Raw Materials - How Clean is Clean?

Spring beauty (Claytonia virginica)

Here on my farm, I grow and harvest botanicals that are used for various products for my own purposes. If not used immediately as fresh product, they’re dried and infused in oils, honey, vinegars, and alcohol or simply stored away for teas or cold infusions. This dried material looks pristine, not a speck of dirt is noted and I inspect them thoroughly. But is it? More than once, a product I designated as ‘dried and clean’ ended up with mold or some other contaminant. In my case, it doesn’t really matter. I’m not selling product and worrying about the quality for customers so my contaminated product ends up on the compost pile and I move on. But when you consider volumes of a raw material that is needed for products down line, ensuring high quality, stable, and contaminant free products is critical.

Following Good Agricultural and Collection Practices is an important first step in preventing contamination throughout harvesting, washing, cleaning, and drying. The ‘drying’ step is particularly important and defining a specification for an acceptable condition at this stage is crucial. Harvesting and hanging product to dry upside down, possibly with circulation, is fairly common for small producers with ‘dry’ occurring when the stem will snap. In humid environments, this can take days. At this point, producers may opt to pull a sample and test for microbial and other contamination, approving or rejecting the entire lot based on the results when achieving predefined test limits. This may suffice for small lots and product that’s processed further in aseptic conditions (alcohol), but for large quantities of dried product, what is acceptable?

Large lots may require additional processing to ensure the entire lot is stable and free from microbial loads, i.e. sterilization methods. Typical methods are steam sterilization, ethylene oxide exposure, and gamma radiation. Herbalists often shy away from using such products because of product degradation and toxic residues. Infrared exposure, though, may alleviate some of these fears and yet provide a superior end product that is stable and free from microbial, fungal, and viral contaminants. Following this article is an excellent table showing the comparison of these methods compiled and shared by Phil Kaeding, SRPharmS.

Last month, Sue Marshall, founder of Netzro, and I met to discuss the use of infrared sterilization technology she developed and implemented at her company in the upper Midwest. Here it’s used to process brewer’s and distiller’s mash into upcycled ingredients among other waste stream products. (Very cool concept and company!!) The sterilization chamber consists of a drum (1000 lb capacity) in which product is tumbled while exposed to intense infrared light over a relatively short time period. These operating variables are optimized based on the condition and form of incoming material. The resulting product is ‘stable’ with little degradation in phytochemicals. By stable, I’m referring to the standard 5 log kill step and acceptable water activity levels that warrant a product free from anticipated microbial growth. A 5 log kill step means that 99.999% of colony forming units (cfus) have been inactivated by this process. Water activity (aw) is a measure of the free water within a material available to support microbial growth and is a better indicator of potential problems than moisture content. A water activity value of 0.6 renders microbial growth impossible. With appropriate packaging, product undergoing a 5 log kill step with low water activity will greatly improve product shelf life. While this process can dry and sterilize within the same cycle, it can also be used for currently dehydrated products. Imagine having access to this technology for receiving international ingredients? Rather than test quality into your lots (conducting microbial tests at receiving), expose all purchased materials to a validated infrared cycle and feel confident that your ingredients are free from contamination, minimally affected by the process, and exhibit improved shelf stability.

This summer, I hope to experiment with my own harvested product by running a small study to determine the effects of infrared exposure on phytochemicals of nettles (Urtica sp.). I’ll be sure to post the results here! In the meantime, check out the amazing things happening at Netzro.

Happy Spring!

Comparison of Sterilization Methods
Kaeding, Phil, SRPharmS, MBA (2025): Sterilization of phytochemicals

Sea Change

Greetings from a very warm western Wisconsin! The frigid temperatures of just 2 weeks ago abated and now we bask in sunshine, warmth, and the sounds of spring. It will change back again but here, we enjoy these anomalies even if they are short-lived.

