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.