April 9, 2018

No Comments

Final Guidance on Data Integrity – The FDA was beat to the punch by the British Medicines and Healthcare Products Regulatory Agency

Hyman Phelps MacNamara PC’s LawBlog brings us this news “Agency Publishes Final Guidance on Data Integrity – the British Medicines and Healthcare Products Regulatory Agency that is

 

As the article points out, the FDA draft guidance was published two years ago. The British [or more formally the British Medicines and Healthcare Products Regulatory Agency (MHRA)] beat the FDA and published a  guidance on “GXP Data Integrity.”  Even though the FDA has yet to finalize its guidance I’m sure someone at the FDA has been tasked to read what the British wrote, so we should too.

 

The LawBlog does a good job summing up the data integrity principals which I’ll further summarize.

  • An organization should ensure that data is complete, consistent and accurate in all its forms.
  • Appropriate data integrity controls are necessary for all systems both manual or computerized.
  • As with any system, when gaps or weaknesses are found, an appropriate corrective and preventive actions are implemented holistically.
  • The British extends the FDA’s ALCOA concept to ALCOA+; Data integrity is:
    • Attributable, Legible, Contemporaneous, Original, and Accurate,
    • PLUS
      • Complete (i.e., the data must be whole – a complete set),
      • Consistent (i.e., the data must be self-consistent),
      • Enduring (i.e., lasting throughout the data lifecycle)
      • Available (i.e., readily available for review or inspection purposes);
    • I guess they called it ALCOA+ because ALCOACCEA looks like a new latin species name.
  • Data integrity effort considers the risk to product or patient (e.g. reduced risk reduced effort; high risk high effort)
  • Systems and processes should be designed in a way that facilitates compliance with the principles of data integrity;
  • Paper systems (should be controlled as if they could be tampered with) —  for example, use of controlled books with numbered pages, may be necessary to prevent the re-creation of a paper record;
  • Using a scribe to record on another’s behalf is acceptable, providing everyone signs off and everything is done at the same time.
  • Data doesn’t need to be saved just because it can be saved. However, the exclusion of data must be justified (at a level similar to that followed by the scientific method)
  • Basic security principals, apply, such as to limit access to the minimum necessary data access for a person to perform their role; and tighter controls are needed for people with elevated (i.e. system administrator) access
  • As with all risk management systems, organizations are expected to implement, design and operate a documented system that manages an appropriate and acceptable data integrity risk.  This means the rational for acceptable risk needs to be documented, such as creating a data integrity risk assessment (DIRA)

 

 

Knowledge Bank is NOT a legal firm; The materials available at this web site are for informational purposes only. Please consult with an attorney for all legal matters.

April 2, 2018

No Comments

Gottlieb speaks. Healthy, Qualified Claims, Allergies and overall Nutrition in Focus

As reported in several places, after what some consider two-years of radio silence, Scott Gottlieb, FDA Commissioner,  addressed the Consumer Federation of America’s National Food Policy Conference in Washington DC March on 30th 2018, with a speech outlining broad changes to FDA food policy. The full video and text transcription is available on CSPAN here

 

From opening about heart disease and cancer, Mr. Gottlieb quickly reminds us that  “we can’t lose sight of the public health basics like better diet, more exercise and smoking prevention and cessation.”

 

He goes on to say ” We know today people are eating too much food fighting to make cases there still a consuming enough of certain nutrients to achieve a balanced diet.  We’re keeping all of these considerations in mind as we pursue making an update to the definition of healthy.”

 

“We will also consider how to depict healthy on the package so that consumers can easily identify it, particularly when they may not have time or the skills exam all the information on the food package. To address this we’ve had discussions about whether there should be a standard icon or symbol for the word healthy that everyone could use on food packages”

 

“We also plan to seek input on other possible changes to our nutrient content claims ……we are also interested in exploring claims are products that offer food groups which american dies typically fall short of the current recommendations; For example, whole grains, low-fat dairy, fruits and vegetables and healthy oils.”

 

“[We want]..streamlined process for reviewing qualified health claims we receive from the industry … We need to consider how to enhance the…review process. For instance, we want to be able to triage those requests according to public health significance and to prioritize the review of those that are most meaningful and most science-based. One such example…use qualified health claims linking early peanut introduction to reduce risk of developing peanut allergy.”

 

“Our intention is to prioritize those qualified health claims in the most likely to have a health benefit and data based on the strongest science…”

 

Additional resources:

 

March 20, 2018

No Comments

Kombucha lawsuits highlight risk for new products

The recent FoodNavigator article “Health-Ade lawsuit highlights continuing area of legal vulnerability for kombucha makers: sugar and alcohol levels…”  highlights the risks for kombucha makers.  Their article does a good job of covering the issues from the Bayol v. Health-Ade LLC et al case filed March 6th in Northern California against Health-Ade LLC and Whole Foods Market California, Inc.