Earlier this week, a news story crossed my screen titled Pfizer hires ex-FDA drug chief as top doctor published in The Hill. This constant rotation of regulator-industry is well known and supports the corruption claims that so many feel are rampant in the pharmaceutical and insurance sectors. Was it too soon to expect the current administration to correct this as they’ve stated they will ‘drain the swamp’? Do they even intend to address it or was it campaign promise that merely helped win the election? It made me consider the approval of RFK Jr. as secretary over the Health and Human Services department and how our expectations might need to change.

RFK Jr has promised to focus on nutrition, exercise, and wellbeing to combat the myriad of chronic illnesses afflicting Americans and many in the wellness sector, particularly dietary supplements, are ecstatic about this sea change. These changes are sure to affect the exploding dietary supplement industry, which in 2023 was valued at 177.5 billion USD and expected to grow at 9.1% CAGR (compound annual growth rate) according to Grandview Research. From a bird’s eye view, this sector has taken several pages from the pharmaceutical industry playbook creating ‘must need’ products designed to improve health rather than cure disease though some do make such claims illegally. And without proof of effectiveness, the opportunities are nearly infinite…to make money. Are these companies more concerned with their consumers or their pocketbooks? To me, the answer is obvious. Some will say…it’s okay to make money offering beneficial products but I question their benefit and even safety. Warning letters from the FDA reveal that many supplements are adulterated with prescription drugs to ensure an effect is noted by the consumer. Stated ‘clinical trials’ advertised by companies are often poorly designed with no peer review or verification. FDA and other federal agencies are now required to downsize leaving surveillance resources limited. Consumers of dietary supplements are facing a smorgasbord of highly marketed products with doubtful benefits and little oversight.

Several years back, blue zones were in the news, five spots with exceptionally healthy and long living individuals across the globe. Though some of the age related data has since been debunked the underlying variables that each location shared were strong social ties, mainly plant based diets, exercise, and low stress. None of them had strict regimens of exercise, supplements, or diets. Transitioning to such a lifestyle is easier for some than others, but everyone can pick an area and move towards it rather than swallowing another supplement.

Where do herbal products fit into this post? Rather that purchasing that $50 bottle of supplements, begin a practice of learning about common herbal remedies that are easily accessible or even available to grow and process yourself. Identify your own deficiencies or needs and work with an herbalist who can pinpoint ways to incorporate more whole herbs into your diet. If a supplement is recommended, research where to obtain it and be mindful of the marketing claims. Most clinical herbalists offer sliding pay scales to minimize any financial burden because they’re more concerned with the health of a client than they are about becoming wealthy.

I’m not anti supplement or anti pharmaceutical, just anti industry pushing unnecessary products for profits. If there’s a lesson to be learned from the blue zones, it’s that wellness isn’t achieved through a multi billion dollar industry, it’s attained through personal choices and simplicity.

-Anne

*This post was written without the use of artificial intelligence.

Considerations for successive harvests

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Happy New Year! Hopefully the holiday season has treated you all well and the newly arrived seed catalogs are littered with sticky notes marking important pages.

Last year, I was asked numerous times how best to handle successive harvesting of the same raw material in terms of documentation and lot number creation. Many producers grow and/or wildcraft herbs for their own products and the typical process involves selecting and harvesting the desired part of the plant, be it blossoms, leaves, seeds, or roots as they become prime for harvesting. This often occurs over days or weeks, so how does one create a ‘batch’ or lot from these successive harvests?

The GMP (Good Manufacturing Practices) for Dietary Supplements (21 CFR 111) specifies control of components used in the manufacturing of dietary supplements by requiring unique identification numbers for each unique lot of components. Defining what constitutes a batch comprised of successive harvests is more nuanced than merely purchasing a pound of the same product from a wholesaler. As with any section of the GMP, there’s not one and only one way to meet this requirement. Below are some items to consider as you define your unique lots for successive harvests.

