If you’ve recently converted your distillery or brewery to make hand sanitizer, you’re probably finding the ethanol alcohol you’re using is producing incredibly offensive odors in your final product. Even worse, you’ve probably found the temporarily relaxed FDA regulations don’t allow you to add additional ingredients to remedy the tequila or rotten garbage smells.
As it turns out, our master perfumes have created a series of additive solutions that reduce these unpleasant odors in ethanol-based sanitizers. Even more, there is in fact an application process distilleries and breweries can apply for in order to add this solution while also meeting FDA regulations.
Read on to learn more about how businesses across an array of industries are shifting their focus to join the fight against Covid, how our additive solutions are helping these businesses reduce ethanol smells in their sanitizer products, and four simple steps breweries and distilleries can take to utilize our fragranced additive solutions while remaining FDA-compliant.
Turning Lemons Into Lemonade Through Coronavirus
The COVID-19 pandemic has left a lethal, unforgettable trail across America, and has affected many industries, notably perfume manufacturers such as Alpha Aromatics, and many brewers and distillers, who are collectively stepping up to the plate and addressing the hand sanitizer and sanitizer spray shortage.
An increasing number of distilleries, from small-batch whiskey upstarts across the US mainland to rum giant, Bacardi in Puerto Rico, are racing to supply the new gold; namely, hand sanitizer. According to the American Craft Spirits Association, three out of every four of its distillery members are now producing alcohol for use as disinfectant.
In many cases, as part of Distillers United 4 A Cause, distillers are offering their products for free in their local communities. Clayton, Georgia’s Moonrise Distillery, creator of whiskey, bourbon and brandies, has created a gin and aloe vera blend of hand-sanitizer for their particular community. According to a Facebook post: “We are a community of huggers and hand shakers and we want to do our part to keep that warmth around, but in as safe a manner as possible.”
In this time of terrible crisis, relevant industries are altering their manufacturing operations so that they can produce goods that are considered necessary to national security. If this seems reminiscent of language often heard during war time, that’s because in its own way, it is. The battle now is against an invisible scourge that has at this time already claimed almost 100,000 American lives.
In the same fashion as Chrysler, Ford and General Motors drastically transformed their factory lines so that they could produce air-craft and parts, trucks, tanks marine diesels, guns and shells for the military during World War II, fragrance makers such as Alpha Aromatics, distilleries and breweries today are suspending or adding to their normal operations so that they can produce hand sanitizer, which has become highly coveted and in critical supply.
The Federal Drug Administration And Hand Sanitizers
The Federal Drug Administration (aka FDA) regulates hand sanitizers as over-the-counter drugs. According to FDA Commissioner Stephen M. Hahn, M.D: “…Our continued mission is to ensure safety of these products.
It is important that hand sanitizers be manufactured in a way that makes them unpalatable to people, especially young children, and that they are appropriately labeled to discourage accidental or intentional ingestion.”
Admonitions demand that hand sanitizers be kept out of the reach of children and pets and that kids should not be permitted to use them without adult supervision.
The Distilled Spirits Council has issued warnings to all of its members about the importance of keeping alcohol-based sanitizers away from children, and it has created and posted a shareable graphic for distilleries to utilize.
Their requirements also demand that any alcohol that is designed for use as hand sanitizer must first be denatured (made unfit for ingestion by the addition of toxic or foul-tasting substances).
Distilleries And Perfume Facilities Join The COVID-19 Fight
Within the United States, Pernod Ricard in New York City, produces, imports, and markets an impressive variety of spirits and wines that include: whiskey, liqueur, scotch, flavored rum, gin, vodka, tequila, and wines.
Even more commendable is the fact that this prestigious company expects to produce about 4,000 gallons of hand sanitizer at its Fort Smith facility that will be made from a recipe provided by the World Health Organization, which consists of denatured raw alcohol, glycerin, and hydrogen peroxide.
Pernod Ricard has also expanded production of their hand-sanitizers to include their bourbon and rye distilleries in Kentucky, Texas, and West Virginia. As true patriots, all the gel will be donated to the White House task force for redistributed to hospitals and wherever else it’s most needed.
Brewers such as Budweiser-maker Anheuser-Busch have also started producing hand-sanitizer. According to one recent report, some distillers, such as: Atlanta-based Old Fourth Distillery; Rabbit Hole (Kentucky); Smooth Ambler (West Virginia) and TX Whiskey (Texas), have begun making hand sanitizer that will soon be available to their communities.
Old Fourth’s fragranced product is comprised of 95% ethanol and 5% aloe vera. In the state of Missouri, Lazy Magnolia Brewery has turned to producing hand sanitizer instead of the usual beer.
Alpha Aromatics, Hand-Sanitizer And Fragrance Solutions
Perfume companies, such as ours, are also doing their part to compensate for the critical shortage of hand-sanitizer. Like other manufacturers whose products are made by using ethanol because of the shortage of Isopropyl alcohol, they too would otherwise be dealing with the stink associated with this were they not the scent-masters that they are.
To combat those odors, our team has developed a series of FDA-compliant additives, which reduce the odors associated with ethanol, and yet at the same time, leave the hand-sanitizer with a pleasant clean scent when applied to the skin.
Sources of ethanol can be derived from raw materials such as corn, sorghum, barley, sugar cane and sugar beets. It can also develop naturally as a byproduct of grasses, trees, agricultural and forestry residues such as: corn cobs and stocks, rice straw, sawdust, and wood chips.
