and a good amount of other info as well. She also, I believe, has a link that will take you right to the Indie Beauty Network, which has information on the FDA Globalization Act - upcoming probably this year, though it was started in 2008, it ought to be passed in some form or another in 2009.

http://www.southernsoapers.com

She sent me, as well as the rest of her list, a notice the other day about a website that the FDA had already fined along with the link, here:

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01921.html

She received this link from Kayla, who owns and operates another website; Essential Wholesale - one that supplies materials for soap-making, lotion bases and various other things for home crafters. There are many of these sites, so chances are, there's one fairly close to you and you have to buy supplies somewhere if you're making and selling.

http://www.essentialwholesale.com

Anyways, Kayla alerted her to this. With the FDA Globalization Act going to be passed in some form or another, anyone making and selling things on the web needs to be extra careful. What with the peanut scare (which was/is all-too-true), and various other recalls, it just makes it a good idea to really watch what you put on your products, as for labeling and making darned sure that you're not making any claims that can be construed by the FDA as a medical claim.

Take real care when you're putting labels on your products and make sure that nothing you put on there can be mistaken for anything other than what you intend, and familiarize yourself with the difference. You could not only lose your business, small though it may be - you could be fined a lot of money, like the company above.

If you have a website, even if it's a free one, make sure that you don't cross that line when describing your products. Finally, when you name a product, at least do a few online searches to make sure that there already isn't a product out there with the same name. Why? Because it's probably got it's own trademark on it and you really don't want to be found in violation of that. It's the same with your website - check and re-check and make sure your web-name is unique. Same reason.

If, for instance, you claim that one of your products can help a specific illness, you are making a medical claim and are in violation of the FDA's current ruling on cosmetics-versus-drugs.

Kayla has a good write-up on her site which explains the difference between which is which, and if you go to the FDA site itself, under Cosmetics, you'll find the correct labeling instructions as well as their definitions.

Kayla's write-up, in .pdf format:

http://www.essentialwholesale.com/v/pdf/cosmeticsvsdrugs.pdf

As Kelly says, be careful what you put on your labeling; as well as how you label. Be careful of intended use of products and how you present your advertising. It could mean the difference between you having a business or not. It could also mean the difference between a huge fine or not and nobody wants to be put in that position, nor can most afford to be.

Finally and this is directly quoted from Kelly via email to me:

"I would just add a little more stressing that although many of us come into the business because we developed a product that helped a family members skin condition, we absolutely can not sell a product making such "drug" claims. That drug claims (healing, alleviating, remedying, relieving, anything that changes the structure or function of the skin or even prevents a problem from happening is considered a "drug'.) are seriously more what will get someone shut down than mislabeling what the ingredients are in their cosmetics. An example is vitamin E. Many folks actually put "Vitamin E" in the ingredient list.

The FDA says vitimins are 'heal promoting' and when you put them in the ingredient list as "vitamin e" they become the 'active ingredient', making the product a "drug". If you list the vitamin E as "tocopheryl acetate" or even "tocopheryl acetate (vitamin e)", than you are defining that the primary use of the vitamin e is COSMETIC, not DRUG. This prevents misbranding and also having your item categorized as a drug, two separate issues."

Even if you sell locally, for the most part, you may still get yourself in trouble.

Finally, another link for you to take a look at, from when this first started, in 2008, from the Handcrafted Soapmakers Guild:

http://www.soapguild.org/FDA2008.php

Thanks to Kelly, from Southern Soapers, for the info and for getting the word out. Feel free to share this info -- the more who are informed, the better off everyone will be.

Above all, be careful; be safe. Stay in business.

mn - 2009