Raw Material Specification - A raw material specification indicates the form and acceptable conditions required for every component used to make a dietary supplement. Beginning with the requirements you’ve defined, you can backtrack into a definition for what constitutes a unique batch of harvested materials. What form of raw material do you need to make your final product? It may vary depending on its intended use and you may use some in fresh form, some in dried whole leaf, or some in dried powder.

What makes it unique? A ‘unique’ batch implies some type of uniformity of the product. The most unique batch harvested is all desired product collected at the same time from the same location. But in successive harvesting, that amount may be too small to make a usable batch further down in production. Likewise, collecting that same product over a month and calling it a unique batch may represent highly variable environmental conditions. Additionally, per the regulation, a batch of components must be ‘accepted' before use and collecting over too long of a timeframe would prevent you from using that batch before it was completely collected. How you define your harvested batch should be carefully considered so that it mimics your current processing and that it meets the requirements.

Once you’ve defined your unique batch, ensure that you generate a record of every harvest activity to record date, location, and other conditions that may affect the quality of the product. Harvesting records are excellent historical snapshots of the product you collected. And finally, all of these activities should be well documented in an approved SOP (standard operating procedure) that explains the steps you take to harvest and create a unique batch of components used in your final products. Harvesting Forms are available under the GACP tab. A new harvesting form for successive harvests will be available next week.

Growing and harvesting your own botanical ingredients is possibly the most important step in ensuring the quality of your products and also the most rewarding. With adulteration and contamination of herbal components on the rise within the supply chain, remove this risk by growing your own!

It’s a great time to get your documentation in place now before spring planting and to tighten up your formulations. Feel free to contact me or Elizabeth with any questions.

~ Anne

The more things change…

Moss weathering the single digits.

The result of November’s election here in the US has elicited praise, hope, despair, disgust and probably many other emotions in between. While we wait for the implementation of promised policies, many in the dietary supplement sector are excited for the anticipated changes should Robert F Kennedy, Jr be confirmed as head of Health and Human Services. MAHA (Make America Healthy Again), the viral theme circulating through social media channels, emphasizes nutrition, exercise, dietary supplements, psychedelics for mental health, and raw milk among others. As with many things, the saying ‘be careful what you wish for’ may apply here, too.

Currently, federal regulations require Good Manufacturing Practices for the manufacture of dietary supplements, specific labeling requirements, adverse event reporting, and submissions for new dietary ingredients. These activities are designed to limit adulteration and contamination of product as well as ensure accurate and truthful identification, composition, and strength. Unlike drugs, dietary supplements do not need approval prior to marketing nor must they be proven safe and effective. In addition to focusing on dietary supplements for improved health, the new administration is also focused on cutting federal waste with the FDA in the crosshairs for significant personnel reductions and even the elimination of whole departments. Typically, increased focus means increased regulation. But could increased focus, coupled with budgetary cutbacks, actually mean less regulation, less enforcement, and greater food and supplement insecurity? Nearly everyday, we see another recall or safety alert detailing contaminated food and adulterated dietary supplements that resulted in serious illness, hospitalization, or even death. Addressing such events, with smaller budgets, is concerning to say the least. Additionally, the proposed tariffs on imports from China, Mexico, and Canada potentially place domestic wild stands of needed botanicals at increased risk of overharvesting. What ensures ethical harvesting practices other than the ethics of the collector?

It’s possible a reorganization will provide increased scrutiny on large companies, those where the scope of a potential problem would affect many states and thousands of people. It’s also possible that surveillance will be pushed to the states and perhaps small manufacturers will be exempt from some of the currently required regulations. Regardless of the path, small manufacturers, now more than ever, should develop systems to ensure their products are safe for the protection of the user and for the protection of the company. Significant policy shifts always benefit someone. Let’s hope this time the dietary supplement user is the benefactor.

Winding down

Halloween and the first snow.

