Sunday, November 11, 2018

Keeping Up with Agency Regulations

November Vitamin Consultancy eNewsletter
Keeping Up with Changing Regulations

[1] FDA on "Natural"

"Although the FDA has not engaged in rulemaking to establish a formal definition for the term "natural," we do have a longstanding policy concerning the use of "natural" in human food labeling. The FDA has considered the term "natural" to mean that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food. However, this policy was not intended to address food production methods, such as the use of pesticides, nor did it explicitly address food processing or manufacturing methods, such as thermal technologies, pasteurization, or irradiation. The FDA also did not consider whether the term "natural" should describe any nutritional or other health benefit."



The Natural Products Association is engaging in a tenth year review of the FDA dietary supplement GMPs.  Some valuable information is being developed.  One bottom-line point:  there is a new FDA emphasis on adequate Quality Assurance, which means specific staff members tasked with that role.  QA must sign off on all product batches and the person signing off must not be the person overseeing the production.  This applies to both manufacturers and to the label-owner who is expected to "be in a state of control."

For example, a recent warning letter to a label owner which was sent to me for review cited two violations of QA
"1. Your quality control operations did not include determining whether each finished batch conforms to established product specifications.

2. Your quality control operations did not include approving and releasing, or rejecting, each finished batch for distribution."
Remember, these points were raised directly with the label-owner, not the manufacturer.  Bottom line:  Do you have Product Specifications? Do you have a person responsible for QA?  Is QA included in your SOPs.

My retainer clients are compliant. Are you?


[3] FDA Mandatory Food Recall Authority

November 5, 2018 - The U.S. Food and Drug Administration has released a final guidance regarding the agency’s mandatory recall authority under the FDA Food Safety Modernization Act (FSMA).

"The 2011 food safety law gave FDA mandatory recall authority for foods if there is a reasonable probability that the food is adulterated or misbranded under certain FDA authorities, and that the food could cause serious illnesses or death. FDA must give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall. Prior to the enactment of FSMA, FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products.

Comment: you may recall that Dr. Laibow and I fought hard in 2010 and 2011 to preserve Section 1011 of the food "safety" bill, a section that exempted DSHEA dietary supplements from the "enhanced" authority of the law.  We were denigrated when we worked through one late-nights weekend to get over 150,000 emails to the congressional conference committee, assuring that the exemption clause would stay in the law.  Now we see the results:  "mandatory" recalls based on mere "reasonable probability..." will become the norm for most foods, but not for DSHEA products!



[1] What Happened to that Sore on My Chest?

I love to tell my list about success stories in the natural products market.  Dr. Walter Wolf is one of those geniuses that I've had the privilege to know.  He is an alchemist and naturopath.  His new product, Divine Wellness, is amazing!

Ethically harvested ovine placenta, CBD hemp oil and Nano Gold.  This is an immune boosting rejuvinater nutrient combination.

But I want to tell you about an "off label" use of the product.  A few months ago I noticed a "beauty mark" on my chest had begun to enlarge and become lesion-like. That was concerning so I started putting a varying combination of CBD hemp oil, apricot seed extract, tea tree oil and nano silver on it.  The growth stopped, but it remained.  Then, a few days ago, I begin putting Divine Wellness on the spot.

As the series of images show, it quickly puffed-up, became quite dark, and is now flaking-off.

Amazing!  Learn more about this natural product as a dietary supplement here:  -- yes, you can join the affiliate program.

[2] Horizon v Jonuzi et al. This may be the most important lawsuit pending in the USA regarding Insurance Industry reimbursement for holistic and integrative treatments and therapies... including dietary supplements as Medical Foods.  This pending litigation can construe the Affordable Care Act to forbid insurance carrier discrimination against holistic and integrative practitioners, permitting proper insurance coding for such therapies.

From the standpoint of the Mission of the Institute, this change would facilitate retrospective research into holistic and integrative modalities (through coding statistics). That's why I've helped to set up a crowdfunding effort.

Read more here:

Please read about it, and help our crowdfunding effort.  This case is quite important! 

Donate here:

And while you are at it... remember the Institute is now sponsoring a holistic and integrative IRB program for all you researchers.

My experience will strengthen your company!  I provide private and confidential, competent electronic professional consulting to my Dietary Supplement and advanced healthcare ("CAM") modality clients, for the purpose of compliance with International, State and Federal (including FTC and FDA) standards for communicating about the advertising and sale of dietary supplements (including medical foods) and/or providing of health care services and information. You should consider my SOP / cGMP Certification Course, allowing start-up and established vitamin companies and practitioners who own their own private labeled products to meet with new FDA procedural regulations.


If you think you have enough time to get ready for California's new, tougher, Proposition 65 warning rules, you are wrong. The new rules 2 months ago. If you think your product does not get into California, think again. If you think no one will notice, remember that Prop 65 is enforced by a hoard of private lawyers looking to grab fees and penalties from your company.

More information on how Dr. Goodman and I can help:

Here is my article about all this, posted at Open Source Truth: