|
|
|
|
Showing posts with label PROP 65. Show all posts
Showing posts with label PROP 65. Show all posts
Thursday, January 23, 2020
January 2020 -- Useful Links for the New Year
Sunday, November 11, 2018
Keeping Up with Agency Regulations
Keeping Up with Changing Regulations
[1] FDA on "Natural"
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm456090.htm
"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."
--------------------------
[2] FDA GMPs -- TEN YEARS OLD
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.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.
2. Your quality control operations did not include approving and releasing, or rejecting, each finished batch for distribution."
My retainer clients are compliant. Are you? www.SystemsProcessingIntegration.com
----------------------------------
[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.
https://www.federalregister.gov/documents/2018/11/06/2018-24247/guidance-questions-and-answers-regarding-mandatory-food-recalls
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!
----------------------------------
[4] TWO IMPORTANT STORIES YOU WON'T SEE ANYWHERE ELSE!
[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: https://www.divinewellnessclub.com/idevaffiliate/idevaffiliate.php?id=103 -- 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: http://www.inhere.org/2018/11/06/making-health-insurers-follow-the-rules/
Please read about it, and help our crowdfunding effort. This case is quite important!
Donate here: https://fundly.com/support-natural-therapies
------------------------
And while you are at it... remember the Institute is now sponsoring a holistic and integrative IRB program for all you researchers. http://www.inhere.org/institutional-review-board/
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.
TIME RAN OUT
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: www.ProfessionalSafetyDossier.com
Here is my article about all this, posted at Open Source Truth: http://www.opensourcetruth.com/proposition-65-california-ratchets-up-cancer-repro-harm-warning-rules/
Friday, July 6, 2018
Categories of DSHEA Claims - July 2018 Newsletter
NEW RULES IN EFFECT AUGUST!
www.ProfessionalSafetyDossier.com
Call Me! 973-300-4594 No Time to Delay!
----------------------------------------------------
Categories of DSHEA Claims
While you are thinking about August's Proposition 65 Deadline, here is a summary of the FDA's web page on the types of claims that can be made for foods and supplements. [1]
Among the common claims that can be used on food ("Nutrition Facts") and dietary supplement ("Supplement Facts") labels are three categories of claims that are defined by statute and/or FDA regulations:
Health Claims
Nutrient Content Claims
Structure/Function Claims
As I've said many times... beneficial formulas are "easy." Lawful and powerful claims are not. Without being able to persuasively explain the benefit, even the best formula will not sell.
Health Claims
"Health Claims" describe a relationship between a food substance (a food, food component, or dietary supplement ingredient), and reduced risk of a disease or health-related condition. They require prior FDA approval.
Ther are 3 ways a health claim may be used on a label or in labeling (the sales information that makes up the "extended label" according to FDA) for a conventional food or dietary supplement:
1) the 1990 Nutrition Labeling and Education Act (NLEA) allows FDA to regulate health claims for foods and dietary supplements after reviewing and evaluating the scientific evidence, either in response to a health claim petition or on its own initiative (the Neuro Food Defect Claim is an example);
2) the 1997 Food and Drug Administration Modernization Act (FDAMA) provides for health claims based on an authoritative statement of the National Academy of Sciences or a scientific body of the U.S. government with responsibility for public health protection or nutrition research -- FDA has 120 days after application to allow or not; can be used during application period;
3) as described in FDA’s guidance entitled Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (Pearson v Shalala Claims), the agency reviews petitions for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation. If FDA finds that the evidence supporting the proposed claim is credible and the claim can be qualified to prevent it from misleading consumers, the agency issues a letter of enforcement discretion specifying the qualifying language that should accompany the claim and describing the circumstances under which it intends to exercise enforcement discretion for use of the claim in food labeling. There are about two dozen approved Qualified Claims. The Vitamin Consultancy offers a Health Claims Webinar describing each. http://www.vitaminconsultancy.com/webinars.php
Nutrient Content Claims
"The Nutrition Labeling and Education Act of 1990 (NLEA) permits the use of label claims that characterize the level of a nutrient in a food (i.e., nutrient content claims) if they have been authorized by FDA and are made in accordance with FDA's authorizing regulations. Nutrient content claims describe the level of a nutrient in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite. An accurate quantitative statement (e.g., 200 mg of sodium) that does not otherwise "characterize" the nutrient level may be used to describe the amount of a nutrient present. However, a statement such as "only 200 mg of sodium" characterizes the level of sodium by implying that it is low. Therefore, the food would have to meet the nutritional criteria for a “low” nutrient content claim or carry a disclosure statement that it does not qualify for the claim (e.g., “not a low sodium food”). Most nutrient content claim regulations apply only to those nutrients that have an established Daily Value... Healthy is an implied nutrient content claim that characterizes a food as having "healthy" levels of total fat, saturated fat, cholesterol and sodium, as defined in the regulation authorizing use of the claim. Percentage claims for dietary supplements are another category of nutrient content claims. These claims are used to describe the percentage level of a dietary ingredient in a dietary supplement and may refer to dietary ingredients for which there is no established Daily Value, provided that the claim is accompanied by a statement of the amount of the dietary ingredient per serving. Examples include simple percentage statements such as "40% omega-3 fatty acids, 10 mg per capsule," and comparative percentage claims, e.g., "twice the omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg)." ..."
