June 26, 2017

Is That Really FDA-Approved?

When you see the words "FDA Approved" on a product, what does that mean? The FDA is a government agency that is responsible for protecting the public health. It regulates human drugs, biologics, animal drugs, medical devices, tobacco products, food, cosmetics, and electronic products that emit radiation. Not all of those products are reviewed for safety and effectiveness by the FDA before thy are marketed. FDA enforcement efforts often focus on products that are already available to consumers. The FDA can act when safety issues and problems arise. The FDA does not approve companies, health care facilities, labs, or manufacturers. Owners and operators of domestic or foreign food and drug companies must register their facilities with the FDA. The FDA approves new drugs and … [Read more...]

FDA Confirms Belladonna in Homeopathic Teething Products

Last year we told you about a consumer warning issued by the FDA regarding homeopathic teething products that had inconsistent levels of belladonna, which is considered a toxic substance. On Friday, the FDA released a report stating that elevated levels of belladonna have been found in those products; sometimes "far exceeding the amount claimed on the label." The government investigated more than 400 reports of adverse effects linked to those products, which ranged from "seizure, death, fever, shortness of breath, lethargy, constipation, vomiting, sleepiness, to tremor, agitation, and irritability." The FDA has contacted Standard Homeopathic Company in Los Angeles, the maker of Hyland's homeopathic teething products made with belladonna. The company has not agreed to a recall. So … [Read more...]

Cookie Dough Maker Gets Listeria Warning Letter

The FDA has sent the owners of Aspen Hills, Inc., makers of ready to eat cookie dough, a warning letter on January 10, 2017 about environmental samples from their facility that tested positive for Listeria monocytogenes. There is zero tolerance for that pathogenic bacteria in ready to eat products. That means that the cookie dough pucks, pellets, and pails are adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act. Four positive environmental swabs were collected in the manufacturing areas. And between September 18 and 26, 2016, the firm's environmental program found Listeria monocytogenes in ten environmental swabs and in one finished product lot of cookie dough, which was not distributed into commerce. These findings indicate that the "firm is not taking … [Read more...]

Whole Foods Closes Distribution Kitchens

A warning letter sent to the North Atlantic Whole Foods Market Kitchen in June 2016 listed problems at that facility that included the presence of non-pathogenic Listeria bacteria. Whole Foods has just announced it is closing some of its food distribution kitchens on the East coast. The warning letter detailed 20 "serious violations of the FDA's Current Good Manufacturing Practice regulations for manufacturing, packing, or holding human food." These violations included employees mixing ready to eat pesto directly under an area where condensate from ceiling joints was dripping onto the surface below; cutting chives and beets under a leaking condensate drainage pipe, and holding uncovered ready to eat egg salad in barrels placed below a condenser that was dripping. In addition, … [Read more...]

Shrimp Lovers: High Antibiotic Levels and Origin Cause for Concern

Do you know where that shrimp in your freezer or on the plate in your favorite restaurant came from? And do you know what's in it? Research in the last few years has found that antibiotic use in shrimp farming, especially in Asia, could pose a serious threat to public health. A study in 2003 published in the International Journal of Food Science and Technology, titled "Antibiotic use in shrimp farming and implications for environmental impacts and human health" brought up the subject. It stated that antibiotics are used in shrimp farming to prevent or treat disease outbreaks, just as they are used on factory farms, but usage patterns were unknown. That study was conducted along the coast of Thailand, which was the world's largest producer of cultured shrimp until China took that … [Read more...]

FDA and EPA Release Fish Consumption Advice

The FDA and EPA have issued advice about eating fish, geared toward pregnant women, women of child-bearing age, breastfeeding mothers, and parents of young children. The issue regarding fish consumption is mercury content. A reference chart sorts 62 types of fish into three categories: "Best choices" you can eat two to three times a week; "good choices" that you can eat once a week, and "fish to avoid." Fish in the "best choices" category include almost 90% of the fish eaten in this country. FDA conducted an analysis of fish consumption data and found that 50% of pregnant women surveyed ate less than 2 ounces a week. That is much less than the recommended amount. The nutritional benefits of eating fish are important for growth and development during pregnancy and early … [Read more...]

FDA Announces Sprout Guidance: What Took so Long?

After eight multistate food poisoning outbreaks linked to raw sprouts in the past five years, the FDA is finally issuing draft guidance for comments to help sprout operations meet new standards that are designed to keep this product safe. Raw sprouts are often contaminated with pathogenic bacteria, and the damp and warm growing conditions are the perfect medium for bacterial growth. The Produce Safety Rule, under the FDA Food Safety Modernization act of 2011, mandated new requirements for sprout operations. Sprouts are a unique food poisoning risk because the conditions under which they are grown are ideal for the growth of pathogenic bacteria. Between 1996 and July 2016 there were 46 food poisoning outbreaks associated with sprouts in the United States. They caused 2472 … [Read more...]

How to Report Problems to the FDA

The FDA is charged with making sure that foods and drugs are safe to eat and use. If you have a problem with a product that this agency regulates, you can report it. FDA regulates about 20% of the products sold in this country. They include human prescription and over-the-counter drugs; medical devices; foods, including dietary supplements, infant formulas, beverage, and ingredients added to foods; veterinary products, including foods and drugs for animals; electronic products that give off radiation; biologics, including vaccines, blood, and tissues for transplantation; and cosmetics. The FDA also regulates tobacco products. If you report a problem to the FDA, you could help identify a risk and protect others from harm. Your report could also help the FDA know when to trigger … [Read more...]

FDA Issues Draft Guidance for Control of Listeria in RTE Foods

The FDA is distributing a draft guidance, for comment purposes only, on the control of Listeria monocytogenes in ready to eat (RTE) foods. The guidance is for industry. All comments should be submitted electronically or written by July 17, 2017. The document is intended to help manufactures comply with current good manufacturing practices and risk-based preventive controls for human food. The final rule is the product of outreach by the FDA to industry, consumer groups, academia, and other stakeholders. The rule was first proposed in January 2013. There is zero tolerance for Listeria monocytogenes in ready to eat foods. This bacteria causes serious illness and death. It grows at refrigerator temperatures, and freezing does not kill it. Heating to 160°F is the only way to destroy … [Read more...]

Camel Milk Company Warned Over Health Claims

The FDA sent a letter to Desert Farms of Santa Monica, California, telling them that the claims they are making about the products they produce classify them as drugs, and they cannot sell them through interstate commerce. The FDA has threatened to seize products and may seek an injunction against Walid Abdul-Wahab and his company if changes are not made. The company's Facebook page posts therapeutic claims that state the milk products are "intended for use in the cure, mitigation, treatment, or prevention of disease." The products in question for sale are Raw Camel Milk (Fresh); Raw Camel Milk (Frozen); Raw Camel Milk Kefir (Fresh); Raw Camel Milk Kefir (Frozen); Pasteurized Camel Milk (Fresh); Pasteurized Camel Milk (Frozen); and Raw Camel Milk 1st Colostrum (Frozen); Raw Camel … [Read more...]

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