 

The lawsuit simply says (1) the alcohol level of the fermented beverage routinely exceeds 0.5% alcohol, and thus should be classified as an alcoholic beverage.

However we have seen a similar class action lawsuit – Millennium and Whole Foods agreed to pay $8.5Million in a class action lawsuit for mislabeling the GT Kombucha as a non-alcholic drink.

 

This two cases highlight, the inherent risks when entering new product categories.  Companies should look at their entire portfolio of products and evaluate their risk. Products in new product category have greater risks.  New product categories have the greatest potential “known unknowns” – i.e. we would expect that because their new categories, we don’t know everything about them.

 

 

March 1, 2018

No Comments

New FDA Guidance – March 1, 2018

FDA has posted new guidance to help the US food and supplement businesses with compliance to the updated nutrition label regulations.  The final rule was issued May 2016 and was to become enforced July 2018 (or 2019).  The announcement is available here.

 

An extension to the deadline was proposed by the FDA. The new deadline was to be January 2020 (or 2021). We’ll have to continue to wait until “Spring 2018” for a firm and final rule on when the packaged foods and supplements will be enforced for proper nutrition labels.

While we are waiting, there is plenty of new help for the industry posted today (March 1, 2018) on these topics:

  1. Serving sizes
  2. Added sugar in honey, maple syrup and cranberry products
  3. What FDA will use as a ruler when examining a “synthetic non-digestible carb”—but no specific answers on the synthetics currently submitted for consideration

On April 26, 2018, Knowledge Bank is partnering with California Polytechnic University in Pomona, CA for a basic label training course. Check back for more details on this one-day course.

February 20, 2018

No Comments

Warning Letter Lessons for Dietary Supplements

The FDA recently issued a warning letter to a dietary supplement company;  KnowledgeBank has always recommended food and supplement companies read warning letters to gain understanding into the regulations and how the FDA approaches such situations.

Remember there are many more FDA inspections, than warning letters.   Letters result when issues do not get addressed adequately and promptly.  This particular warning letter was issued  more than 90-days after the companies original response. The letter covered three broad categories:

  1. Unapproved New Drugs
  2. Adulterated Dietary Supplements
  3. Misbranded Dietary Supplement.

Unapproved New Drugs:

As you read the letter its clear the Unapproved Drug claims are the most egregious issue — the FDA list reasons why they found the supplement was a drug:

“Examples of some of the claims that provide evidence that your product is intended for use as a drug include the following:”

  • “Chinese medicine ….”
  • “[H]as been used in Traditional Chinese Medicine for thousands of years ….”
  • “[B]ees use propolis to protect themselves from bacteria and diseases. Propolis has been around for over 40 million years and has been used by man for thousands of years ….”
  • “Propolis … contains more than 30 different flavonoids and antioxidants to help control free radicals. Free radicals are caused by waste from our body cells that increase with … infections … and toxins. The antioxidants help to neutralize the free radicals and prevent cell damage.”

Adulterated Dietary Supplement:

The FDA broadly outlines the meaning of “adulterated dietary supplement..[a] product has been held under conditions that do not meet the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (CGMP) regulations, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).”

They then go on the provide the specific reason why the product was adulterated:  “As a distributor that contracts with a manufacturer to manufacture, package, and label dietary supplements on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution

Finally the FDA provide examples as to how the distributor’s procedures (such as failure to open the incoming packages) could not possibly allow the distributor to  make informed decisions about their product.

“your written procedures for quality control operations do not include quality control functions such as reviewing documentation from the manufacturers with whom you contract relating to how the products you release into commerce are manufactured and whether they conform to established specifications.”

“your firm must collect reserve samples for each lot of packaged and labeled dietary supplements that you distribute, and hold the samples in accordance with 21 CFR 111.83(b)”

“You failed to establish and follow written procedures for fulfilling the requirements for returned dietary supplements, as required by 21 CFR 111.503”

Misbranded Dietary Supplement:

Misbranding boils down to errors on the label itself.

  • Not labeling parts of the plant:
    • “the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
  • Incorrect or inconsistent serving size:
    • “Take 1 capsule twice daily,” but the serving size lists “2” capsules.
  • Not recognizing some words like “Good” or “Rich” have regulatory meanings:
    • “Propolis is a rich source of minerals, vitamins C, E, provitamin A, and B-Complex ….” To bear “rich in” claims, a product must contain 20% or more of the RDI or DRV of the nutrients that are the subject of the claim, in accordance with 21 CFR 101.54(c)

 

 

February 1, 2018

No Comments

FDA Guidance and Opioid Cessation Unapproved Drugs

This week Hyman, Phelps, McNamara PC, in their FDA Law Blog, summarizes two recent FDA events, and provides some insights into their impact. I’ll provide a top line summary.  But you should read the the full articles if you want to understand the background.

  • Guidance on Guidance
    • Essentially the FDA has issued guidance documents.
    • Guidance is supposed to be just that guidance and not legally binding.
    • However guidance has been cited as a reason in FDA Warning Letters, which makes guidance, tacitly, an enforceable regulation.
    • Now theres some push back, the DOJ announced that it will prohibit DOJ from using its civil enforcement authority to convert other agency guidance documents into binding rules.
    • That’s huge!!!   In short this suggests, that an agency can’t use a guidance document to create a new enforceable regulation!
  • Joint Action by FDA and FTC Against Companies Marketing Unapproved Opioid Cessation Products
    • The FDA and the Federal Trade Commission (FTC)  jointly posted warning letters to 11 marketers and distributors of opioid cessation products.
    • Releasing double-digit letters together emphasizes their seriousness of the issue.
    • The FDA rules are clear, dietary supplements and homeopathic remedies, cannot make drug claims.
    • A drug claim treats a disease. Per 21 CFR 109.93(g) a “disease” is damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.”
    • Opioid addiction is a  disease; and prevents the body from functioning properly (i.e. addiction is not normal)
    • As such the 11 companies, are selling unapproved drugs. They have 15 days to respond.

As always please consult your attorney; this information is not intended as legal advice. Knowledge Bank is not a law firm nor do we provide legal advice.

Picture – Justice Department

January 23, 2018

No Comments

FDA Posts “DRAFT” guidance on product recalls

January 17th the FDA, posted draft guidance for Recalls:  “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff.”

The draft covers all areas of the FDA. Here we’ll highlight some salient points  Food and Dietary Supplement, but by all means read the full posting to see examples for other FDA categories here.

For reference here’s the link to 21 CFR Part 7

FDA Commissioner Scott Gottlieb statement —

Today we published a draft guidance that better describes the FDA’s policy on public warning and notification of recalled products as part of our effort to ensure better, more timely information reaches consumers. Although we often hear the most about recalled food, this guidance also covers other FDA-regulated products including drugs, medical devices and cosmetics.

 

Specifically, the draft guidance outlines circumstances when a company should issue a public warning about a recall, describes the general timeline for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient.  (Gottlieb’s full statement)

 

Under what circumstances should firms issue public warnings?

Public warnings are for urgent situations to alert the public that a product being recalled presents a serious hazard to health, and where other means for preventing the use of a recalled product appear inadequate  A public warning is also often needed when a recalled product has been widely distributed.

Examples of Food recalls

The following Food recalls present examples of serious hazards to health such that a public warning may be warranted:

  • Recalls of food products initiated by a firm after receipt of consumer reports of illness or injury (including allergic reactions), for which there is an active outbreak associated with the product or its ingredients, or for which FDA has substantiated reports of illness or injury.
  • Recalls of food products that are intended for or would more likely be consumed by vulnerable populations. Examples of vulnerable human populations include infants, toddlers, the elderly, pregnant women, and medically-compromised individuals, who may be more susceptible to foodborne hazards than healthy persons.
  • Recalls of food products initiated because of manufacturing deviations where the consequences of the manufacturing deviations could have significant health impacts; e.g., under processed low-acid canned foods which could result in botulism if the product is consumed.
  • Recalls of food products initiated because of microbiological pathogen findings (e.g., Listeria monocytogenes, Salmonella, etc.) in environmental testing where direct food manufacturing contact surfaces are found to be contaminated.

Who prepares public warnings?

Since firms are “expected” to have a recall strategy 21§7.42(b), firms themselves may issue a recall, but the FDA continues to reserve the right to ensure a recall addresses, “among other things, whether a public warning is needed and how it will be issued.”  The FDA maintains the right to protect public safety as such “If a firm issues a public warning that is deficient in any respect the FDA may supplement or correct that warning with its own public warning.”

What should a public warning include?

The purpose of a public warning is to alert the public that a product being recalled presents a serious hazard to health.  Public warning should be brief and concise and include:

  • Headline:
    • The headline of the public warning should include the brand name, type of product, and the hazard prompting the recall (e.g., “XYZ chocolate chip cookies recalled for potential Salmonella contamination.”).
  • Identity:
    • information to help identify the recalled product including images, codes (e.g., lot number, expiration date, serial number, unique device identification (UDI) number), packaging information or brand names;
  • Geography:
    • the geographic areas and dates of distribution of the product;
  • Defect/Hazard Description
    • a thorough description of the product defect, health hazard involved and reason(s) for recall (e.g., product testing, environmental sampling, etc.);
  • Name/Contact Information
    • the name and contact information for the recalling firm;
  • Consumer Instructions
    • instructions to consumers or users;
  • Defect details
    • the number and nature of any illnesses/injuries/complaints associated with the product; and
  • Illness description
    • a description of common symptoms of any illness of concern.