Structure/Function Claims and Related Dietary Supplement Claims
"The Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory requirements and procedures for using structure/function claims and two related types of dietary supplement labeling claims, claims of general well-being and claims related to a nutrient deficiency disease. Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity." General well-being claims describe general well-being from consumption of a nutrient or dietary ingredient. Nutrient deficiency disease claims describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), but such claims are allowed only if they also say how widespread the disease is in the United States. These three types of claims are not pre-approved by FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim. If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim."
When you need to find your way through the bureaucratic maze that is claim-making, remember the Vitamin Consultancy... we are here to help!
--------
[1] https://www.fda.gov/food/labelingnutrition/ucm111447.htm
Among the common claims that can be used on food ("Nutrition Facts") and dietary supplement ("Supplement Facts") labels are three categories of claims that are defined by statute and/or FDA regulations:
Health Claims
Nutrient Content Claims
Structure/Function Claims
As I've said many times... beneficial formulas are "easy." Lawful and powerful claims are not. Without being able to persuasively explain the benefit, even the best formula will not sell.
Health Claims
"Health Claims" describe a relationship between a food substance (a food, food component, or dietary supplement ingredient), and reduced risk of a disease or health-related condition. They require prior FDA approval.
Ther are 3 ways a health claim may be used on a label or in labeling (the sales information that makes up the "extended label" according to FDA) for a conventional food or dietary supplement:
1) the 1990 Nutrition Labeling and Education Act (NLEA) allows FDA to regulate health claims for foods and dietary supplements after reviewing and evaluating the scientific evidence, either in response to a health claim petition or on its own initiative (the Neuro Food Defect Claim is an example);
2) the 1997 Food and Drug Administration Modernization Act (FDAMA) provides for health claims based on an authoritative statement of the National Academy of Sciences or a scientific body of the U.S. government with responsibility for public health protection or nutrition research -- FDA has 120 days after application to allow or not; can be used during application period;
3) as described in FDA’s guidance entitled Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (Pearson v Shalala Claims), the agency reviews petitions for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation. If FDA finds that the evidence supporting the proposed claim is credible and the claim can be qualified to prevent it from misleading consumers, the agency issues a letter of enforcement discretion specifying the qualifying language that should accompany the claim and describing the circumstances under which it intends to exercise enforcement discretion for use of the claim in food labeling. There are about two dozen approved Qualified Claims. The Vitamin Consultancy offers a Health Claims Webinar describing each. http://www.vitaminconsultancy.com/webinars.php
Nutrient Content Claims
"The Nutrition Labeling and Education Act of 1990 (NLEA) permits the use of label claims that characterize the level of a nutrient in a food (i.e., nutrient content claims) if they have been authorized by FDA and are made in accordance with FDA's authorizing regulations. Nutrient content claims describe the level of a nutrient in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite. An accurate quantitative statement (e.g., 200 mg of sodium) that does not otherwise "characterize" the nutrient level may be used to describe the amount of a nutrient present. However, a statement such as "only 200 mg of sodium" characterizes the level of sodium by implying that it is low. Therefore, the food would have to meet the nutritional criteria for a “low” nutrient content claim or carry a disclosure statement that it does not qualify for the claim (e.g., “not a low sodium food”). Most nutrient content claim regulations apply only to those nutrients that have an established Daily Value... Healthy is an implied nutrient content claim that characterizes a food as having "healthy" levels of total fat, saturated fat, cholesterol and sodium, as defined in the regulation authorizing use of the claim. Percentage claims for dietary supplements are another category of nutrient content claims. These claims are used to describe the percentage level of a dietary ingredient in a dietary supplement and may refer to dietary ingredients for which there is no established Daily Value, provided that the claim is accompanied by a statement of the amount of the dietary ingredient per serving. Examples include simple percentage statements such as "40% omega-3 fatty acids, 10 mg per capsule," and comparative percentage claims, e.g., "twice the omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg)." ..."
Structure/Function Claims and Related Dietary Supplement Claims
"The Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory requirements and procedures for using structure/function claims and two related types of dietary supplement labeling claims, claims of general well-being and claims related to a nutrient deficiency disease. Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity." General well-being claims describe general well-being from consumption of a nutrient or dietary ingredient. Nutrient deficiency disease claims describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), but such claims are allowed only if they also say how widespread the disease is in the United States. These three types of claims are not pre-approved by FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim. If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim."
When you need to find your way through the bureaucratic maze that is claim-making, remember the Vitamin Consultancy... we are here to help!
--------
[1] https://www.fda.gov/food/labelingnutrition/ucm111447.htm
Wednesday, June 6, 2018
Bureaucracy Getting Edgy - June 2018 Newsletter
It's Summer Soon...
Bureaucracy Getting Edgy!
- [1] Daily Values -- DVs -- for Dietary Supplements Changing
- [2] Branding Profiles and my new Systems Processing Integration Site
- [3] Proposition 65 Changes: Running Out of Time!