For those folks who garden, wildcraft, and grow their own herbs, the first frost and snow are a change in trajectory and a realization that soon the work outside will be finished, whether you’re done or not. It’s a good reminder that as much as you plan, there are always unknowns and being flexible and accommodating is helpful. Winter is a great time to assess what worked and what didn’t from the previous growing year. It’s also a great time to read up on the regulations. Are there any new regulations affecting your business? Are you adding a new product line that is covered by a different regulation? Are there changes to state and municipal regulations? There’s little time to do this in the height of the growing and harvesting season but winter is a time for planning and adding this activity will help for the following year and beyond. Curl up next to the fire with a cup of tea (or cocktail!) and dig in to your favorite code of Federal Regulation or Guidance document with highlighter in hand. Make a list of those that are relevant to your products or a particular rabbit hole that l

Here’s a list of suggestions:
https://www.fda.gov/food/dietary-supplements/information-industry-dietary-supplements
https://www.fda.gov/food/dietary-supplements/information-select-dietary-supplement-ingredients-and-other-substances
https://www.fda.gov/cosmetics/cosmetics-guidance-regulation/cosmetics-guidance-documents

If you’re looking for something in particular and can’t find it, let me know and I’ll help you out!

Enjoy the change of the seasons and the much needed time to recharge.

~ Anne

One step forward…

New England Aster.

and maybe five steps back. In early September, Elizabeth and I attended the Great Lakes Herb Faire in Chelsea, MI, where she presented twice (on barberry and birch, respectively) and I came prepared with some key templates to assist small manufacturers in gathering herbs and manufacturing products. I was excited to discuss various schemes for meeting federal regulations. Herbal conferences are such unique events, often located in beautiful natural settings, with presentations occurring under tents, in yurts, or simply outside. Kids are cut loose and playing, unencumbered by the typical electronics. And the barter system is alive and well among vendors. It gives me hope for a simpler future. What didn’t fit well was any discussion on manufacturing regulations for botanical dietary supplements. I found a reluctance to even address regulations and a wariness that perhaps I WAS the FDA. Rest assured, this is not the case. It dawned on me that I’ve jumped too far ahead too quickly in assuming that everyone understands and accepts the requirements and I’d like to present just a few points that may offer a different perspective on them.

• Current Good Manufacturing Practices (cGMP)

Once considered “new” requirements enforced by FDA, the cGMP is now standard policy. Passed in 1994, the Dietary Supplement Health and Education Act, set forth requirements for manufacturers of dietary supplements based on their increased use, popularity, and economic impact. The dietary supplement industry, on the whole, welcomed this regulation and accepted the oversight, especially with the gift from authors Sens. Hatch and Harkin, that dietary supplements need not be proven effective or safe. In other words, dietary supplements are not approved by FDA. Rather, the oversight consists of manufacturing, packaging and labeling controls and the handling of product. The compliance dates of this requirement were staged based on company size with the final date for GMP compliance for companies employing fewer than 20 full time employees of June 25, 2010…fourteen years ago. For companies selling product for the past 20 or more years, yes, this was a new burden for them. Many companies, however, are relatively new, less than 10 years old. Understanding regulatory requirements should be part of the business plan and addressed accordingly prior to manufacturing.

• Exemptions

  There are exemptions littered throughout the regulations, unfortunately, company size is not one of them. There is no exemption for being a small company.

• Protection

  The regulations are created to protect the public from the products they purchase, ensuring with some comfort level, that they are getting what is stated on the packaging and labeling. But these same regulations also protect a manufacturer. Any consumer can file a complaint with the FDA about a product they believe caused an illness, hospitalization, or even death, without any verification. If a product you manufacture is implicated, and FDA has found reasonable cause to investigate, your records and procedures can quickly clarify the level of control you maintain and the resulting history of your products.

• Knowledge

  The better you know and interpret the regulation and apply it to your facility and products, the better you can respond to inquiries, whether it be from FDA, customers, or vendors. Feel confident in how you apply the regulation and how you defend it.