What NOT to include in  a public warning?

  • Nothing extra:
    • Nothing should detract from or defeat the purpose of the warning.
  • Nothing to diminish the hazard
    • Phrases such as “an abundance of caution,” that can be seen as trying to minimize the hazard, should not be used

How are Public Warnings Distributed and Displayed?

Firms and FDA can alert the public about a recall by various means, including (A) issuing press releases to the media, (B) sending emails to a listserv or subscription service, and (C) posting on FDA and company websites or social media. All of these methods could be used to issue a public warning.

Where are recalls reported?

FDA provides public access to information on recalls by posting a listing of recalls according to their classification in the FDA Enforcement Report.

January 22, 2018

No Comments

Do-it-yourself Guide to Organic Certification Fact-Checking

Shoppers buy from farmers markets to  support local businesses and farms, and buy the fresh organic produce and home made products.

But just because the farmer says its organic doesn’t mean it is organic, especially since food fraud is on the rise.  (See Two Huge Cases of Organic Food Fraud)

Even Congress is looking to fund the USDA to fight fraud.

So what is a local consumer to do?

A colleague brought to our attention this wonderful consumer Farmers Market Organic guide for  do-it-yourself verification of the Farmers Market sellers’ claims. (see also Cornucopia’s posting)

 

 

January 21, 2018

No Comments

Planned Food Regulations for 2018

The Federal Government, publishes their Regulatory Agenda’s semi-annually. This Fall’s 2017 agenda has been published  January 12, 2018 Federal Register – “The agenda describes the regulatory and deregulatory actions that are under development or recently completed for each agency.” The complete agenda can be found on reginfo.gov.

For your convenience, KnowledgeBank is filtered the list, to show only regulations impacting the Food and Supplement Industry

 

Agency Agenda Stage of Rulemaking Title RIN
HHS/FDA Proposed Rule Stage Laboratory Accreditation for Analyses of Foods 0910-AH31
HHS/FDA Proposed Rule Stage Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease 0910-AH43
HHS/FDA Proposed Rule Stage Current Good Manufacturing Practice for Outsourcing Facilities 0910-AH61
HHS/FDA Proposed Rule Stage Updating Public Information Regulations 0910-AH69
HHS/FDA Proposed Rule Stage Revision of Product Jurisdiction Regulations 0910-AH71
HHS/FDA Proposed Rule Stage The Food and Drug Administration Food Safety Modernization Act; Removing Written Assurance Requirements From the Customer Provisions in Certain Implementing Rules 0910-AH77
HHS/FDA Proposed Rule Stage Suspension of Registration of Food Facilities 0910-AH79
HHS/FDA Proposed Rule Stage Permanent Listing of Color Additive Lakes 0910-AH80
HHS/FDA Proposed Rule Stage Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size 0910-AH83
HHS/FDA Proposed Rule Stage Format and Content of Reports Intended to Demonstrate Substantial Equivalence 0910-AH89
HHS/FDA Proposed Rule Stage Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and E 0910-AH92
HHS/FDA Proposed Rule Stage Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, Extension of Compliance Dates for Subpart E 0910-AH93
HHS/FDA Final Rule Stage Label Requirement for Food That Has Been Refused Admission Into the United States 0910-AF61
HHS/FDA Final Rule Stage Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods 0910-AH00
USDA/AMS Proposed Rule Stage National Bioengineered Food Disclosure Standard 0581-AD54
USDA/AMS Proposed Rule Stage NOP; National List Amendments, Proposed Rule 0581-AD60
USDA/AMS Proposed Rule Stage NOP: Organic Livestock and Poultry Practices 0581-AD75
USDA/AMS Final Rule Stage NOP; Organic Livestock and Poultry Practices 0581-AD44
USDA/FNS Final Rule Stage Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements 0584-AE53

January 19, 2018

No Comments

National Organics Standards Board – Substance Update January 2018

National Organic Standards Board (NOSB) is proposing to:

  1. change the use restrictions for seventeen substances allowed for organic production or handling on the National List:
    1. micronutrients; chlorhexidine; parasiticides; fenbendazole; moxidectin; xylazine; lidocaine; procaine; methionine; excipients; alginic acid; flavors; carnauba wax; chlorine; cellulose; colors; and, glycerin.
  2. add sixteen new substances on the National List to be allowed in organic production or handling:
    1. hypochlorous acid; magnesium oxide; squid byproducts; activated charcoal; calcium borogluconate; calcium propionate; injectable vitamins, minerals, and electrolytes; kaolin pectin; mineral oil; propylene glycol; acidified sodium chlorite; zinc sulfate; potassium lactate; and, sodium lactate.
  3. prohibit the botanical pesticide, rotenone, for organic crops

Source: Federal Register

For more background see the National Organic Program.