According to Bryan Zlotnik, Chief Operating Officer (COO) of Alpha Aromatics, when it comes to fragrance for these ethanol-based products: “The ethanol odor-reducing solutions vary depending upon the intensity of the ethanol odor and what it was made from. As a result, the solution used in a solution can be different from one ethanol sanitizer to another… Producers have only to send small amounts of their samples to our perfumers who can analyze the product, asses the correct solution and then quickly supply several options for a fragranced odor control solution that will be suitable to a particular brand. While this new additive may not be a cure-all panacea, it will certainly aid in curtailing the deadly spread of this terrible virus.”
The US Federal Drug Agency (FDA ) has eased rules by waiving dozens of regulations surrounding the manufacturing of hand sanitizers albeit they demand that the alcohol used must meet federal or international standards.
All distillers must apply directly with the FDA in order to add a fragrance to their sanitizer product to minimize shortages. They are also required to pay a fee of about $5,000 in order to add a fragrance to any hand sanitizers they may produce. If they fail to pay, they can only sell their product without extra ingredients, which means the smell will be highly unpleasant.
4 Steps For Distillers To Reduce Ethanol Odors In Sanitizers
Most enterprises involved in the manufacture, repacking, relabeling, or salvaging of a drug product for commercial distribution are required to register with FDA and list the specific drug.
The following steps are recommended for successful registration and will enable you to make fragranced hand sanitizers through the temporary relaxed FDA regulations and beyond. It should be noted that registration alone does not guarantee product approval. They include: Establishment Registration, Labeler Code Form, and Product Listing. Each step requires an initial submission, followed by periodic updates/renewals to maintain an accurate and current status.
1) Get a Dun & Bradstreet (DUN) Number
The D-U-N-S number is vital to the establishment of a company’s D&B® file, which can help potential partners and lenders learn more about the operations of a business. It can well be a factor in the decision of whether or not to work with a specific enterprise as a client, supplier, or partner.
2) Create a CDERDirect Account and Register the Establishment
While most any software can technically be used to create Structured Product Labeling registration and list SPF files, the FDA prefers Authoring Software and offers two simple and very specific tools; namely, CDER Direct and Xforms.
They are both free and the former works best with the following browsers: Microsoft Internet Explorer 8 (IE8) and above, Firefox version 28 and above, Google Chrome 44.0.2403.130 and Safari 10.0.1 and above. XForms is compatible with both Macs and PCs and no download is required. This tool also has a built-in validator that can detect about 95% of technical errors.
Then register the establishment at the Electronic code of Federal Regulations.
3) Request a Labeler’s Code
Any company engaging in manufacturing, repacking, relabeling, or private label distribution of a drug-related item must apply for a National Drug Code (NDC) labeler code by providing the following information: the name, physical and email addresses, and any other contact information related to the person for whom the code is requested; the specific type of activity for which the code is requested (ie manufacture, repacking etc) and the type of substance (drug) whether human animal or both, prescription or non-prescription or both, to which the label will be affixed.
4) Confirm The Labeler Code
Companies should contact the NDC to confirm any code they may have received. Without this step, the code cannot be used to list and sell any products. Once the labeler code is confirmed, you will have to register your formula in order to receive a NDC for their product. This is the next step in using fragrances in hand sanitizers, but is explained along the way.
Our teams at Alpha Aromatics are always there to service our many clients who are situated all over the world, and while Covid 19 will one day pass, the services we provide to those making hand sanitizers and other products are here to stay.
Submit a written inquiry or call our team today, +1 (412) 252-1012, and see how we can help you with reducing odors and adding a fragrance to your hand sanitizer product, whether made from ethanol or isopropyl, while meeting all FDA temporary and long-term regulations.
Final thought on hand sanitizers: If cleanliness is next to godliness, then hand sanitizer is my only hope for salvation ~ Josh Stern
Why Hand Sanitizers Should Not Be Made At Home
In times of crisis, human ingenuity and do-it-yourself ideas often come to the rescue, but when the issue is making hand sanitizers at home, it is better not to start, for there is not likely to be a happy ending.
The frightening and rapid spread of the corona virus has created a shortage of hand sanitizers, and buying limitations and price gouging have propelled people to make their own sanitizer using advice gleaned from questionable Internet sources.
Most of the recipes offered out there in cyber space use a mix of 91% or 99% isopropyl alcohol (also known as rubbing alcohol) and aloe vera gel, which is necessary to add moisture to the skin because alcohol will dry it out. The conventional ratio is two thirds rubbing alcohol to one third of a cup of aloe vera gel.
Even with diligent attention to details, things can still go very wrong when mixing is done outside a laboratory. This is because there is no way to control the means by which the alcohol gets diluted into the final formulation. If not enough gel is employed, the end product will dry out skin on the hands, which can further cause cracking and/or bleeding.
Our teams at Alpha Aromatics caution that making homemade hand sanitizer is not as easy as it may seem. If it is not done according to specific concentrations, results can be inferior, harsh to the skin and a complete waste of both money and ingredients.
If not enough alcohol is used, the final product will be useless, and a batch can be easily contaminated with bacteria by failing to use clean tools to mix everything together. Success can only come with the exact ratio of ingredients. Store-bought hand sanitizers contain at least 60% alcohol, which is the minimum amount required by the Center For Disease Control (CDC).
The Federal Drug Administration states: “We know people are making hand sanitizer at home, but we don’t have any verifiable information on the methods being used to prepare such products and whether they are safe for use on human skin.” As rule of thumb, if instructions from the World Health Organization are not specifically followed, making one’s own hand sanitizer just isn’t a smart thing to do.
Contact our team today — +1 (412) 252-1012
How Can Distillers And Brewers Add Fragrances To Sanitizers?
1) Get a Dun & Bradstreet (DUN) Number
2) Create a CDERDirect Account and Register the Establishment
3) Request a Labelers Code
4) Confirm The Labeler Code
Photo Credits: Pixabay