• Comfort

  For those risk averse individuals, having a well defined documented system that meets all the requirements of the GMP regulation provides a level of comfort knowing their risk of product issues or inspections is minimized.

A small manufacturer of herbal products falling under the umbrella of the dietary supplement regulation may feel restricted and overly burdened to comply with the requirements listed in 21 CFR 111 (Current Good Manufacturing Practice (cGMP) In Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements). It’s a daunting list of work and some will choose to avoid it. But most will realize that they need that documented system and in the long run will also realize the benefits of having the visibility and traceability of their components and distributed products. The hardest part will be writing that first component specification, the first standard operating procedure, the first master manufacturing record. Once you have one, the rest are easier. Just start with one!

Feel free to contact me if you’d like to discuss more. I’m always here to help!

Tallow

What is tallow and why am I writing about it? Personally, I prefer to focus on botanical ingredients and finished products, but tallow is being heavily promoted in social media circles as a beneficial topical product and many herbalists are using it in various cosmetics. Simply put, tallow is solid animal fat, typically derived from our domestic animal consumption (beef, sheep) and a byproduct of the rendering process. Tallow is used in many industries but for this post, I’m focusing on the use of it as a cosmetic ingredient, and specifically beef tallow. Recently, I’ve seen several advertisements from small herbal cosmetics manufacturers promoting their own tallow products. Many are small farmers who make the tallow themselves from their own beef, supplementing a farm raised meat business and creating additional income streams from the byproducts.

As an animal product, FDA has concerns about using cattle materials, namely the risk of BSE (bovine spongiform encephalopathy), and preventing any possibility of using infected product in food or cosmetics. BSE, a prion disease in cattle, is linked to Creutzfeldt-Jakob disease in humans, a rare but fatal brain disease, and for this reason, FDA and other agencies provide strict enforcement of cattle product regulations. For cosmetic use, these restrictions are detailed in 21 CFR § 700.27, Use of prohibited cattle materials in cosmetic products. This section specifies what is and is not allowed and these items are risk based. In some cases, FDA will exempt small or very small operations from requirements, however in this instance, there are no exemptions and every producer, regardless of size, must follow these regulations. Tallow, per this regulation, means “the rendered fat of cattle obtained by pressing or by applying any other extraction process to tissues derived directly from discrete adipose tissue masses or to other carcass parts and tissues. Tallow must be produced from tissues that are not prohibited cattle materials or must contain no more than 0.15 percent insoluble impurities (AOCS Official Method CA 3a-46), American Oil Chemists Society, 5th Edition, 1997. Tallow itself is not a prohibited cattle material when it meets this specification, but it must not be made from cattle products that are prohibited. This is clearly stated in 21 CFR § 700.27 (b) (1) “No cosmetic shall be manufactured from, processed with, or otherwise contain, prohibited cattle materials.” In 69 Federal Register 42256, FDA discusses the commercial processes employed to create tallow (hydrolysis, transesterification, and saponification) and deemed them sufficient to render the risk of transmission low. However, there are many websites detailing the process to make your own tallow at home that simply involve heating suet. If this process is used to make tallow that then becomes a cosmetic ingredient, the risk increases.

What are these prohibited cattle products? The list is based on cattle products and conditions that may harbor infection with BSE or indicate infection with BSE. The actual materials are listed in the regulation, those parts of the cattle where the prion resides, brain tissue, spinal cord, and others. The prohibited conditions are possibly more applicable to the small producer. Material taken from non ambulatory cattle, non inspected and passed cattle, and cattle over 30 months of age is prohibited which may limit the home producer if they are making tallow for commercial use. (Anything produced for individual use is NOT affected by this regulation.)