--------------
[1] FDA Extends Compliance, But Now is the Time to Plan!
It has been reported that the new regulations on dietary supplement and food label "Facts Boxes" have been delayed a bit, but the time to get ready is NOW! The good folks at RAPS.org [*] have made this detailed information available:
"FDA made a significant number of changes to several Dietary Reference Values (DRV) and many Reference Daily Intakes (RDI) [for Nutrient Facts panel for regular foods -rf]. As previously mentioned, the DV for dietary fiber was increased to 28g and a new DV of 50 g for added sugars was established. Other DV's that changed include:
- DRV for fat was increased to 78 g
- DRV for carbohydrates was decreased to 275 g
- DRV for sodium was decreased from 2,400 mg to 2,300 mg
Most vitamins and minerals had their RDI for adults and children age four and older revised. The vitamins and minerals for which the RDI was reduced include:
- Biotin has decreased from 300 mcg to 3 mcg.
- Chloride has decreased from 3,400 mg to 2,30 mg.
- Chromium has decreased from 120 mcg to 35 mcg.
- Copper has decreased from 2 mg to 0.9 mg.
- Molybdenum has decreased from 75 mcg to 45mcg.
- Pantothenic acid has decreased from 10 mg to 5 mg.
- Riboflavin has decreased from 1.7 mg to 1.3 mg.
- Thiamin has decreased from 1.5 mg to 1.2 mg.
- Niacin has decreased from 20 mg to 16 mg.
- vitamin B-6 has decreased from 2 mg to 1.7 mg.
- vitamin B-12 has decreased from 6 mcg to 2.4 mcg.
- Selenium was decreased from 70 mcg to 5 mcg.
- Zinc has decreased from 15 mg to 11 mg.
The following vitamins and minerals had their RDI for adults and children age four and older increased:
- Calcium has increased from 1,000 mg to 1,300 mg.
- Magnesium has increased from 400 mg to 420 mg.
- Manganese has increased from 2 mg to 2.3 mg.
- Phosphorus has increased from 1,000 mg to 1,250 mg.
- Potassium has increased from 3,500 mg to 4,700 mg.
- Vitamin c has increased from 60 mg to 90 mg.
- Vitamin k has increased from 80 mcg to 120 mcg.
Further, several vitamins will now need to be declared using different units of measure. In the case of vitamins A, D and E, International Units (IU) will be replaced by metric units, such as micrograms of Retinol Activity Equivalents (mcg RAE) for vitamin A; micrograms for vitamin D and mg for vitamin E. For vitamin D, however, IU may continue to be used in addition to mcg. Also, folate must now be declared as micrograms of "Dietary Folate Equivalents" (mcg DFE) instead of simply mcg.
The revised RDIs for these four vitamins are:
- vitamin A 900 mcg RAE (from 5000 IU)
- vitamin D 20 mcg (800 IU) (increased from 10mcg or 400 IU)
- vitamin E 15 mg (from 30 IU)
- folate 400 mcg DFE (from 400 mcg)"
[Note: these changes will have to be integrated into your label Supplement Facts boxes over the next 18 months. This website can help you with those pesky Supplement Facts calculations: https://www.recipal.com/ - rf]
[*] https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/10/preparing-for-dietary-supplement-label-changes-under-the-final-rule-for-nutrition-and-supplements-fa
---------------------------
[2] BRANDING BASICS
COMPANY BRANDING PROFILE
www.SystemsProcessingIntegration.com
What is a Company Branding Profile (CBP)? It is an organized document that is part of the Intellectual Property of the company.
The Branding Profile adds value to the company by better defining the company brand. It is a company IP asset.
The CBP needs to have a prominent position in the Company Culture since it defines, for all the Company Team Members, the details of the Brand the Company promotes and defends. It is posted as part of the Operating Process System (OPS) and is a key element in Systems Processing Integration.
The Profile covers such core marketing issues as:
- Patents and Trademarks
- Slogans
- Trade Names and Logos
- Precisely what colors represent the company
- What typeface fonts
- What types of images
- The "look and feel" of the labeling and sales copy
- Trade Dress and Branding Indicia
Substantiated advertising language should be cataloged.
The Company Mission Statement should be included.
One Branding Agency [http://duffy.agency/insight/what-is-a-brand-profile/] lists:
"The brand codification process typically involves defining and aligning elements like:
- Target audience / segments
- Target beliefs & perceptions
- Target options / competitors
- Category
- Value proposition
- Position
- Speaking points
- Personality
- Selling points
- Tone & manner
- Visual profile
- Backstory
- Brand persona
- Brand architecture
- Vision, mission, goals"
The Branding Profile is intended to offer guidance to the copywriters and customer service people in the company, as well as the planners and managers.
That is why this essential part of the company culture rightfully belongs in the OPS, as one of the chief expressions of the company's Mission.
More at: www.SystemsProcessingIntegration.com
-------------
[3] Proposition 65 Changes Just 2 Months to Go! Is Your Company Ready?
Friday, April 13, 2018
Time Is Running Out: Prop 65
| ||||
|
Thursday, February 1, 2018
California Prop 65 Services
| ||||
Subscribe to:
Posts (Atom)