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!