fda Archives - Soap Queen

Bramble Berry’s Essential Oil Philosophy

August 2, 2017 Filed Under: Tips & Tricks

Information about essential oils is everywhere you look. Just one online search turns up 68 million results and counting. Each result says something different about essential oils – the way they smell, where they originated, what they claim to do. One source says bergamot essential oil helps with anxiety and clears the skin, while another source says petitgrain essential oil helps boost the immune system.

You may notice our essential oil descriptions look a little plain compared to some – you won’t see any information about them boosting the immune system. There’s a very specific reason why that’s missing from the page.

Bramble Berry’s essential oil descriptions
The descriptions usually include what the essential oil smells like, how it’s distilled, its country of origin, its botanical name, what part of the plant it’s from, its flashpoint, and any safety information. For instance, Lavender 40/42 Essential Oil is steam distilled and originates in France. Lavender is also thought to alleviate headaches, heal burns, etc. However, these are drug claims.

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COHE Briefing Call – Febuary 16th

February 9, 2017 Filed Under: Business Musings

The Coalition of Handcrafted Entrepreneurs works on small business and FDA issues. This is a brief update to bring you up to speed on legislative issues regarding potential cosmetic regulatory reform. With the political transition currently, there are a lot of unknowns legislatively. The Senate Health, Education, Labor and Pensions (HELP) Committee held its cosmetics hearing in September, 2016, and while no announcements were made, it appeared that there was a consensus on the part of senators who participated in the hearing that they would attempt to pass legislation at some point in the future. Senators Collins (R-ME) and Feinstein (D-CA) continue to push their legislation, S.1014, the so-called “Personal Care Products Safety Act.” Representatives Frank Pallone and Leonard Lance, both of New Jersey, continue to work on the “discussion draft” they released in September. Finally, Pete Sessions has re-introduced the Safe Cosmetics Modernization Act. It is unclear what the change in the White House will do for the regulatory regime overseeing cosmetics.

UPDATE: Representative Pete Sessions of Texas has re-introduced legislation, H.R. 575 or the “Cosmetics Modernization Amendments of 2017,” that would amend existing laws regarding cosmetics regulations. The bill is nearly identical to the one he introduced last Congress, “The Safe Cosmetics Modernization Act.” H.R. 4075 The effort by Representative Sessions is the first of what is sure to be several initiatives that have the potential to impact the handcrafted industry. Read more about it here.

On Thursday, February 16th (one week from today), there will be a COHE briefing call at 11 a.m. PST. In this briefing call, we will discuss what we expect in 2017 and how you can help the discussion. Don’t hesitate to join the conversation and stay informed on the issues that may impact your small business.

Dial-in: 712-832-8327
Access Code: 6344642

If you have any questions to submit for the briefing, please submit them through the Contact Us page here. Want to receive updates in your email, regarding proposed small business legislation? Sign up for COHE here.

Understanding FDA Cosmetic vs. Drug Claims

September 9, 2015 Filed Under: Business Musings, Tips & Tricks

To sell soap and cosmetics, understanding the rules of making claims about your products is key. These rules and regulations, created by the FDA (Food and Drug Administration), are put in place for the safety of consumers. Soap and cosmetics should not make claims that could confuse the product with a drug. The FDA regulates and defines cosmetics, drugs and soap differently. It can be a little tricky to understand these definitions and what type of claims are appropriate for cosmetics, drugs and soap.

It’s important to first understand the difference between a cosmetic and a drug, as defined by the FDA. According to the FDA website, the law defines a cosmetic as:
“The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.”

In contrast, the law defines a drug as:
“The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].”

To summarize this statement, a cosmetic is a product that is used to beautify, or alter the appearance. A drug is a product intended to diagnose, treat or prevent a disease. A product is also considered a drug when it is intended to affect the function of the body.

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Join the Coalition of Handcrafted Entrepreneurs

March 5, 2015 Filed Under: Bramble Berry News, Business Musings

Prior to starting Bramble Berry, I sold soap at local farmers markets. I loved the personal interaction with customers and offering them a premium handmade product. Once Bramble Berry became a reality, my focus shifted to helping other entrepreneurs grow and stabilize their small businesses.

Selling handmade soap at a local farmers market.

Supporting small businesses in the soap and cosmetic industry has become a top priority of mine. I have experienced the power of this industry first hand, and continue to watch small, soapy businesses change lives. According to a recent industry survey, the Handcrafted Cosmetics Industry is comprised of at least 220,000 small batch producers in the United States. Specifically, more than 95% of those businesses are owned by women.

Currently, cosmetics including handcrafted cosmetics and soaps are regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetics Act and the Fair Package Labeling Act. These laws are in place to protect consumers from unsafe and/or mislabeled products. Over the last several years, legislative proposals have been introduced in Congress that would create new regulations on the cosmetics industry. Unfortunately, some of these new proposed rules would negatively impact small business, including new requirements for manufacturing, products, ingredients, labeling and collection of fees. Click here to learn more. I’ve worked on these issues, along with others including Lela Barker, Donna Maria Coles Johnson, Debbie May, Leigh O’Donnell, Kayla Fiorvanti for over 7 years and want to take the next step in formalizing that work.

To help protect small businesses from harmful policy changes, I started the Coalition of Handcrafted Entrepreneurs. By joining the COHE, you will receive updates on legislative proposals to stay informed and empowered. The COHE enables the voices of small business owners to be heard with calls to action that will help lawmakers make more informed decisions. Click here to join The Coalition to receive updates and information about how you can help and stay informed. It’s free. And, I won’t share your information with anyone. Promise.

In December of 2014, the COHE team and I traveled to Washington D.C. to meet with lawmakers. In particular, time was spent providing feedback about changing cosmetic regulations to Senator Dianne Feinstein’s staff. The COHE team stressed that while we support legislative provisions that protect the consumer, the unique nature of the industry requires protection for the jobs and economic development the industry supports. While progress was made, legislation affecting the cosmetics industry will continue to be explored. We must be vigilant in voicing our opinions on how future changes could affect our industry. Join me!

Update: PO Box Label Petition

January 12, 2015 Filed Under: Business Musings

In November of 2012, I blogged about the Citizen Petition filed with the FDA by the Handcrafted Soapmakers Guild (now known as the Handcrafted Soap & Cosmetic Guild). The blog was about the current regulation of requiring a home address on the label of cosmetic products. The petition requested that the FDA allow a PO Box address on the label, in place of a physical home address. Many small business owners run their business in their home and some are concerned that placing a home address on the label of a product introduces personal risk. Replacing the business address with a PO Box would eliminate this risk.

UPDATE 9/19/2017: The FTC has updated regulations concerning business name and address. The NEW regulation says the street address may be omitted if it is listed in a readily accessible, widely published, and publicly available resource. Read more here.

Since November of 2012, the HSMG filed an Amendment of Citizen Petition with the FDA on November 6, 2014. You can find the amendment here. This document briefly recaps the past events, including the response on February 1st, in which the Acting Director of the Office of Cosmetics and Colors stated they were unable to reach a decision. The amendment also presents new information, including the decision to change the name of the Handcrafted Soapmakers Guild, to the Handcrafted Soap & Cosmetic Guild.

Two years later, the Handcrafted Soap & Cosmetic Guild received a final response to the petition. The FDA denied the petition. You can read the final response from the FDA here. Bottom line, the FDA did not agree that a PO Box address would be a suitable alternative to a street address. The response reads:
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