An herbalist offering cosmetics in their small commercial line may feel secure in their exempt status from MoCRA (Modernization of Cosmetics Regulation Act of 2022) requirements for registration and listing, and current Good Manufacturing Practices. But if some of the products offered include beef tallow, it must meet the specifications indicated above. When produced on site, records proving that it was manufactured free from prohibited cattle materials must be maintained. If purchased, then receiving records must prove that the product received is acceptable and free from prohibited cattle materials. Test results must be available that prove acceptable insoluble impurities and all records generated must be accessible to FDA. Though rare, the severity of BSE and Creutzfeldt-Jakob warrants the restrictions placed on this ingredient.

This week Elizabeth and I will be at the Great Lakes Herb Faire in Chelsea, MI. If you happen to be attending, please stop by our booth and be sure to attend Elizabeth’s presentation on Barberry!

Written Procedures

Second year mullein (Verbascum thapsus).

In biomimicry fashion, this represents to me a well defined documentation system with the outer leaves representing facility level procedures and the inner, smaller leaves, specific instructions required to manufacture a product. Each document plays a crucial role in producing the desired outcome, in this picture the emerging flower stalk.

Scattered throughout 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, is the phrase “You must establish and follow written procedures….”, clear in its directive, vague in details. This is good and bad. Good, in that you can define and create your written procedures however you wish. Bad, in that if you deviate too far from what is expected by FDA, your system will face more scrutiny and require more defense. What are some standard elements of a written procedure? Below are 10 items consistently used across regulated industries.

1. Approval Section - Every document should have an approval section that includes the author, approver, date of signatures, document revision, and document title. In some cases, a document number is also used to facilitate tracking. If a change control system is used, identify the change number that details the document changes.

2. Purpose - Specify what area this document is addressing. Give it a theme.

3. Scope - Identify the boundary of activities for the document. It may address what is applicable as well as what is not applicable. e.g. dietary supplement versus cosmetic goods.

4. References - Call out other relevant documents that enable the implementation of the procedure such as a form or another document. In some cases, it may reference the regulatory requirements by specifying a standard or code.

5. Definitions - List any terms that need a specific definition relevant to your process.

6. Responsibility - Identify who is ultimately responsible for ensuring the implementation of the activities specified. In some cases, it may be manager level or higher or a user level.

7. Procedure - This is the meat of the document that specifies what specific steps are needed to implement the procedure. Be as detailed as possible without being too restrictive. Procedure sections are often in outline format.

8. Records - Identify what records are generated from activities outlined in this procedure and what information they entail. This section is important as it provides proof that the procedure was followed as written.

9. Document History - As part of the document, and often at the end of the document, a brief table identifying each revision, reason for revision, and effective date provides a snapshot of how the document was modified and when the change occurred.

10. Header and Footer - This may seem trivial, but having information appear on each page completes the document. The header often includes the company name or logo and document title. In the footer is document number and current revision, and page number of total pages.

Circling back, none of these elements are specifically required by law and you can pick and choose which fit your organization. But having control over your documentation translates to control over your products and that, ultimately, gives FDA inspectors comfort. Take time to make the format of your first procedure one that can be duplicated easily throughout your system. Most importantly, create procedures that reflect what you do! The most detailed and thorough documents are worthless if you can’t or don’t follow them. Not sure where to start? Download one template from our list and edit it for your purpose. The first one is always the hardest to create!

Launching

Welcome to the first edition of Rabbit Rabbit, a monthly blog published on the first of every month. We invite you to offer suggestions and topics of interest and we’ll do our best to present our current thinking on the subject.

Small herbal companies face many challenges, one of which is maintaining awareness of federal and state regulations governing the products they manufacture. Larger companies employ quality managers, maintain a quality department, and often retain lawyers to manage this workload. Sifting through the many chapters takes hours that most owners don’t have and, frankly, prefer to avoid. This puts them immediately at a disadvantage. I’m committed to giving these small companies every opportunity to meet the regulations in a manner that works within the structure of their business.

In the unlikely event that an FDA inspector pays your company a visit, how prepared are you to discuss your specifications? Procedures? Products? Understand the regulation, know how you meet them, be prepared to defend them.

Thanks for tuning in!

Frank on takeoff.